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Recruiting NCT06978725

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

Phase II Interventional Cutaneous Sarcoidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Brepocitinib, Oral Placebo.
Who it may be relevant to
Registry conditions: Cutaneous Sarcoidosis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Oral Brepocitinib
    Drug: Oral Brepocitinib
  • Drug Oral Placebo
    Drug: Oral Placebo

Primary outcome measures

  • Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0 [Time frame: Screening up to 28 days after the last dose of study drug at 16 weeks]
Secondary outcome measures (1)
  • Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score through Week 16. [Time frame: 16 Weeks]

Eligibility criteria

Inclusion criteria

  • 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 .

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Clinical Trial Site — San Francisco
  • Clinical Trial Site — Durham
  • Clinical Trial Site — Philadelphia
  • Clinical Trial Site — Madison

Identifiers

NCT: NCT06978725 · PVT-2201-203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