Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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. All eligible participants will be invited to continue treatment
for an additional 48-week Long-term extension period (also open label).
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Skin Lesions
Enrollment Eligibility
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.