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

Recruiting at 40 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Must not be taking: JAK inhibitors

Disqualifiers: Pregnancy, Cancer, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

209 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What is the purpose of this trial?

This trial is testing a new medication called INCB054707 to help people with hidradenitis suppurativa, a painful skin condition. The study will first compare the medication to an inactive substance for a few months, then allow all participants to use the medication for several more months. If effective, participants can continue using it for an extended period.

Eligibility Criteria

Inclusion Criteria

You have been experiencing symptoms of HS disease for at least 3 months before the screening.

HS disease duration of at least 3 months before screening

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

Exclusion Criteria

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

You have tried using JAK inhibitors before to treat inflammatory diseases, but they didn't work for you.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB054707 or placebo for 16 weeks in a placebo-controlled treatment period

16 weeks

Visits at Weeks 2, 4, 6, 8, 12, and 16

Open-label Extension

Participants receive INCB054707 75 mg for 36 weeks

36 weeks

Long-term Extension

Participants may opt into continuation of open-label treatment for an additional 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• INCB054707

Participant Groups

Group I: INCB054707 75 mg Experimental Treatment 1 Intervention

Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks.

Group II: INCB054707 45 mg Experimental Treatment 1 Intervention

Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.

Group III: INCB054707 15 mg Experimental Treatment 1 Intervention

Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.

Group IV: Placebo followed by INCB054707 75 mg Placebo Group 1 Intervention

Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School