Status:

COMPLETED

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

Lead Sponsor:

Incyte Corporation

Conditions:

Hidradenitis Suppurativa

Acne Inversa

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief 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. Al...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 25 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 16 2023

Estimated Enrollment :

209 Patients enrolled

Trial Details

Trial ID

NCT04476043

Start Date

August 25 2020

End Date

August 16 2023

Last Update

August 12 2025

Active Locations (40)

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Page 1 of 10 (40 locations)

1

Investigative Site 005

Hoover, Alabama, United States, 35244

2

Investigative Site 003

Gilbert, Arizona, United States, 85295

3

Investigative Site 011

Phoenix, Arizona, United States, 85006

4

Investigative Site 014

Fountain Valley, California, United States, 92708

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