A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (DETERMINED 1)

• ClinicalTrials.gov Identifier: NCT03926169
• Recruitment Status: Completed
• First Posted: April 24, 2019
• Results First Posted: August 11, 2022
• Last Update Posted: August 11, 2022
• 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
• Interventions: Drug: Risankizumab; Drug: Placebo for risankizumab
• Enrollment: 243

Participant Flow

Recruitment Details
Pre-assignment Details	In Period A, participants who met the study's eligibility criteria were randomized at the Baseline Visit, in a 1:1:1 ratio, to receive either placebo, risankizumab 180 mg or 360 mg via a subcutaneous (SC) injection.

Arm/Group Title	Placebo / Risankizumab 360 mg	Risankizumab 180 mg / Risankizumab 360 mg	Risankizumab 360 mg / Risankizumab 360 mg
Arm/Group Description	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
Period Title: Period A
Started [1]	82	80	81
Never Received Study Drug	0	0	1
Completed [2]	74	70	75
Not Completed	8	10	6
Reason Not Completed
Adverse Event	2	2	1
Withdrawal by Subject	2	2	2
Lost to Follow-up	3	1	0
Lack of Efficacy	0	2	2
COVID-19 Infection	0	1	0
COVID-19 Logistical Restrictions	0	2	1
Other, Not Specified	1	0	0
[1] Randomized; [2] Completed Week 16
Period Title: Period B
Started [1]	74	70	75
Entered Period B and Received Study Drug	74	70	74
Completed [2]	4	7	4
Not Completed	70	63	71
Reason Not Completed
Adverse Event	3	1	1
Withdrawal by Subject	1	3	0
Lack of Efficacy	3	1	1
Lost to Follow-up	1	1	4
Other, Not Specified	62	57	65
[1] Entered Period B; [2] Completed study

Baseline Characteristics

Arm/Group Title		Placebo / Risankizumab 360 mg	Risankizumab 180 mg / Risankizumab 360 mg	Risankizumab 360 mg / Risankizumab 360 mg	Total
Arm/Group Description		In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.	Total of all reporting groups
Overall Number of Baseline Participants		82	80	81	243
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	82 participants	80 participants	81 participants	243 participants
		37.2 (11.97)	38.9 (11.45)	38.2 (11.99)	38.1 (11.77)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants	80 participants	81 participants	243 participants
	Female	48 58.5%	53 66.3%	51 63.0%	152 62.6%
	Male	34 41.5%	27 33.8%	30 37.0%	91 37.4%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	82 participants	80 participants	81 participants	243 participants
Hispanic or Latino		9 11.0%	10 12.5%	7 8.6%	26 10.7%
Not Hispanic or Latino		73 89.0%	70 87.5%	74 91.4%	217 89.3%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	82 participants	80 participants	81 participants	243 participants
White		68 82.9%	63 78.8%	62 76.5%	193 79.4%
Black or African American		4 4.9%	12 15.0%	9 11.1%	25 10.3%
Asian		8 9.8%	4 5.0%	9 11.1%	21 8.6%
American Indian or Alaska Native		0 0.0%	1 1.3%	0 0.0%	1 0.4%
Multiple Races		2 2.4%	0 0.0%	1 1.2%	3 1.2%
Abscess and Inflammatory Nodule (AN) Count; Mean (Standard Deviation); Unit of measure: Abscess and inflammatory nodules
	Number Analyzed	82 participants	80 participants	81 participants	243 participants
		15.7 (28.42)	13.7 (11.42)	12.5 (8.24)	14.0 (18.36)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Description	HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.
Time Frame	Baseline (Week 0), Week 16

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population: all randomized participants. Non-responder imputation with multiple imputation to handle missing data due to COVID-19 (NRI-C) .

Arm/Group Title	Placebo	Risankizumab 180 mg	Risankizumab 360 mg
Arm/Group Description:	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Overall Number of Participants Analyzed	82	80	81
Measure Type: Number; Number (97.5% Confidence Interval); Unit of Measure: percentage of participants
	41.5; (29.3 to 53.7)	46.8; (34.2 to 59.4)	43.4; (31.0 to 55.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 180 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.422
	Comments	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference (%)
	Estimated Value	6.0
	Confidence Interval	(2-Sided) 97.5%; -10.8 to 22.8
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 360 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.858
	Comments	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference (%)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 97.5%; -15.4 to 18.1
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
Description	NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.
Time Frame	Baseline (Week 0) to Week 8

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation with multiple imputation to handle missing data due to COVID-19.

