INCB 54707-302
Research type
Research Study
Full title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
IRAS ID
1007429
Contact name
Habib Zalila
Contact email
Sponsor organisation
Incyte Corporation
Clinicaltrials.gov Identifier
Research summary
INCB054707 (or povorcitinib) is an investigational drug that is being studied by Incyte Corporation (“Sponsor”) for use in the treatment of Hidradenitis Suppurativa (HS). HS is a skin condition that causes painful lumps under the skin in places like the armpits, groin, and buttocks.
The Study has different parts, or periods: A 28 day Screening Period to determine if the participants are suitable for the study, a placebo-controlled period an extension period and a safety follow-up period to continue checking the participants health and effect of the study drug after they stop taking it. Over the 62 weeks of this Study (about 14 months), participants will be expected to make about 15 visits to the Study Site.
Approximately 600 participants (18 years and older) with moderate to severe HS will be randomly assigned (by chance) to povorcitinib (45 or 75 mg once daily) or placebo (tablets that look the same as the study drug but contains no active medication) once daily for 12 weeks. This part of the study is called the placebo-controlled period. The Placebo-Controlled Period is “double-blind,” which means that during this Period, the participant and their Study Doctor will not know which Study Drug the participants are receiving (INCB054707 or placebo). Participants that complete the placebo-controlled period will be offered the possibility to continue in a 42-week double-blind extension period with povorcitinib 45 mg or 75 mg once daily. During this time, all participants will receive INCB054707, even if they received placebo previously in the Placebo-Controlled Period.
This is a global study and will take approximately 3.5 years to complete.REC name
Wales REC 5
REC reference
23/WA/0089
Date of REC Opinion
16 Aug 2023
REC opinion
Further Information Favourable Opinion