A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms

• ClinicalTrials.gov Identifier: NCT04430855
• Recruitment Status: Completed
• First Posted: June 12, 2020
• Results First Posted: February 6, 2023
• Last Update Posted: February 6, 2023
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hidradenitis Suppurativa (HS)
• Interventions: Drug: Upadacitinib; Drug: Placebo
• Enrollment: 68

Participant Flow

Recruitment Details	Participants were enrolled at 21 study sites in 3 countries (Canada, Japan, and United States/Puerto Rico).
Pre-assignment Details	Participants were randomized to upadacitinib or placebo in a 2:1 ratio. Randomization was stratified by anti-tumor necrosis factor (TNF) use prior to Baseline (yes or no) and Hurley stage (< III or III).

Arm/Group Title	Placebo / Upadacitinib 15 mg	Upadacitinib 30 mg
Arm/Group Description	Participants received matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2).	Participants received 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).
Period Title: Period 1 (Weeks 1-12)
Started	21	47
Received Study Drug	21	47
Completed	19	41
Not Completed	2	6
Reason Not Completed
Adverse Event	1	0
Withdrawal by Subject	1	2
Lost to Follow-up	0	2
Lack of Efficacy	0	1
Other	0	1
Period Title: Period 2 (Weeks 12-48)
Started	19	41
Completed	14	31
Not Completed	5	10
Reason Not Completed
Withdrawal by Subject	2	5
Lost to Follow-up	1	2
Lack of Efficacy	2	3

Baseline Characteristics

Arm/Group Title		Placebo / Upadacitinib 15 mg	Upadacitinib 30 mg	Total
Arm/Group Description		Participants received matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2).	Participants received 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).	Total of all reporting groups
Overall Number of Baseline Participants		21	47	68
Baseline Analysis Population Description		The Intent-to-treat (ITT) population includes all randomized participants
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	21 participants	47 participants	68 participants
		36.6 (12.49)	36.7 (11.70)	36.6 (11.85)
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	47 participants	68 participants
	< 40 years	15 71.4%	29 61.7%	44 64.7%
	40 - < 65 years	5 23.8%	17 36.2%	22 32.4%
	≥ 65 years	1 4.8%	1 2.1%	2 2.9%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	47 participants	68 participants
	Female	16 76.2%	37 78.7%	53 77.9%
	Male	5 23.8%	10 21.3%	15 22.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	47 participants	68 participants
	Hispanic or Latino	5 23.8%	9 19.1%	14 20.6%
	Not Hispanic or Latino	16 76.2%	38 80.9%	54 79.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	47 participants	68 participants
	American Indian or Alaska Native	0 0.0%	1 2.1%	1 1.5%
	Asian	3 14.3%	3 6.4%	6 8.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	7 33.3%	12 25.5%	19 27.9%
	White	11 52.4%	30 63.8%	41 60.3%
	More than one race	0 0.0%	1 2.1%	1 1.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Prior Exposure to Tumor Necrosis Factor (TNF) Antagonists; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	47 participants	68 participants
	Yes	6 28.6%	12 25.5%	18 26.5%
	No	15 71.4%	35 74.5%	50 73.5%
Hurley Stage [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	47 participants	68 participants
	Stage I	1 4.8%	0 0.0%	1 1.5%
	Stage II	11 52.4%	24 51.1%	35 51.5%
	Stage III	9 42.9%	23 48.9%	32 47.1%
		[1] Measure Description: The Hurley staging system is a grading system to characterize the extent of disease in patients with hidradenitis suppurativa. Hurley stages are described as follows: Stage I - Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring); Stage II - Single or multiple, widely separated, recurrent abscesses with tract formation and cicatrization; Stage III - Diffuse or near-diffuse involvement, or multiple interconnected tracts and abscesses across the entire area
Duration of Hidradenitis Suppurativa (HS) Disease; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	21 participants	47 participants	68 participants
		9.83 (4.990)	11.52 (9.401)	11.00 (8.290)
Abscess Lesion Count [1]; Mean (Standard Deviation); Unit of measure: Abscess lesions
	Number Analyzed	21 participants	47 participants	68 participants
		4.0 (3.29)	4.8 (6.39)	4.6 (5.60)
		[1] Measure Description: Abscesses are lesions that contain fluid, are tender or painful, with or without drainage.
Inflammatory Nodule Lesion Count [1]; Mean (Standard Deviation); Unit of measure: Nodule lesions
	Number Analyzed	21 participants	47 participants	68 participants
		15.7 (12.77)	18.4 (20.98)	17.6 (18.78)
		[1] Measure Description: Tender, small lumps under the skin that are inflamed or reddened,
Draining Fistula Lesion Count [1]; Mean (Standard Deviation); Unit of measure: Draining fistula lesions
	Number Analyzed	21 participants	47 participants	68 participants
		4.3 (6.17)	3.4 (4.74)	3.7 (5.19)
		[1] Measure Description: Horizontal channels (or tunnels) below the skin that connect the lesions and open into a sore on the skin surface that releases fluid (pus).
Abscess and Inflammatory Nodule (AN) Count; Mean (Standard Deviation); Unit of measure: Abscesses and inflammatory nodules
	Number Analyzed	21 participants	47 participants	68 participants
		19.8 (12.87)	23.2 (24.64)	22.1 (21.65)
Patient's Global Assessment (PGA) of Skin Pain Score [1] [2]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	20 participants	45 participants	65 participants
		4.852 (3.3237)	4.987 (2.7120)	4.945 (2.8879)
		[1] Measure Description: Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale (NRS) ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. Baseline PGA skin pain score is defined as the last non-missing weekly average score, calculated based on the daily scores from the past 7 days (with non-missing values in 4 or more days of the 7 day period), before the date of the first administration of study drug.; [2] Measure Analysis Population Description: Participants with available data
PGA Skin Pain Score In Participants with a Baseline Value ≥ 3 [1] [2]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	12 participants	33 participants	45 participants
		7.168 (2.0395)	6.180 (2.1107)	6.444 (2.1155)
		[1] Measure Description: Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. Baseline PGA skin pain score is defined as the last non-missing weekly average score, calculated based on the daily scores from the past 7 days (with non-missing values in 4 or more days of the 7 day period), before the date of the first administration of study drug.; [2] Measure Analysis Population Description: Participants with a Baseline PGA skin pain score ≥ 3

