A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Study Overview
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Brief Summary
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The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.

Official Title
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A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Risankizumab
* Drug: Placebo for risankizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant with moderate to severe HS for at least 1 year prior to baseline visit. HS lesions present in at least two distinct anatomical areas. Draining fistula count of ≤ 20 at Baseline visit. Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit. Participants are required to use a daily antiseptic wash on their HS lesions. Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS. Exclusion Criteria: Participant has a history of active skin disease other than HS that could interfere with the assessment of HS. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline. Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit. Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit. Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risankizumab 180 mg<br>In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12. | Drug: Risankizumab<br>* Risankizumab is administered as a SC injection in pre-filled syringe (PFS)<br>* Other names: SKYRIZI;|
| Experimental: Risankizumab 360 mg<br>In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. | Drug: Risankizumab<br>* Risankizumab is administered as a SC injection in pre-filled syringe (PFS)<br>* Other names: SKYRIZI;|
| Placebo Comparator: Placebo<br>In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. | Drug: Placebo for risankizumab<br>* Placebo for risankizumab is administered as a SC injection in PFS<br>|
| Experimental: Risankizumab 180 mg / Risankizumab 360 mg<br>In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60. | Drug: Risankizumab<br>* Risankizumab is administered as a SC injection in pre-filled syringe (PFS)<br>* Other names: SKYRIZI;Drug: Placebo for risankizumab<br>* Placebo for risankizumab is administered as a SC injection in PFS<br>|
| Experimental: Risankizumab 360 mg / Risankizumab 360 mg<br>In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60. | Drug: Risankizumab<br>* Risankizumab is administered as a SC injection in pre-filled syringe (PFS)<br>* Other names: SKYRIZI;Drug: Placebo for risankizumab<br>* Placebo for risankizumab is administered as a SC injection in PFS<br>|
| Placebo Comparator: Placebo / Risankizumab 360 mg<br>In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60. | Drug: Risankizumab<br>* Risankizumab is administered as a SC injection in pre-filled syringe (PFS)<br>* Other names: SKYRIZI;Drug: Placebo for risankizumab<br>* Placebo for risankizumab is administered as a SC injection in PFS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 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. | Baseline (Week 0), Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Baseline (Week 0) to Week 8 | 
| 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 | 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. | Baseline (Week 0) to Week 16 | 
| 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 |  | Baseline (Week 0) to Week 16 | 
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | 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. | Baseline (Week 0) to Week 16 | 
| Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16 | 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. | Baseline (Week 0) to Week 16 | 
| Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16 | 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. | Baseline (Week 0) to Week 16 | 
| Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16 | 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. | Baseline (Week 0) to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hidradenitis Suppurativa, Risankizumab, Placebo