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

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. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).

Conditions

  • Hidradenitis Suppurativa
  • Acne Inversa

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 15 mg 		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.
  • Drug: INCB054707
    Oral; Tablet
    Other names:
    • Povorcitinib
Experimental
INCB054707 45 mg 		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.
  • Drug: INCB054707
    Oral; Tablet
    Other names:
    • Povorcitinib
Experimental
INCB054707 75 mg 		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.
  • Drug: INCB054707
    Oral; Tablet
    Other names:
    • Povorcitinib
  • Drug: Placebo
    Oral; Tablet
Placebo Comparator
Placebo followed by INCB054707 75 mg 		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.
  • Drug: Placebo
    Oral; Tablet

More Details

Status
Completed
Sponsor
Incyte Corporation

Study Contact