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Description	HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population; participants with missing data at Week 12 due to a missing assessment or early discontinuation, for reasons other than coronavirus disease 2019 (COVID-19), and participants who initiated antibiotics for HS-related infections prior to Week 12 were counted as non-responders (non-responder imputation); missing data due to COVID-19 infection or logistical restriction were handled by multiple imputation.

Arm/Group Title	Placebo	Upadacitinib 30 mg
Arm/Group Description:	Participants received matching placebo orally once a day for 12 weeks.	Participants received 30 mg upadacitinib orally once a day for 12 weeks.
Overall Number of Participants Analyzed	21	47
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	23.8; (5.6 to 42.0)	38.3; (24.4 to 52.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Upadacitinib 30 mg
	Comments	The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved HiSCR response to that of a prespecified, single historical placebo rate (25%). The historical placebo rate of 25% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.018
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Rate Difference
	Estimated Value	13.3
	Confidence Interval	(2-Sided) 95%; -0.6 to 27.2
	Estimation Comments	Response rate difference compared to historical placebo = upadacitinib 30 mg - historical placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Upadacitinib 30 mg
	Comments	As a supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo HiSCR data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic HiSCR was 29.2%.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.142
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage [Stage < III, Stage III] and prior TNF use [Yes or No])
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference
	Estimated Value	9.2
	Confidence Interval	(2-Sided) 95%; -7.6 to 25.9
	Estimation Comments	Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Upadacitinib 30 mg
	Comments	As an additional supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.087
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage [Stage < III, Stage III] and prior TNF use [Yes or No])
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 95%; -6.6 to 36.0
	Estimation Comments	Response rate difference = upadacitinib 30 mg - placebo

2. Secondary Outcome

Title	Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3
Description	The Patient's Global Assessment (PGA) of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. The weekly average score was calculated based on the daily scores from the 7 days prior to the visit (with non-missing values in 4 or more days of the 7 day period). NRS30 is defined as the percentage of participants who achieved at least a 30% reduction and at least 1 unit reduction from Baseline in the PGA of skin pain NRS in participants with Baseline skin pain NRS ≥ 3.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with Baseline skin pain NRS ≥ 3; participants with missing data at Week 12 due to a missing assessment or early discontinuation, for reasons other than COVID-19, and participants who initiated antibiotics for HS-related infections prior to Week 12 and under the impact of analgesic use at Week 12 were counted as non-responders (non-responder imputation); missing data due to COVID-19 infection or logistical restriction were handled by multiple imputation.

