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

Janssen-Cilag International NV0 sites180 target enrollmentDecember 11, 2018

Overview

No summary available.

Registry

who.int

Start Date

December 11, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 162
•F.1\.3 Elderly (\>\=65 years) yes

•\-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 prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
•\-Receipt of systemic non\-biologic therapies for the treatment of HS \<4 weeks prior to 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.