A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

Launched by INCYTE CORPORATION · Nov 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Povorcitinib (INCB054707) to see how well it works and how safe it is for people with moderate to severe Hidradenitis Suppurativa (HS), a skin condition that causes painful bumps and abscesses. The study will last for a total of 54 weeks, starting with a 12-week period where some participants will receive the medication and others will receive a placebo (a dummy treatment that looks like the real thing but has no active ingredients). After this, everyone will continue in the study for an additional 42 weeks.

To join the trial, participants need to have had moderate to severe HS for at least three months and have a specific number of abscesses and nodules. They should also have already tried at least one other treatment for HS without enough improvement. Participants must agree to not use certain treatments during the study and will need to follow specific guidelines provided by the researchers. This trial is currently recruiting people of all genders aged 18 and older. It’s important for anyone considering participation to talk with their healthcare provider to understand if this study is the right fit for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
• • Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits
• • HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits
• • Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
• • Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
• • Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
• • Agreement to use contraception
• • Willing and able to comply with the study protocol and procedures.
• • Further inclusion criteria apply.
• Exclusion Criteria:
• • Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit.
• • Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
• • Laboratory values outside of the protocol-defined ranges.
• • Further exclusion criteria apply.