NL-OMON46316
Completed
Phase 2
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa - NOVA
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- chronical pain
- Sponsor
- Janssen-Cilag
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Be a man or a woman at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
- •\-Have moderate to severe HS for at least 1 year (365 days) prior to the baseline visit.
- •\-Have HS lesions present in at least 2 distinct anatomic areas.
- •\-Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS.
- •\-Have stable HS for at least 1 month (28 days) prior to the screening visit.
- •\-Have a total abscess and inflammatory nodule (AN) count of \*3 at the screening and baseline visit.
- •\-Must agree to daily use of one of the following over\-the\-counter treatments to the body areas affected with HS lesions: either soap and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan, or benzoyl peroxide, or a dilute bleach bath.
- •\-Before randomization, a woman must be either:
- •a. not of childbearing potential;
- •b. of childbearing potential and practicing a highly effective method of birth control.
Exclusion Criteria
- •\-Has previously received guselkumab.
- •\-Any other active skin disease or condition that could have interfered with assessment of HS.
- •\-Has a draining fistula count of \>20 at the baseline visit.
- •\-Receipt of immunomodulatory biologic therapies (eg monoclonal antibodies) within 3 months or 5 half\-lives prior to the baseline visit, whichever is longer.
- •\-Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 weeks prior to the baseline visit.
- •\-Receipt of systemic non\-biologic therapies for the treatment of HS \<4 weeks prior to the baseline visit.
- •\-Has received any therapeutic agent directly targeted to IL\-17 or IL\-23 within 6 months of the first administration of study intervention (including but not limited to ustekinumab, tildrakizumab, risankizumab, secukinumab, ixekizumab, or brodalumab).
- •\-Has received natalizumab, belimumab, or agents that modulate B cells or T cells (eg, rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study intervention.
- •\-Has received any systemic immunosuppressants (eg, methotrexate, azathioprine, cyclosporine, 6\-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus) or anakinra within 4 weeks of the first administration of study intervention.
- •\-Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
Outcomes
Primary Outcomes
Not specified
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