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NCT Number: NCT06978725

A Phase 2/3 Study of Brepocitinib in Adults With Cutaneous Sarcoidosis

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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

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
  • Cutaneous sarcoidosis with characteristic skin biopsy histology
  • A CSAMI activity score ≥ 10
  • Weight > 40 kg to < 130 kg, and with a body mass index (BMI) ≤ 45 kg/m2.

Exclusion criteria

  • History of cancer, with the exception of the following cancers with documentation of complete resection and no evidence of recurrence for ≥ 1 year: 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

Oral Brepocitinib

oral placebo

Drug

Placebo

Primary outcomes

  1. Part 1: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

    Time frame: Week 16

  2. Part 2: Proportion of participants achieving at least a 50% reduction in Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) from baseline to Week 16.

    Time frame: 16 Weeks

Secondary outcomes

  1. Part 1: Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score

    Time frame: 16 Weeks

  2. Part 2: Proportion of participants achieving a low Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score

    Time frame: 16 weeks

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 2/3 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
2028
Study completion
2029
First posted
May 18, 2025
Registry last updated
Aug 21, 2026

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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