Arm/Group Title	Placebo	Upadacitinib 30 mg
Arm/Group Description:	Participants received matching placebo orally once a day for 12 weeks.	Participants received 30 mg upadacitinib orally once a day for 12 weeks.
Overall Number of Participants Analyzed	12	33
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	33.3; (6.7 to 60.0)	36.4; (20.0 to 52.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Upadacitinib 30 mg
	Comments	The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved NRS30 response to that of a prespecified, single historical placebo rate (22.5%). The historical placebo rate of 22.5% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.028
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Response Rate Difference
	Estimated Value	13.9
	Confidence Interval	(2-Sided) 95%; -2.5 to 30.3
	Estimation Comments	Response rate difference compared to historical placebo (upadacitinib 30 mg - historical placebo)

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Upadacitinib 30 mg
	Comments	As a supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo NRS30 data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic NRS30 was 31.3%.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.323
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage [Stage < III, Stage III] and prior TNF use [Yes or No])
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference
	Estimated Value	4.5
	Confidence Interval	(2-Sided) 95%; -14.6 to 23.5
	Estimation Comments	Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Upadacitinib 30 mg
	Comments	As an additional supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.421
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage [Stage < III, Stage III] and prior TNF use [Yes or No])
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; -19.6 to 24.0
	Estimation Comments	Response rate difference = upadacitinib 30 mg - placebo

Adverse Events

Time Frame	Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Period 1: Placebo		Period 1: Upadacitinib 30 mg		Period 2: Upadacitinib 15 mg		Period 2: Upadacitinib 30 mg
Arm/Group Description	Participants received matching placebo orally once a day for 12 weeks in Period 1.		Participants received 30 mg upadacitinib orally once a day for 12 weeks in Period 1.		Participants originally assigned to placebo received 15 mg upadacitinib orally once a day for 36 weeks in Period 2.		Participants originally assigned to upadacitinib 30 mg continued to receive 30 mg upadacitinib orally once a day for 36 weeks in Period 2.
All-Cause Mortality
	Period 1: Placebo		Period 1: Upadacitinib 30 mg		Period 2: Upadacitinib 15 mg		Period 2: Upadacitinib 30 mg
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/21 (0.00%)		0/47 (0.00%)		0/19 (0.00%)		0/41 (0.00%)
Serious Adverse Events
	Period 1: Placebo		Period 1: Upadacitinib 30 mg		Period 2: Upadacitinib 15 mg		Period 2: Upadacitinib 30 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0.00%)		3/47 (6.38%)		0/19 (0.00%)		5/41 (12.20%)
Hepatobiliary disorders
CHOLECYSTITIS † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	0/19 (0.00%)	0	1/41 (2.44%)	1
Infections and infestations
COVID-19 PNEUMONIA † 1	0/21 (0.00%)	0	1/47 (2.13%)	1	0/19 (0.00%)	0	0/41 (0.00%)	0
CELLULITIS † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	0/19 (0.00%)	0	1/41 (2.44%)	1
Psychiatric disorders
ADJUSTMENT DISORDER † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	0/19 (0.00%)	0	1/41 (2.44%)	1
DEPRESSION † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	0/19 (0.00%)	0	1/41 (2.44%)	1
SUICIDAL BEHAVIOUR † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	0/19 (0.00%)	0	1/41 (2.44%)	1
SUICIDAL IDEATION † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	0/19 (0.00%)	0	1/41 (2.44%)	1
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE † 1	0/21 (0.00%)	0	1/47 (2.13%)	1	0/19 (0.00%)	0	0/41 (0.00%)	0
Skin and subcutaneous tissue disorders
HIDRADENITIS † 1	0/21 (0.00%)	0	1/47 (2.13%)	1	0/19 (0.00%)	0	0/41 (0.00%)	0
SKIN PLAQUE † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	0/19 (0.00%)	0	1/41 (2.44%)	1
Surgical and medical procedures
ABORTION INDUCED † 1	0/21 (0.00%)	0	1/47 (2.13%)	1	0/19 (0.00%)	0	0/41 (0.00%)	0
Vascular disorders
HYPOTENSION † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	0/19 (0.00%)	0	1/41 (2.44%)	1
1 Term from vocabulary, MedDRA 24.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Period 1: Placebo		Period 1: Upadacitinib 30 mg		Period 2: Upadacitinib 15 mg		Period 2: Upadacitinib 30 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/21 (28.57%)		12/47 (25.53%)		10/19 (52.63%)		12/41 (29.27%)
Gastrointestinal disorders
ABDOMINAL PAIN UPPER † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	1/19 (5.26%)	1	0/41 (0.00%)	0
General disorders
CHILLS † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	1/19 (5.26%)	1	0/41 (0.00%)	0
FATIGUE † 1	1/21 (4.76%)	1	1/47 (2.13%)	1	1/19 (5.26%)	1	1/41 (2.44%)	1
MALAISE † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	1/19 (5.26%)	1	1/41 (2.44%)	1
PYREXIA † 1	1/21 (4.76%)	1	0/47 (0.00%)	0	1/19 (5.26%)	1	2/41 (4.88%)	2
Infections and infestations
BRONCHITIS † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	1/19 (5.26%)	1	0/41 (0.00%)	0
CELLULITIS † 1	2/21 (9.52%)	2	0/47 (0.00%)	0	0/19 (0.00%)	0	0/41 (0.00%)	0
URINARY TRACT INFECTION † 1	0/21 (0.00%)	0	3/47 (6.38%)	4	0/19 (0.00%)	0	2/41 (4.88%)	2
Musculoskeletal and connective tissue disorders
BACK PAIN † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	1/19 (5.26%)	1	0/41 (0.00%)	0
MYALGIA † 1	2/21 (9.52%)	2	1/47 (2.13%)	1	0/19 (0.00%)	0	1/41 (2.44%)	1
NECK PAIN † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	2/19 (10.53%)	2	0/41 (0.00%)	0
Nervous system disorders
DIZZINESS † 1	0/21 (0.00%)	0	3/47 (6.38%)	3	0/19 (0.00%)	0	0/41 (0.00%)	0
HEADACHE † 1	0/21 (0.00%)	0	5/47 (10.64%)	5	2/19 (10.53%)	2	2/41 (4.88%)	2
Psychiatric disorders
ABNORMAL DREAMS † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	1/19 (5.26%)	1	0/41 (0.00%)	0
Skin and subcutaneous tissue disorders
ACNE † 1	1/21 (4.76%)	1	1/47 (2.13%)	1	0/19 (0.00%)	0	3/41 (7.32%)	4
DERMATITIS † 1	3/21 (14.29%)	3	0/47 (0.00%)	0	1/19 (5.26%)	1	0/41 (0.00%)	0
ECZEMA † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	1/19 (5.26%)	1	0/41 (0.00%)	0
HIDRADENITIS † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	3/19 (15.79%)	4	3/41 (7.32%)	3
PERIORAL DERMATITIS † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	1/19 (5.26%)	1	0/41 (0.00%)	0
PRURITUS ALLERGIC † 1	0/21 (0.00%)	0	0/47 (0.00%)	0	1/19 (5.26%)	1	0/41 (0.00%)	0
1 Term from vocabulary, MedDRA 24.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

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.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact

• Name/Title: Global Medical Services
• Organization: AbbVie
• Phone: 800-633-9110
• EMail: abbvieclinicaltrials@abbvie.com

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT04430855
• Other Study ID Numbers: M20-040
• First Submitted: June 11, 2020
• First Posted: June 12, 2020
• Results First Submitted: January 10, 2023
• Results First Posted: February 6, 2023
• Last Update Posted: February 6, 2023