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Recruiting Phase 2/3

A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis

NCT06978725 · tracked via the Priya Life Science UK tracker
Phase
Phase 2/3
Started
2025-04-09
Last updated
2026-10-21

Condition(s) studied

Cutaneous Sarcoidosis

Investigational drug(s) / intervention(s)

Oral Brepocitinib →Oral Placebo

Oral Brepocitinib: Oral Brepocitinib

Oral Placebo: Placebo

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adults subjects 2. Cutaneous sarcoidosis with characteristic skin biopsy histology 3. A CSAMI activity score ≥ 10 4. Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) ≤ 45 kg/m2. Exclusion Criteria 1. History of cancer, with the exception of the following cancers with documentation of complete resection and no evidence of recurrence for ≥ 1 year: basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix. 2. High risk of thrombosis or cardiovascular disease 3. High risk of herpes zoster 4. Active or recent infection

Primary outcome measure(s)

  • Part 1: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0 — Week 16
  • Part 2: Proportion of participants achieving a reduction in Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) from baseline to Week 16. — 16 Weeks

Trial sites (39)

FacilityCityRegionStatus
Clinical Trial Site Birmingham Alabama Recruiting
Clinical Trial Site Phoenix Arizona Recruiting
Clinical Trial Site Tucson Arizona Recruiting
Clinical Trial Site San Francisco California Recruiting
Clinical Trial Site New Haven Connecticut Recruiting
Clinical Trial Site Washington D.C. District of Columbia Recruiting
Clinical Trial Site Atlanta Georgia Recruiting
Clinical Trial Site Sandy Springs Georgia Recruiting
Clinical Trial Site Chicago Illinois Recruiting
Clinical Trial Site Chicago Illinois Recruiting
Clinical Trial Site Kansas City Kansas Recruiting
Clinical Trial Site Louisville Kentucky Recruiting
Clinical Trial Site New Orleans Louisiana Recruiting
Clinical Trial Site Baltimore Maryland Recruiting
Clinical Trial Site Boston Massachusetts Recruiting
Clinical Trial Site Ann Arbor Michigan Recruiting
Clinical Trial Site Ann Arbor Michigan Recruiting
Clinical Trial Site Troy Michigan Recruiting
Clinical Trial Site St Louis Missouri Recruiting
Clinical Trial Site Lebanon New Hampshire Recruiting
Clinical Trial Site Brooklyn New York Recruiting
Clinical Trial Site Lake Success New York Recruiting
Clinical Trial Site New York New York Recruiting
Clinical Trial Site New York New York Recruiting
Clinical Trial Site Rochester New York Recruiting
Clinical Trial Site Chapel Hill North Carolina Recruiting
Clinical Trial Site Durham North Carolina Recruiting
Clinical Trial Site Greenville North Carolina Recruiting
Clinical Trial Site Cleveland Ohio Recruiting
Clinical Trial Site Fairborn Ohio Recruiting
Clinical Trial Site Hershey Pennsylvania Recruiting
Clinical Trial Site Philadelphia Pennsylvania Recruiting
Clinical Trial Site Philadelphia Pennsylvania Recruiting
Clinical Trial Site Charleston South Carolina Recruiting
Clinical Trial Site Houston Texas Recruiting
Clinical Trial Site Norfolk Virginia Recruiting
Clinical Trial Site Richmond Virginia Recruiting
Clinical Trial Site Madison Wisconsin Recruiting
Clinical Trial Site Milwaukee Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06978725 on ClinicalTrials.gov ↗ ← All trials in the UK