A Phase 2 Study of the Safety and Efficacy of Brepocitinib in Adults With Cutaneous Sarcoidosis (BEACON)

Phase 2

Recruiting

• Conditions: Cutaneous Sarcoidosis
• Interventions: Drug: Oral Brepocitinib; Drug: Oral Placebo

• Registration Number: NCT06978725
• Lead Sponsor: Priovant Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-09
• Study First Submitted: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Adults subjects (18-74)
2. Cutaneous sarcoidosis with characteristic skin biopsy histology
3. A CSAMI activity score ≥ 10
4. Weight > 40 kg to < 130 kg with BMI < 40 kg/m2 .

Exclusion Criteria

1. History of

   • Lymphoproliferative disorder
   • Active malignancy;
   • History of cancer within 5 years prior to baseline (exceptions for 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brepocitinib Dose Level 1	Oral Brepocitinib	-
Brepocitinib Dose Level 2	Oral Brepocitinib	-
Placebo	Oral Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0	Screening up to 28 days after the last dose of study drug at 16 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score through Week 16.	16 Weeks	CSAMI-A score is a measure of cutaneous sarcoidosis disease activity. A higher score indicates worse disease. Scores range from 0-165.

Trial Locations

Locations (1)

Clinical Trial Site; 🇺🇸 Madison, Wisconsin, United States