Recruiting
Phase 2
Phase 3

Brepocitinib

Sponsor:

Priovant Therapeutics, Inc.

Code:

NCT06978725

Conditions

Cutaneous Sarcoidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral Brepocitinib

Oral Placebo

Study Details

Brief summary:

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

Conditions

Cutaneous Sarcoidosis

Study ID

NCT06978725

Start date

Apr 9, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Oral Brepocitinib

Oral Brepocitinib

Oral Placebo

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 ]
  • Part 2: Proportion of participants achieving a reduction in Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) from baseline to Week 16. [ Time Frame: 16 Weeks ]

Central Contacts and Locations

Central contacts

Clinical Trial Administrator

(212) 634-9743clinicaltrials@priovant.com

Locations

Clinical Trial Site

Recruiting

Birmingham, Alabama, United States, 27516

Clinical Trial Site

Recruiting

Phoenix, Arizona, United States, 85054

Clinical Trial Site

Recruiting

Tucson, Arizona, United States, 85718

Clinical Trial Site

Recruiting

San Francisco, California, United States, 94115

Clinical Trial Site

Recruiting

New Haven, Connecticut, United States, 06519

Clinical Trial Site

Recruiting

Washington D.C., District of Columbia, United States, 10060

Clinical Trial Site

Recruiting

Atlanta, Georgia, United States, 30322

Clinical Trial Site

Recruiting

Sandy Springs, Georgia, United States, 30328

Clinical Trial Site

Recruiting

Chicago, Illinois, United States, 60612

Clinical Trial Site

Recruiting

Chicago, Illinois, United States, 60637

Clinical Trial Site

Recruiting

Kansas City, Kansas, United States, 66160

Clinical Trial Site

Recruiting

Louisville, Kentucky, United States, 40241

Clinical Trial Site

Recruiting

New Orleans, Louisiana, United States, 41076

Clinical Trial Site

Recruiting

Baltimore, Maryland, United States, 21201

Clinical Trial Site

Recruiting

Boston, Massachusetts, United States, 02115

Clinical Trial Site

Recruiting

Ann Arbor, Michigan, United States, 48103

Clinical Trial Site

Recruiting

Ann Arbor, Michigan, United States, 48109

Clinical Trial Site

Recruiting

Troy, Michigan, United States, 48084

Clinical Trial Site

Recruiting

St Louis, Missouri, United States, 63110

Clinical Trial Site

Recruiting

Lebanon, New Hampshire, United States, 03766

Clinical Trial Site

Recruiting

Brooklyn, New York, United States, 11203

Clinical Trial Site

Recruiting

Lake Success, New York, United States, 11042

Clinical Trial Site

Recruiting

New York, New York, United States, 10016

Clinical Trial Site

Recruiting

New York, New York, United States, 10029

Clinical Trial Site

Recruiting

Rochester, New York, United States, 14620

Clinical Trial Site

Recruiting

Chapel Hill, North Carolina, United States, 27516

Clinical Trial Site

Recruiting

Durham, North Carolina, United States, 27703

Clinical Trial Site

Recruiting

Greenville, North Carolina, United States, 27834

Clinical Trial Site

Recruiting

Cleveland, Ohio, United States, 44195

Clinical Trial Site

Recruiting

Fairborn, Ohio, United States, 45324

Clinical Trial Site

Recruiting

Hershey, Pennsylvania, United States, 17033

Clinical Trial Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Clinical Trial Site

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Clinical Trial Site

Recruiting

Charleston, South Carolina, United States, 29425

Clinical Trial Site

Recruiting

Houston, Texas, United States, 77030

Clinical Trial Site

Recruiting

Norfolk, Virginia, United States, 23502

Clinical Trial Site

Recruiting

Richmond, Virginia, United States, 23219

Clinical Trial Site

Recruiting

Madison, Wisconsin, United States, 53715

Clinical Trial Site

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Priovant Therapeutics, Inc.

Last update posted

Oct 21, 2026

Last verified

Aug, 2026

Keywords

  • sarcoidosis
  • cutaneous sarcoidosis
  • brepocitinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Priovant Therapeutics, Inc. on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.