Arm/Group Title	Placebo	Risankizumab 180 mg	Risankizumab 360 mg
Arm/Group Description:	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Overall Number of Participants Analyzed	61	61	60
Measure Type: Number; Number (97.5% Confidence Interval); Unit of Measure: percentage of participants
	33.0; (19.4 to 46.5)	29.2; (15.9 to 42.6)	40.0; (25.8 to 54.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 180 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.725
	Comments	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference (%)
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 97.5%; -21.8 to 15.9
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 360 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.301
	Comments	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference (%)
	Estimated Value	8.8
	Confidence Interval	(2-Sided) 97.5%; -10.3 to 27.8
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
Description	NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.
Time Frame	Baseline (Week 0) to Week 16

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation with multiple imputation to handle missing data due to COVID-19.

Arm/Group Title	Placebo	Risankizumab 180 mg	Risankizumab 360 mg
Arm/Group Description:	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Overall Number of Participants Analyzed	61	61	60
Measure Type: Number; Number (97.5% Confidence Interval); Unit of Measure: percentage of participants
	27.9; (15.0 to 40.7)	31.1; (17.5 to 44.7)	38.6; (24.4 to 52.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 180 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.650
	Comments	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference (%)
	Estimated Value	3.7
	Confidence Interval	(2-Sided) 97.5%; -14.5 to 21.8
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 360 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.147
	Comments	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference (%)
	Estimated Value	12.3
	Confidence Interval	(2-Sided) 97.5%; -6.7 to 31.3
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline
Description	[Not Specified]
Time Frame	Baseline (Week 0) to Week 16

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation.

Arm/Group Title	Placebo	Risankizumab 180 mg	Risankizumab 360 mg
Arm/Group Description:	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Overall Number of Participants Analyzed	82	80	81
Measure Type: Number; Number (97.5% Confidence Interval); Unit of Measure: percentage of participants
	29.3; (18.0 to 40.5)	22.5; (12.0 to 33.0)	18.5; (8.8 to 28.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 180 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.342
	Comments	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference (%)
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 97.5%; -21.8 to 8.8
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 360 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.108
	Comments	Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted Response Rate Difference (%)
	Estimated Value	-10.6
	Confidence Interval	(2-Sided) 97.5%; -25.3 to 4.2
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Description	The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.
Time Frame	Baseline (Week 0) to Week 16

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.

Arm/Group Title	Placebo	Risankizumab 180 mg	Risankizumab 360 mg
Arm/Group Description:	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Overall Number of Participants Analyzed	62	66	63
Least Squares Mean (97.5% Confidence Interval); Unit of Measure: score on a scale
	-2.1; (-3.9 to -0.4)	-3.5; (-5.2 to -1.8)	-3.7; (-5.5 to -2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 180 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.179
	Comments	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.
	Method	mixed-effect model repeat measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.3
	Confidence Interval	(2-Sided) 97.5%; -3.5 to 0.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.97
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 360 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.105
	Comments	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.
	Method	mixed-effect model repeat measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 97.5%; -3.8 to 0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.98
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16
Description	HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Time Frame	Baseline (Week 0) to Week 16

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.

Arm/Group Title	Placebo	Risankizumab 180 mg	Risankizumab 360 mg
Arm/Group Description:	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Overall Number of Participants Analyzed	65	53	63
Least Squares Mean (97.5% Confidence Interval); Unit of Measure: score on a scale
	-0.870; (-1.416 to -0.324)	-0.751; (-1.338 to -0.165)	-0.885; (-1.436 to -0.334)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 180 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.727
	Comments	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.
	Method	mixed-effect model repeat measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.118
	Confidence Interval	(2-Sided) 97.5%; -0.646 to 0.883
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3385
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 360 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.963
	Comments	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.
	Method	mixed-effect model repeat measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.015
	Confidence Interval	(2-Sided) 97.5%; -0.755 to 0.724
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3273
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16
Description	HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Time Frame	Baseline (Week 0) to Week 16

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.

Arm/Group Title	Placebo	Risankizumab 180 mg	Risankizumab 360 mg
Arm/Group Description:	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Overall Number of Participants Analyzed	65	53	63
Least Squares Mean (97.5% Confidence Interval); Unit of Measure: score on a scale
	-0.677; (-1.160 to -0.195)	-0.635; (-1.149 to -0.120)	-0.442; (-0.928 to 0.044)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 180 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.886
	Comments	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.
	Method	mixed-effect model repeat measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.042
	Confidence Interval	(2-Sided) 97.5%; -0.622 to 0.706
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2941
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 360 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.409
	Comments	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.
	Method	mixed-effect model repeat measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.236
	Confidence Interval	(2-Sided) 97.5%; -0.408 to 0.879
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2851
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16
Description	HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Time Frame	Baseline (Week 0) to Week 16

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.

