Last updated on July 2018

A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Brief description of study

Primary end point: To evaluate the safety and tolerability of INCB054707.

Secondary end point: To evaluate the systemic exposure and evaluate the efficacy of INCB054707.

Overall design: This is a Phase 2, multicenter, open-label, single-arm study to assess the safety of 15 mg QD INCB054707 over 8 weeks in men and women aged 18 to 75 years with moderate to severe HS with a targeted enrollment of up to 10 participants.

Safety assessments include monitoring of AEs, clinical laboratory tests, vital signs, ECGs, and physical examinations.

Efficacy assessments include HiSCR as assessed by the AN count, HS Pain NRS, modified Sartorius scale, draining fistula count, and need for rescue lesional treatment. Quality of life will be assessed using the DLQI (participant-reported). Exploratory assessments include the IHS4 and HiSQoL. Pharmacokinetic assessments include plasma concentrations for determination of PK parameters, and translational assessments include biomarker levels, adhesive skin strips, and skin biopsies at selected study sites. Medical photographs of a target lesion will be taken at selected anatomic sites to illustrate the outcome of the study.

Clinical Study Identifier: TX207693

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Located in: Tampa, FL USA
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Located in: Hershey, PA USA
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Located in: New York, NY USA
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Located in: Los Angeles, CA USA
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Recruitment Status: Open

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