Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate2)

• ClinicalTrials.gov Identifier: NCT04178967
• Recruitment Status: Completed
• First Posted: November 26, 2019
• Results First Posted: September 16, 2022
• Last Update Posted: September 16, 2022
• Sponsor: Eli Lilly and Company
• Collaborator: Dermira, Inc.
• Information provided by (Responsible Party): Eli Lilly and Company

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Atopic Dermatitis
• Interventions: Biological: Lebrikizumab; Other: Placebo
• Enrollment: 445

Participant Flow

Recruitment Details
Pre-assignment Details	Reported are results for the Induction Period (Baseline to Week16). Results will be updated to report the data collected up to study completion.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Period Title: Overall Study
Started	150	295
Received at Least One Dose of Study Drug	149	295
Re-randomized to Maintenance Blinded Treatment	25	148
Enrolled to Escape Arm at Week 16	108	125
Completed	133	273
Not Completed	17	22
Reason Not Completed
Adverse Event	4	6
Due to Epidemic/Pandemic	0	1
Lack of Efficacy	3	1
Protocol Violation	0	7
Withdrawal by Subject	8	7
Lost to Follow-up	2	0

Baseline Characteristics

Arm/Group Title		Placebo	Lebrikizumab Q2W	Total
Arm/Group Description		Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.	Total of all reporting groups
Overall Number of Baseline Participants		150	295	445
Baseline Analysis Population Description		All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to Good Clinical Practice (GCP) issues.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants	295 participants	445 participants
	<=18 years	17	33	50
	Between 18 and 65 years	123	239	362
	>=65 years	10	23	33
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	150 participants	295 participants	445 participants
		35.6 (17.15)	36.5 (16.64)	36.2 (16.80)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants	295 participants	445 participants
	Female	79	147	226
	Male	71	148	219
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants	295 participants	445 participants
	American Indian or Alaska Native	2	3	5
	Asian	44	78	122
	Native Hawaiian or Other Pacific Islander	1	2	3
	Black or African American	10	26	36
	White	89	181	270
	More than one race	3	4	7
	Unknown or Not Reported	1	1	2
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	150 participants	295 participants	445 participants
Canada		16	42	58
Singapore		8	11	19
United States		64	121	185
Taiwan		21	39	60
Ukraine		3	8	11
Mexico		3	6	9
Bulgaria		7	15	22
Germany		28	53	81

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
Description	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to Good Clinical Practice (GCP) issues. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	10.9; (5.7 to 16.1)	33.1; (27.4 to 38.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000004
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	21.7
	Confidence Interval	(2-Sided) 95%; 14.1 to 29.4
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16
Description	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	18.2; (11.8 to 24.6)	50.8; (44.9 to 56.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	32.1
	Confidence Interval	(2-Sided) 95%; 23.2 to 41.0
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2
Description	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time Frame	Baseline to Week 2

Outcome Measure Data

Analysis Population Description

All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	0; (0.0 to 0.0)	0.7; (-0.3 to 1.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.305686
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -0.3 to 1.8
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4
Description	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	1.4; (-0.5 to 3.3)	9.0; (5.6 to 12.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001635
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	8.1
	Confidence Interval	(2-Sided) 95%; 4.1 to 12.2
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 in Adults
Description	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

All randomized adult participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	129	251
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	11.6; (5.9 to 17.2)	31.8; (25.9 to 37.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000032
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	20.3
	Confidence Interval	(2-Sided) 95%; 12.2 to 28.5
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16
Description	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	9.4; (4.5 to 14.2)	30.2; (24.7 to 35.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000009
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	20.3
	Confidence Interval	(2-Sided) 95%; 12.9 to 27.8
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Percentage Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Description	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis of covariance (ANCOVA) model with treatment and randomization strata (region, disease severity, age) as fixed factors and baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with a Baseline Pruritus NRS score >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Least Squares Mean (Standard Error); Unit of Measure: percentage change
	-8.91 (3.908)	-35.67 (3.357)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-26.76
	Confidence Interval	(2-Sided) 95%; -34.3 to -19.3
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16
Description	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with a Baseline Pruritus NRS score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	134	253
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	11.3; (5.9 to 16.8)	38.3; (32.2 to 44.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	26.9
	Confidence Interval	(2-Sided) 95%; 18.7 to 35.0
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16
Description	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with Baseline Pruritus NRS score ≥ 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	122	234
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	11.6; (5.9 to 17.4)	40.0; (33.6 to 46.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	28.1
	Confidence Interval	(2-Sided) 95%; 19.6 to 36.7
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Percentage Change in EASI Score From Baseline to Week 16
Description	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). LS Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Least Squares Mean (Standard Error); Unit of Measure: percent change
	-28.22 (3.873)	-60.61 (3.268)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-32.39
	Confidence Interval	(2-Sided) 95%; -39.9 to -24.9
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Change From Baseline in Percent Body Surface Area (BSA) at Week 16
Description	The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with observed BSA data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. The MMRM included treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	77	209
Least Squares Mean (Standard Error); Unit of Measure: percentage of BSA
	-13.76 (1.926)	-29.65 (1.330)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-15.88
	Confidence Interval	(2-Sided) 95%; -20.04 to -11.73
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Percentage of Participants Achieving EASI-90 From Baseline to Week 4
Description	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	1.4; (-0.5 to 3.4)	6.4; (3.4 to 9.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.020407
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.0
	Confidence Interval	(2-Sided) 95%; 1.5 to 8.5
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Description	The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with non-missing baseline DLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	118	218
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-2.47 (1.164)	-6.99 (1.152)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-4.52
	Confidence Interval	(2-Sided) 95%; -5.9 to -3.1
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Percentage of Participants Achieving ≥4-point Improvement in DLQI From Baseline to Week 16
Description	The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with non-missing baseline DLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	118	218
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	33.7; (24.9 to 42.6)	63.5; (57.0 to 70.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	29.9
	Confidence Interval	(2-Sided) 95%; 19.1 to 40.8
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Percentage of Participants With a DLQI Total Score of ≥4-point Achieving ≥4-point Improvement in DLQI From Baseline to Week 16
Description	The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with a DLQI Total Score of ≥4-point at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	115	215
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	34.6; (25.6 to 43.6)	64.4; (57.8 to 70.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	29.9
	Confidence Interval	(2-Sided) 95%; 18.9 to 40.9
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Percentage Change in Sleep-loss Score From Baseline to Week 16
Description	Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with baseline sleep-loss score >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Least Squares Mean (Standard Error); Unit of Measure: percent change
	-11.40 (5.420)	-47.24 (4.610)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-35.84
	Confidence Interval	(2-Sided) 95%; -46.2 to -25.5
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Change From Baseline in Sleep-loss Score at Week 16
Description	Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with non-missing baseline Sleep-loss score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-0.35 (0.097)	-1.02 (0.080)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-0.67
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.5
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline to Week 16
Description	Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary.
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with baseline sleep-loss score ≥2 Points, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	97	161
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	7.8; (2.2 to 13.4)	26.5; (19.6 to 33.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000842
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	17.9
	Confidence Interval	(2-Sided) 95%; 8.8 to 27.0
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
Description	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time Frame	Baseline to Week 1

Outcome Measure Data

Analysis Population Description

All randomized participants, with a Pruritus NRS Score of ≥4 Points at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	134	253
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	0.0; (0.0 to 0.0)	0.4; (0.0 to 1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.469221
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -0.4 to 1.2
	Estimation Comments	[Not Specified]

20. Secondary Outcome

Title	Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
Description	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time Frame	Baseline to Week 2

Outcome Measure Data

Analysis Population Description

All randomized participants, with a Pruritus NRS Score of ≥4 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	134	253
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	0.7; (0.0 to 2.2)	3.6; (1.3 to 5.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.118893
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; -0.1 to 5.3
	Estimation Comments	[Not Specified]

21. Secondary Outcome

Title	Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
Description	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

All randomized participants, with a Pruritus NRS Score of ≥4 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	134	253
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	3.0; (0.1 to 5.9)	16.8; (12.2 to 21.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000216
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	13.2
	Confidence Interval	(2-Sided) 95%; 7.7 to 18.7
	Estimation Comments	[Not Specified]

22. Secondary Outcome

Title	Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
Description	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time Frame	Baseline to Week 1

Outcome Measure Data

Analysis Population Description

All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	122	234
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	0.0; (0.0 to 0.0)	0.4; (0.0 to 1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.468160
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -0.4 to 1.3
	Estimation Comments	[Not Specified]

23. Secondary Outcome

Title	Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
Description	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time Frame	Baseline to Week 2

