A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis

NCT06978725 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PVT-2201-203
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Cutaneous Sarcoidosis

Keywords

sarcoidosis; cutaneous sarcoidosis; brepocitinib

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Part 1: Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score

  16 Weeks

• Part 2: Proportion of participants achieving a low Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score

  16 weeks

Study Arms (5)

Part 1: Brepocitinib Dose Level 1

EXPERIMENTAL

Oral Brepocitinib

Drug: Oral Brepocitinib

Part 1: Brepocitinib Dose Level 2

EXPERIMENTAL

Oral Brepocitinib

Drug: Oral Brepocitinib

Part 1: Placebo

PLACEBO COMPARATOR

Drug: Oral Placebo

Part 2: Brepocitinib Dose Level 1

EXPERIMENTAL

Oral Brepocitinib

Drug: Oral Brepocitinib

Part 2: Placebo

PLACEBO COMPARATOR

Drug: Oral Placebo

Interventions

Oral Brepocitinib DRUG

Oral Brepocitinib

Part 1: Brepocitinib Dose Level 1; Part 1: Brepocitinib Dose Level 2; Part 2: Brepocitinib Dose Level 1

Oral Placebo DRUG

Placebo

Part 1: Placebo; Part 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults subjects
• Cutaneous sarcoidosis with characteristic skin biopsy histology
• A CSAMI activity score ≥ 10
• Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) ≤ 45 kg/m2.

You may not qualify if:

• 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.
• High risk of thrombosis or cardiovascular disease
• High risk of herpes zoster
• Active or recent infection

Sponsors & Collaborators

• Priovant Therapeutics, Inc.: lead

Study Sites (4)

Clinical Trial Site

San Francisco, California, 94115, United States

RECRUITING

Clinical Trial Site

Durham, North Carolina, 27703, United States

RECRUITING

Clinical Trial Site

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Clinical Trial Site

Madison, Wisconsin, 53715, United States

RECRUITING

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Central Study Contacts

Clinical Trial Administrator

CONTACT

(212) 634-9743; clinicaltrials@priovant.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 18, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)