Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Triple

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
INCB054707 Dose A
Participants will receive INCB054707 Dose A for 16 weeks (Period 1) followed by INCB054707 Dose C for 36 weeks (Period 2).
  • Drug: INCB054707
    Oral; Tablet
Experimental
INCB054707 Dose B
Participants will receive INCB054707 Dose B for 16 weeks (Period 1) followed by INCB054707 Dose C for 36 weeks (Period 2).
  • Drug: INCB054707
    Oral; Tablet
Experimental
INCB054707 Dose C
Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2)
  • Drug: INCB054707
    Oral; Tablet
  • Drug: Placebo
    Oral; Tablet
Placebo Comparator
Placebo followed by INCB054707 Dose C
Participants will receive placebo for 16 weeks (Period 1) followed by INCB054707 Dose C for 36 weeks (Period 2).
  • Drug: Placebo
    Oral; Tablet

Recruiting Locations

Tulane University Health Sciences Center
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.