Outcome Measure Data

Analysis Population Description

All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	122	234
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	0.8; (0.0 to 2.4)	3.8; (1.4 to 6.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.121327
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; -0.1 to 5.8
	Estimation Comments	[Not Specified]

24. Secondary Outcome

Title	Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
Description	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

All randomized participants, with a Pruritus NRS Score of ≥5 Points at Baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MCMC-MI was used to handle missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	122	234
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	3.3; (0.1 to 6.5)	18.1; (13.2 to 23.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000238
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	14.2
	Confidence Interval	(2-Sided) 95%; 8.3 to 20.2
	Estimation Comments	[Not Specified]

25. Secondary Outcome

Title	Percentage Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
Description	The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Mean was calculated using the ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with baseline SCORAD >0, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing Values were imputed using last observation carried forward (LOCF) method.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Least Squares Mean (Standard Error); Unit of Measure: percent change
	-13.87 (3.201)	-43.85 (2.680)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-29.98
	Confidence Interval	(2-Sided) 95%; -36.16 to -23.80
	Estimation Comments	[Not Specified]

26. Secondary Outcome

Title	Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab
Description	[Not Specified]
Time Frame	Baseline through Week 52

Outcome Measure Data Not Reported

27. Secondary Outcome

Title	Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continue to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)
Description	[Not Specified]
Time Frame	Baseline to Week 52

Outcome Measure Data Not Reported

28. Secondary Outcome

Title	Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 16 Who Continue to Exhibit an IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 52
Description	[Not Specified]
Time Frame	Baseline to Week 52

Outcome Measure Data Not Reported

29. Secondary Outcome

Title	Percentage of Participants From Those With a Pruritus NRS of ≥4-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52
Description	[Not Specified]
Time Frame	Baseline to Week 52

Outcome Measure Data Not Reported

30. Secondary Outcome

Title	Percentage of Participants From Those With a Pruritus NRS of ≥5-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52
Description	[Not Specified]
Time Frame	Baseline to Week 52

Outcome Measure Data Not Reported

31. Secondary Outcome

Title	Percentage Change in SCORAD (Having Achieved EASI-75 at Week 16) From Baseline at Week 52
Description	[Not Specified]
Time Frame	Baseline, Week 52

Outcome Measure Data Not Reported

32. Secondary Outcome

Title	Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index
Description	The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with non-missing EQ-5D-5L data at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing Values were imputed using last observation carried forward (LOCF) method.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	146	281
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
Health State Index UK	0.04 (0.018)	0.12 (0.015)
Health State Index US	0.03 (0.013)	0.08 (0.011)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	UK
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000011
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.11
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	US
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000012
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; 0.03 to 0.08
	Estimation Comments	[Not Specified]

33. Secondary Outcome

Title	Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)
Description	The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with non-missing EQ-5D-5L data at baseline, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	145	277
Least Squares Mean (Standard Error); Unit of Measure: millimeters (mm)
	5.23 (1.578)	8.97 (1.325)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.016649
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	3.73
	Confidence Interval	(2-Sided) 95%; 0.68 to 6.79
	Estimation Comments	[Not Specified]

34. Secondary Outcome

Title	Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
Description	POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with observed POEM data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MMRM was used to handle all missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	65	184
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-3.45 (0.773)	-9.55 (0.525)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.000001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-6.10
	Confidence Interval	(2-Sided) 95%; -7.81 to -4.39
	Estimation Comments	[Not Specified]

35. Secondary Outcome

Title	Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents
Description	PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized, adolescent participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	17	30
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.12 (2.129)	-2.79 (1.550)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.241275
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-2.91
	Confidence Interval	(2-Sided) 95%; -7.85 to 2.03
	Estimation Comments	[Not Specified]

36. Secondary Outcome

Title	Change From Baseline in PROMIS Anxiety at Week 16 - Adults
Description	PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized, adults participants, with Week 16 PROMIS anxiety data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing Values were imputed using LOCF method.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	129	251
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-0.43 (0.572)	-3.00 (0.416)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000226
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-2.58
	Confidence Interval	(2-Sided) 95%; -3.94 to -1.22
	Estimation Comments	[Not Specified]

37. Secondary Outcome

Title	Change From Baseline in PROMIS Depression at Week 16- Adolescents
Description	PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized, adolescent participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	17	30
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-0.57 (2.047)	-1.67 (1.493)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.645132
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-1.10
	Confidence Interval	(2-Sided) 95%; -5.86 to 3.67
	Estimation Comments	[Not Specified]

