A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Registration Number
- NCT03926169
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risankizumab 180 mg Risankizumab In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12. Risankizumab 360 mg Risankizumab In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. Placebo Placebo for risankizumab In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. Risankizumab 180 mg / Risankizumab 360 mg Placebo for risankizumab 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. Risankizumab 360 mg / Risankizumab 360 mg Placebo for risankizumab 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. Placebo / Risankizumab 360 mg Placebo for risankizumab 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. Risankizumab 180 mg / Risankizumab 360 mg Risankizumab 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. Risankizumab 360 mg / Risankizumab 360 mg Risankizumab 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. Placebo / Risankizumab 360 mg Risankizumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 Baseline (Week 0), 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16 Baseline (Week 0) to 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.
Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16 Baseline (Week 0) to 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 Baseline (Week 0) to 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.
Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16 Baseline (Week 0) to 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.
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 Baseline (Week 0) to Week 8 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.
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 Baseline (Week 0) to Week 16 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.
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (59)
Burke Pharmaceutical Research /ID# 211671
🇺🇸Hot Springs, Arkansas, United States
Bakersfield Derma & Skin Cance /ID# 211684
🇺🇸Bakersfield, California, United States
Wallace Medical Group /ID# 215958
🇺🇸Los Angeles, California, United States
Integrative Skin Science and Research /ID# 212550
🇺🇸Sacramento, California, United States
UC Davis Health /ID# 211436
🇺🇸Sacramento, California, United States
California Dermatology Institute /ID# 211786
🇺🇸Thousand Oaks, California, United States
CCD Research, PLLC /ID# 214479
🇺🇸Cromwell, Connecticut, United States
Advanced Medical Research /ID# 215203
🇺🇸Sandy Springs, Georgia, United States
Arlington Dermatology /ID# 219096
🇺🇸Rolling Meadows, Illinois, United States
Tufts Medical Center /ID# 212680
🇺🇸Boston, Massachusetts, United States
Scroll for more (49 remaining)Burke Pharmaceutical Research /ID# 211671🇺🇸Hot Springs, Arkansas, United States