Arm/Group Title	Placebo	Risankizumab 180 mg	Risankizumab 360 mg
Arm/Group Description:	In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Overall Number of Participants Analyzed	65	53	63
Least Squares Mean (97.5% Confidence Interval); Unit of Measure: score on a scale
	-0.630; (-1.154 to -0.107)	-0.882; (-1.440 to -0.324)	-0.705; (-1.233 to -0.176)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 180 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.434
	Comments	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.
	Method	mixed-effect model repeat measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.252
	Confidence Interval	(2-Sided) 97.5%; -0.977 to 0.473
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3212
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Risankizumab 360 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.813
	Comments	Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.
	Method	mixed-effect model repeat measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.074
	Confidence Interval	(2-Sided) 97.5%; -0.779 to 0.631
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3123
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame

From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.

Adverse Event Reporting Description

[Not Specified]

Arm/Group Title

Placebo

Risankizumab 180 mg

Risankizumab 360 mg

Placebo / Risankizumab 360 mg

Risankizumab 180 mg / Risankizumab 360 mg

Risankizumab 360 mg / Risankizumab 360 mg

Arm/Group Description

In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.

In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.

In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.

All-Cause Mortality

Placebo

Risankizumab 180 mg

Risankizumab 360 mg

Placebo / Risankizumab 360 mg

Risankizumab 180 mg / Risankizumab 360 mg

Risankizumab 360 mg / Risankizumab 360 mg

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/82 (0.00%)

0/80 (0.00%)

0/80 (0.00%)

0/74 (0.00%)

0/70 (0.00%)

0/74 (0.00%)

Serious Adverse Events

Placebo

Risankizumab 180 mg

Risankizumab 360 mg

Placebo / Risankizumab 360 mg

Risankizumab 180 mg / Risankizumab 360 mg

Risankizumab 360 mg / Risankizumab 360 mg

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

2/82 (2.44%)

3/80 (3.75%)

2/80 (2.50%)

3/74 (4.05%)

4/70 (5.71%)

0/74 (0.00%)

Cardiac disorders

ANGINA UNSTABLE † 1

1/82 (1.22%)

1

0/80 (0.00%)

0

0/80 (0.00%)

0

0/74 (0.00%)

0

0/70 (0.00%)

0

0/74 (0.00%)

0

Gastrointestinal disorders

SMALL INTESTINAL OBSTRUCTION † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

1/80 (1.25%)

1

0/74 (0.00%)

0

1/70 (1.43%)

1

0/74 (0.00%)

0

Infections and infestations

APPENDICITIS † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

0/80 (0.00%)

0

1/74 (1.35%)

1

0/70 (0.00%)

0

0/74 (0.00%)

0

COVID-19 PNEUMONIA † 1

0/82 (0.00%)

0

1/80 (1.25%)

1

0/80 (0.00%)

0

0/74 (0.00%)

0

0/70 (0.00%)

0

0/74 (0.00%)

0

CELLULITIS † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

0/80 (0.00%)

0

1/74 (1.35%)

1

0/70 (0.00%)

0

0/74 (0.00%)

0

SUBCUTANEOUS ABSCESS † 1

0/82 (0.00%)

0

1/80 (1.25%)

1

0/80 (0.00%)

0

0/74 (0.00%)

0

0/70 (0.00%)

0

0/74 (0.00%)

0

TONSILLITIS † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

0/80 (0.00%)

0

0/74 (0.00%)

0

1/70 (1.43%)

1

0/74 (0.00%)

0

URINARY TRACT INFECTION † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

0/80 (0.00%)

0

0/74 (0.00%)

0

1/70 (1.43%)

1

0/74 (0.00%)

0

Musculoskeletal and connective tissue disorders

INTERVERTEBRAL DISC PROTRUSION † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

0/80 (0.00%)

0

0/74 (0.00%)

0

1/70 (1.43%)

1

0/74 (0.00%)

0

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

BREAST CANCER † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

0/80 (0.00%)

0

1/74 (1.35%)

1

0/70 (0.00%)

0

0/74 (0.00%)

0

Psychiatric disorders

AFFECTIVE DISORDER † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

1/80 (1.25%)

