A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis

Conditions

• Cutaneous Sarcoidosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Oral Brepocitinib — DRUG
  Oral Brepocitinib
• Oral Placebo — DRUG
  Placebo

Study Details

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.

Key Dates

First listed

May 18, 2025

Start date

Apr 9, 2025

Status verified

Aug 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2029

Study Design

Enrollment

168 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Brepocitinib Dose Level 1
  Oral Brepocitinib
• Experimental: Part 1: Brepocitinib Dose Level 2
  Oral Brepocitinib
• Placebo Comparator: Part 1: Placebo
• Experimental: Part 2: Brepocitinib Dose Level 1
  Oral Brepocitinib
• Placebo Comparator: Part 2: Placebo

Primary Outcome Measure

Part 1: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0 [ Time Frame: Week 16 ]

Central Contacts

• Clinical Trial Administrator
  (212) 634-9743
  [email protected]

Locations (4)

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