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RecruitingNCT06978725BEACONUpdated Aug 27, 2026

A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis

A Phase 2/3 interventional study of Oral Brepocitinib and Oral Placebo in Cutaneous Sarcoidosis, sponsored by Priovant Therapeutics, Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Priovant Therapeutics, Inc. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Cutaneous Sarcoidosis

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Keywords

  • sarcoidosis
  • cutaneous sarcoidosis
  • brepocitinib
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  1. 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.
  2. High risk of thrombosis or cardiovascular disease
  3. High risk of herpes zoster
  4. Active or recent infection
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
168 participants (estimated)

Study arms

  • Experimental
    Part 1: Brepocitinib Dose Level 1

    Oral Brepocitinib

    Drug: Oral Brepocitinib

  • Experimental
    Part 1: Brepocitinib Dose Level 2

    Oral Brepocitinib

    Drug: Oral Brepocitinib

  • Placebo comparator
    Part 1: Placebo

    Drug: Oral Placebo

  • Experimental
    Part 2: Brepocitinib Dose Level 1

    Oral Brepocitinib

    Drug: Oral Brepocitinib

  • Placebo comparator
    Part 2: Placebo

    Drug: Oral Placebo

Interventions

  • DrugOral Brepocitinib

    Oral Brepocitinib

  • DrugOral Placebo

    Placebo

05

What researchers measure

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 a 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

06

Study locations

4 of 4 sites recruiting
  • Clinical Trial Site
    San Francisco, California 94115, United States
    Recruiting
  • Clinical Trial Site
    Durham, North Carolina 27703, United States
    Recruiting
  • Clinical Trial Site
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Clinical Trial Site
    Madison, Wisconsin 53715, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06978725
Lead sponsor
Priovant Therapeutics, Inc.
Responsible party
Sponsor
First posted
May 18, 2025
Start date
Apr 9, 2025
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Aug 27, 2026

Study contacts

Clinical Trial Administrator
Contact
clinicaltrials@priovant.com
(212) 634-9743

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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