38. Secondary Outcome

Title	Change From Baseline in PROMIS Depression at Week 16- Adults
Description	PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized, adult participants, with Week 16 PROMIS Depression data, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	129	251
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.19 (0.533)	-2.38 (0.387)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.000081
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-2.57
	Confidence Interval	(2-Sided) 95%; -3.84 to -1.30
	Estimation Comments	[Not Specified]

39. Secondary Outcome

Title	Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma
Description	The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicate lower asthma control. LS Mean was calculated using ANCOVA with treatment, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants, with non-missing baseline ACQ-5 score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	35	75
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.19 (0.138)	0.20 (0.106)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.919129
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; -0.25 to 0.28
	Estimation Comments	[Not Specified]

40. Secondary Outcome

Title	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16
Description	The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized, adolescent participants, with non-missing baseline CDLQI score, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with eighteen participants was excluded from analysis due to GCP issues. MMRM was used to handle all missing data.

Arm/Group Title	Placebo	Lebrikizumab Q2W
Arm/Group Description:	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.	Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Overall Number of Participants Analyzed	4	17
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-4.13 (2.276)	-7.49 (1.120)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lebrikizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.196507
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference (Final Values)
	Estimated Value	-3.37
	Confidence Interval	(2-Sided) 95%; -8.59 to 1.86
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Baseline up to Week 16
Adverse Event Reporting Description	All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Results will be updated to report the data collected up to study completion.
Arm/Group Title	Placebo		Lebrikizumab Q2W
Arm/Group Description	Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.		Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
All-Cause Mortality
	Placebo		Lebrikizumab Q2W
	Affected / at Risk (%)		Affected / at Risk (%)
Total	1/149 (0.67%)		0/295 (0.00%)
Serious Adverse Events
	Placebo		Lebrikizumab Q2W
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/149 (2.68%)		2/295 (0.68%)
Cardiac disorders
Cardiac failure † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Myocardial infarction † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Infections and infestations
Large intestine infection † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Injury, poisoning and procedural complications
Fibula fracture † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Multiple injuries † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Tibia fracture † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma † 1	1/78 (1.28%)	1	0/147 (0.00%)	0
Nervous system disorders
Cerebellar syndrome † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Skin and subcutaneous tissue disorders
Dermatitis atopic † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
1 Term from vocabulary, MedDRA 24.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Placebo		Lebrikizumab Q2W
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	97/149 (65.10%)		155/295 (52.54%)
Blood and lymphatic system disorders
Eosinophilia † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Iron deficiency anaemia † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Lymphadenitis † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Lymphadenopathy † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Lymphocytosis † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Lymphopenia † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Cardiac disorders
Tachycardia † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Ear and labyrinth disorders
Ear discomfort † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Paraesthesia ear † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Tinnitus † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Vertigo † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Eye disorders
Atopic keratoconjunctivitis † 1	0/149 (0.00%)	0	2/295 (0.68%)	3
Blepharitis † 1	1/149 (0.67%)	1	2/295 (0.68%)	3
Cataract † 1	2/149 (1.34%)	2	1/295 (0.34%)	1
Conjunctivitis allergic † 1	2/149 (1.34%)	2	6/295 (2.03%)	6
Dark circles under eyes † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Dermatochalasis † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Dry eye † 1	0/149 (0.00%)	0	7/295 (2.37%)	8
Episcleritis † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Eye discharge † 1	0/149 (0.00%)	0	2/295 (0.68%)	2
Eye pruritus † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Eyelid erosion † 1	2/149 (1.34%)	2	0/295 (0.00%)	0
Keratitis † 1	0/149 (0.00%)	0	1/295 (0.34%)	2
Lacrimation increased † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Ocular hyperaemia † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Vision blurred † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Vitreous floaters † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Gastrointestinal disorders
Abdominal pain † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Breath odour † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Constipation † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Diarrhoea † 1	1/149 (0.67%)	1	2/295 (0.68%)	2
