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

San Francisco, California, United States, 94115

Clinical Trial Site

Recruiting

Durham, North Carolina, United States, 27703

Clinical Trial Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Clinical Trial Site

Recruiting

Madison, Wisconsin, United States, 53715

More Information

Sponsor

Priovant Therapeutics, Inc.

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • sarcoidosis
  • cutaneous sarcoidosis
  • brepocitinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Priovant Therapeutics, Inc. on 2026-08-27.