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

Incyte

Status and phase: Completed; Phase 2

Conditions: Acne Inversa; Hidradenitis Suppurativa

Treatments: Drug: INCB054707; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04476043

INCB 54707-204

Details and patient eligibility

About

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).

Enrollment: 209 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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209 participants in 4 patient groups, including a placebo group

INCB054707 15 mg

Experimental group

Description:

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.

Treatment:

Drug: INCB054707

INCB054707 45 mg

Experimental group

Description:

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.

Treatment:

Drug: INCB054707

INCB054707 75 mg

Experimental group

Description:

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.

Treatment:

Drug: INCB054707

Placebo followed by INCB054707 75 mg

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo