A Phase 2 Study of the Safety and Efficacy of Brepocitinib in Adults With Cutaneous Sarcoidosis (BEACON)
BEACON
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Cutaneous Sarcoidosis
1 other identifier
interventional
28
1 country
4
Brief Summary
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2025
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2025
CompletedFirst Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 18, 2025
May 1, 2025
1.6 years
April 30, 2025
May 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score through Week 16.
16 Weeks
Study Arms (3)
Brepocitinib Dose Level 1
EXPERIMENTALBrepocitinib Dose Level 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adults subjects (18-74)
- Cutaneous sarcoidosis with characteristic skin biopsy histology
- A CSAMI activity score ≥ 10
- Weight \> 40 kg to \< 130 kg with BMI \< 40 kg/m2 .
You may not qualify if:
- 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).
- High risk of thrombosis or cardiovascular disease
- High risk of herpes zoster
- Active or recent infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Clinical Trial Site
San Francisco, California, 94115, United States
Clinical Trial Site
Durham, North Carolina, 27703, United States
Clinical Trial Site
Philadelphia, Pennsylvania, 19104, United States
Clinical Trial Site
Madison, Wisconsin, 53715, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 18, 2025
Record last verified: 2025-05