1

0/74 (0.00%)

0

0/70 (0.00%)

0

0/74 (0.00%)

0

INTENTIONAL SELF-INJURY † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

1/80 (1.25%)

1

0/74 (0.00%)

0

0/70 (0.00%)

0

0/74 (0.00%)

0

MAJOR DEPRESSION † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

1/80 (1.25%)

1

0/74 (0.00%)

0

0/70 (0.00%)

0

0/74 (0.00%)

0

SUICIDAL IDEATION † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

1/80 (1.25%)

1

0/74 (0.00%)

0

0/70 (0.00%)

0

0/74 (0.00%)

0

Reproductive system and breast disorders

ENDOMETRIOSIS † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

0/80 (0.00%)

0

1/74 (1.35%)

1

0/70 (0.00%)

0

0/74 (0.00%)

0

OVARIAN CYST † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

0/80 (0.00%)

0

1/74 (1.35%)

1

0/70 (0.00%)

0

0/74 (0.00%)

0

Skin and subcutaneous tissue disorders

HIDRADENITIS † 1

1/82 (1.22%)

1

0/80 (0.00%)

0

0/80 (0.00%)

0

0/74 (0.00%)

0

0/70 (0.00%)

0

0/74 (0.00%)

0

Surgical and medical procedures

ABORTION INDUCED † 1

0/82 (0.00%)

0

1/80 (1.25%)

1

0/80 (0.00%)

0

0/74 (0.00%)

0

0/70 (0.00%)

0

0/74 (0.00%)

0

Vascular disorders

DEEP VEIN THROMBOSIS † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

0/80 (0.00%)

0

0/74 (0.00%)

0

1/70 (1.43%)

1

0/74 (0.00%)

0

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

5%

Placebo

Risankizumab 180 mg

Risankizumab 360 mg

Placebo / Risankizumab 360 mg

Risankizumab 180 mg / Risankizumab 360 mg

Risankizumab 360 mg / Risankizumab 360 mg

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

19/82 (23.17%)

21/80 (26.25%)

26/80 (32.50%)

26/74 (35.14%)

12/70 (17.14%)

19/74 (25.68%)

Gastrointestinal disorders

DIARRHOEA † 1

4/82 (4.88%)

4

2/80 (2.50%)

2

2/80 (2.50%)

4

5/74 (6.76%)

5

1/70 (1.43%)

1

2/74 (2.70%)

2

Infections and infestations

NASOPHARYNGITIS † 1

3/82 (3.66%)

3

6/80 (7.50%)

6

7/80 (8.75%)

8

1/74 (1.35%)

1

4/70 (5.71%)

5

1/74 (1.35%)

1

UPPER RESPIRATORY TRACT INFECTION † 1

1/82 (1.22%)

1

1/80 (1.25%)

1

4/80 (5.00%)

4

2/74 (2.70%)

2

0/70 (0.00%)

0

0/74 (0.00%)

0

URINARY TRACT INFECTION † 1

1/82 (1.22%)

1

4/80 (5.00%)

4

3/80 (3.75%)

3

4/74 (5.41%)

4

0/70 (0.00%)

0

0/74 (0.00%)

0

Musculoskeletal and connective tissue disorders

BACK PAIN † 1

2/82 (2.44%)

2

3/80 (3.75%)

3

4/80 (5.00%)

4

2/74 (2.70%)

2

0/70 (0.00%)

0

1/74 (1.35%)

1

Nervous system disorders

HEADACHE † 1

9/82 (10.98%)

16

6/80 (7.50%)

6

11/80 (13.75%)

15

7/74 (9.46%)

10

1/70 (1.43%)

1

4/74 (5.41%)

5

Skin and subcutaneous tissue disorders

ECZEMA † 1

0/82 (0.00%)

0

0/80 (0.00%)

0

2/80 (2.50%)

2

1/74 (1.35%)

1

0/70 (0.00%)

0

4/74 (5.41%)

4

HIDRADENITIS † 1

7/82 (8.54%)

7

3/80 (3.75%)

3

2/80 (2.50%)

3

6/74 (8.11%)

6

8/70 (11.43%)

8

10/74 (13.51%)

10

1 Term from vocabulary, MedDRA 24.0; † 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: NCT03926169
• Other Study ID Numbers: M16-833; 2019-000122-21 ( EudraCT Number )
• First Submitted: April 23, 2019
• First Posted: April 24, 2019
• Results First Submitted: July 14, 2022
• Results First Posted: August 11, 2022
• Last Update Posted: August 11, 2022