Dyspepsia † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Flatulence † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Gastrointestinal inflammation † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Haematemesis † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Haemorrhoids † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Hiatus hernia † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Inguinal hernia † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Nausea † 1	1/149 (0.67%)	1	4/295 (1.36%)	4
Toothache † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Vomiting † 1	0/149 (0.00%)	0	1/295 (0.34%)	2
General disorders
Chills † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Cyst rupture † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Fatigue † 1	1/149 (0.67%)	1	3/295 (1.02%)	3
Injection site discomfort † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Injection site erythema † 1	0/149 (0.00%)	0	2/295 (0.68%)	3
Injection site pain † 1	1/149 (0.67%)	1	3/295 (1.02%)	4
Injection site reaction † 1	0/149 (0.00%)	0	2/295 (0.68%)	2
Injection site swelling † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Malaise † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Oedema † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Oedema peripheral † 1	1/149 (0.67%)	2	0/295 (0.00%)	0
Peripheral swelling † 1	1/149 (0.67%)	2	0/295 (0.00%)	0
Swelling † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Immune system disorders
Allergy to animal † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Drug hypersensitivity † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Seasonal allergy † 1	1/149 (0.67%)	1	3/295 (1.02%)	4
Infections and infestations
Abscess † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Asymptomatic bacteriuria † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Body tinea † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Conjunctivitis † 1	3/149 (2.01%)	3	22/295 (7.46%)	23
Conjunctivitis bacterial † 1	0/149 (0.00%)	0	3/295 (1.02%)	3
Covid-19 † 1	2/149 (1.34%)	2	2/295 (0.68%)	2
Cystitis † 1	1/149 (0.67%)	1	2/295 (0.68%)	2
Dermatitis infected † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Eczema herpeticum † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Eczema impetiginous † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Eczema infected † 1	0/149 (0.00%)	0	1/295 (0.34%)	2
Erysipelas † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Folliculitis † 1	3/149 (2.01%)	3	1/295 (0.34%)	1
Gastroenteritis † 1	1/149 (0.67%)	1	3/295 (1.02%)	4
Genital herpes simplex † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Herpes dermatitis † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Herpes simplex † 1	0/149 (0.00%)	0	2/295 (0.68%)	3
Herpes zoster † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Hordeolum † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Impetigo † 1	3/149 (2.01%)	3	0/295 (0.00%)	0
Large intestine infection † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Nasopharyngitis † 1	3/149 (2.01%)	3	15/295 (5.08%)	17
Oral herpes † 1	3/149 (2.01%)	3	4/295 (1.36%)	4
Oral infection † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Otitis externa † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Paronychia † 1	0/149 (0.00%)	0	2/295 (0.68%)	2
Pharyngitis † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Pharyngitis streptococcal † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Pharyngotonsillitis † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Post procedural infection † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Pustule † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Rhinitis † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Skin infection † 1	0/149 (0.00%)	0	1/295 (0.34%)	2
Superinfection † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Tinea infection † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Tinea pedis † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Tooth abscess † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Tooth infection † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Upper respiratory tract infection † 1	2/149 (1.34%)	2	0/295 (0.00%)	0
Urinary tract infection † 1	1/149 (0.67%)	1	4/295 (1.36%)	4
Viral infection † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Vulvovaginal candidiasis † 1	1/78 (1.28%)	1	0/147 (0.00%)	0
Injury, poisoning and procedural complications
Accident at work † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Animal bite † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Clavicle fracture † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Concussion † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Contusion † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Epicondylitis † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Fall † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Fibula fracture † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Hand fracture † 1	0/149 (0.00%)	0	2/295 (0.68%)	2
Injection related reaction † 1	1/149 (0.67%)	2	0/295 (0.00%)	0
Injury corneal † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Joint dislocation † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Ligament sprain † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Limb injury † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Muscle strain † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Overdose † 1	1/149 (0.67%)	1	3/295 (1.02%)	4
Post procedural complication † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Procedural headache † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Procedural pain † 1	2/149 (1.34%)	2	0/295 (0.00%)	0
Skin abrasion † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Skin laceration † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Thermal burn † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Tibia fracture † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Vaccination complication † 1	0/149 (0.00%)	0	2/295 (0.68%)	3
Wound dehiscence † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Wrist fracture † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Investigations
