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NCT Number: NCT06978725

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

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

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Key information

Conditions

Cutaneous Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Sarcoidosis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trial Site, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Brepocitinib

Drug

Drug: Oral Brepocitinib

oral placebo

Drug

Drug: Oral Placebo

Primary outcomes

  1. 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 outcomes

  1. Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score through Week 16.

    Time frame: 16 Weeks

    CSAMI-A score is a measure of cutaneous sarcoidosis disease activity. A higher score indicates worse disease. Scores range from 0-165.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Administrator

CONTACT

[email protected]

(212) 634-9743

Sponsors and collaborators

Lead sponsor

Priovant Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: BEACON

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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