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 Supperativa.
- Conditions
- Acne InversaInfected Sweat Glands1000381610040792
- Registration Number
- NL-OMON50087
- Lead Sponsor
- AbbVie B.V.
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
• Subjects must be >= 18 years old at Screening with a clinical diagnosis
of moderate to severe HS (defined as a total AN count of >= 5 at Baseline,
presence of HS lesions in at least 2 distinct anatomic areas, and draining
fistula count of <= 20 at Baseline) for at least 1 year prior to Baseline, as
determined by the investigator (i.e., through medical history, interview
of subject).
• Subjects must have a history of inadequate response or intolerance to
an adequate trial of oral antibiotics for treatment of HS.
• Prior exposure to anti-IL12/23/17 (overall, no more than 10% of the
study population)
• Prior exposure to anti-TNF (overall, no more than 15% of the study
population)
No history of active skin disease other than HS that could interfere with
the assessment of HS.
No active TB or concurrent treatment for latent TB and no evidence of
HBV, HCV or HIV.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the proportion of subjects achieving Hidradenitis<br /><br>Suppurativa Clinical Response (HiSCR) at Week 16. HiSCR is defined as at least<br /><br>a 50% reduction in the total inflammatory nodule [AN] count with no increase in<br /><br>abscess count and no increase in draining fistula count relative to baseline. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Proportion of subjects achieving at least 30% reduction and at least 1 unit<br /><br>reduction from Baseline in NRS30 in PGA Skin Pain at Week 8 among subjects with<br /><br>Baseline Numerical Rating Scale (NRS) >= 3.<br /><br>Proportion of subjects achieving NRS30 in PGA Skin Pain at Week 16 among<br /><br>subjects with Baseline NRS >= 3.<br /><br>Proportion of subjects who experience at least 25% increase in AN counts with a<br /><br>minimum increase of 2 relative to Baseline during Period A.<br /><br>Change from Baseline in DLQI at Week 16.<br /><br>Change from Baseline in HS-related swelling - assessed based on the<br /><br>HSSA at Week 16.<br /><br>Change from Baseline in HS-related odor - assessed based on the HSSA<br /><br>at Week 16.<br /><br>Change from Baseline in HS-related worst drainage - assessed based on<br /><br>the HSSA at Week 16.</p><br>