Blood alkaline phosphatase increased † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Blood pressure increased † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Eosinophil count increased † 1	0/149 (0.00%)	0	2/295 (0.68%)	2
Gamma-glutamyltransferase increased † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Neutrophil count decreased † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Neutrophil count increased † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Nitrite urine present † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Platelet count increased † 1	2/149 (1.34%)	2	1/295 (0.34%)	1
White blood cell count increased † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Metabolism and nutrition disorders
Decreased appetite † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Hypercholesterolaemia † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Hypoglycaemia † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Obesity † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/149 (0.67%)	1	3/295 (1.02%)	3
Arthritis † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Bursitis † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Coccydynia † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Joint swelling † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Limb discomfort † 1	0/149 (0.00%)	0	1/295 (0.34%)	2
Muscle spasms † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Pain in extremity † 1	1/149 (0.67%)	2	1/295 (0.34%)	1
Synovial cyst † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Fibroadenoma of breast † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Skin papilloma † 1	0/149 (0.00%)	0	3/295 (1.02%)	3
Squamous cell carcinoma † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Nervous system disorders
Burning sensation † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Cerebellar syndrome † 1	0/149 (0.00%)	0	1/295 (0.34%)	2
Dizziness † 1	0/149 (0.00%)	0	4/295 (1.36%)	4
Headache † 1	8/149 (5.37%)	8	15/295 (5.08%)	17
Hypoaesthesia † 1	2/149 (1.34%)	2	1/295 (0.34%)	1
Neuralgia † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Paraesthesia † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Psychiatric disorders
Anxiety † 1	2/149 (1.34%)	2	0/295 (0.00%)	0
Depression † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Insomnia † 1	1/149 (0.67%)	2	1/295 (0.34%)	1
Middle insomnia † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Panic attack † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Sleep disorder † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Renal and urinary disorders
Bladder disorder † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Nephrolithiasis † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Renal pain † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Reproductive system and breast disorders
Breast ulceration † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Heavy menstrual bleeding † 1	1/78 (1.28%)	1	0/147 (0.00%)	0
Vulvovaginal dryness † 1	0/78 (0.00%)	0	1/147 (0.68%)	1
Respiratory, thoracic and mediastinal disorders
Asthma † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Cough † 1	0/149 (0.00%)	0	2/295 (0.68%)	2
Dyspnoea † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Nasal congestion † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Oropharyngeal pain † 1	1/149 (0.67%)	1	2/295 (0.68%)	2
Rhinitis allergic † 1	1/149 (0.67%)	1	3/295 (1.02%)	3
Sinus congestion † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Skin and subcutaneous tissue disorders
Acne † 1	3/149 (2.01%)	3	1/295 (0.34%)	1
Alopecia † 1	0/149 (0.00%)	0	2/295 (0.68%)	2
Alopecia areata † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Angioedema † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Dermatitis † 1	1/149 (0.67%)	1	2/295 (0.68%)	2
Dermatitis atopic † 1	37/149 (24.83%)	40	27/295 (9.15%)	30
Dermatitis contact † 1	2/149 (1.34%)	2	1/295 (0.34%)	1
Dermatitis exfoliative generalised † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Dermatitis psoriasiform † 1	0/149 (0.00%)	0	2/295 (0.68%)	2
Diffuse alopecia † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Dyshidrotic eczema † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Eczema † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Erythema † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Hair disorder † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Night sweats † 1	0/149 (0.00%)	0	2/295 (0.68%)	2
Pityriasis rosea † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Prurigo † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Pruritus † 1	1/149 (0.67%)	1	5/295 (1.69%)	5
Rash † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Rash erythematous † 1	1/149 (0.67%)	2	0/295 (0.00%)	0
Rosacea † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Seborrhoea † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Skin fissures † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Skin lesion inflammation † 1	1/149 (0.67%)	1	1/295 (0.34%)	1
Urticaria † 1	1/149 (0.67%)	1	2/295 (0.68%)	3
Vascular disorders
Haematoma † 1	1/149 (0.67%)	1	0/295 (0.00%)	0
Hot flush † 1	0/149 (0.00%)	0	1/295 (0.34%)	1
Hypertension † 1	2/149 (1.34%)	2	2/295 (0.68%)	2
1 Term from vocabulary, MedDRA 24.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

One investigational site with eighteen participants was excluded from analysis due to GCP issues.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Chief Medical Officer
• Organization: Eli Lilly and Company
• Phone: 8005455979
• EMail: ClinicalTrials.gov@lilly.com

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04178967
• Other Study ID Numbers: 17802; 2019-002933-12 ( EudraCT Number ); J2T-DM-KGAC ( Other Identifier: Eli Lilly and Company ); DRM06-AD05 ( Other Identifier: Dermira, Inc )
• First Submitted: November 25, 2019
• First Posted: November 26, 2019
• Results First Submitted: July 11, 2022
• Results First Posted: September 16, 2022
• Last Update Posted: September 16, 2022