To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

• Status: Active, not recruiting
• Trial end date: 2022-09-26
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36 -week open-label extension period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• HS disease duration of at least 3 months before screening.

• Willingness to avoid pregnancy or fathering children.

• Active HS in at least 2 distinct anatomical areas.

• Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period

Exclusion Criteria:

• Draining fistula count of > 20 at screening or baseline.

• Women who are pregnant (or who are considering pregnancy) or lactating.

• 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.

• History of failure to treatment of inflammatory diseases with JAK inhibitors.

• Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.

• Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.

• Laboratory values outside of the protocol-defined ranges.