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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-09

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Cutaneous Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Brepocitinib Dose Level 1

Group Type EXPERIMENTAL

Oral Brepocitinib

Intervention Type DRUG

Drug: Oral Brepocitinib

Brepocitinib Dose Level 2

Group Type EXPERIMENTAL

Oral Brepocitinib

Intervention Type DRUG

Drug: Oral Brepocitinib

Placebo

Group Type PLACEBO_COMPARATOR

Oral Placebo

Intervention Type DRUG

Drug: Oral Placebo

Interventions

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Oral Brepocitinib

Drug: Oral Brepocitinib

Intervention Type DRUG

Oral Placebo

Drug: Oral Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No