NL-OMON50087
Completed
Phase 2
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. - M16-833
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AbbVie B.V.
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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