Cutaneous SarcoidosisPhase 2/3BEACONNCT06978725
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
A Phase 2/3 study testing Oral Brepocitinib in people with Cutaneous Sarcoidosis, run by Priovant Therapeutics, Inc. at 39 sites in United States.
Trial summary
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Sarcoidosis
- What is being tested?
- Oral Brepocitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 39 sitesUnited States
- Study dates
- 9 Apr 2025to 31 Dec 2029
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country. Contact the study team or a site near you to ask about taking part.
39 sites in 1 country
United States39 sites, 39 recruiting
- Recruiting
Clinical Trial Site
Ann Arbor, Michigan, 48103
- Recruiting
Clinical Trial Site
Ann Arbor, Michigan, 48109
- Recruiting
Clinical Trial Site
Atlanta, Georgia, 30322
- Recruiting
Clinical Trial Site
Baltimore, Maryland, 21201
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Clinical Trial Site
Birmingham, Alabama, 27516
- Recruiting
Clinical Trial Site
Boston, Massachusetts, 02115
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Clinical Trial Site
Brooklyn, New York, 11203
- Recruiting
Clinical Trial Site
Chapel Hill, North Carolina, 27516
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Clinical Trial Site
Charleston, South Carolina, 29425
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Clinical Trial Site
Chicago, Illinois, 60612
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Clinical Trial Site
Chicago, Illinois, 60637
- Recruiting
Clinical Trial Site
Cleveland, Ohio, 44195
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Clinical Trial Site
Durham, North Carolina, 27703
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Clinical Trial Site
Fairborn, Ohio, 45324
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Clinical Trial Site
Greenville, North Carolina, 27834
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Clinical Trial Site
Hershey, Pennsylvania, 17033
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Clinical Trial Site
Houston, Texas, 77030
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Clinical Trial Site
Kansas City, Kansas, 66160
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Clinical Trial Site
Lake Success, New York, 11042
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Clinical Trial Site
Lebanon, New Hampshire, 03766
- Recruiting
Clinical Trial Site
Louisville, Kentucky, 40241
- Recruiting
Clinical Trial Site
Madison, Wisconsin, 53715
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Clinical Trial Site
Milwaukee, Wisconsin, 53226
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Clinical Trial Site
New Haven, Connecticut, 06519
- Recruiting
Clinical Trial Site
New Orleans, Louisiana, 41076
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Clinical Trial Site
New York, New York, 10016
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Clinical Trial Site
New York, New York, 10029
- Recruiting
Clinical Trial Site
Norfolk, Virginia, 23502
- Recruiting
Clinical Trial Site
Philadelphia, Pennsylvania, 19104
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Clinical Trial Site
Philadelphia, Pennsylvania, 19140
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Clinical Trial Site
Phoenix, Arizona, 85054
- Recruiting
Clinical Trial Site
Richmond, Virginia, 23219
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Clinical Trial Site
Rochester, New York, 14620
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Clinical Trial Site
San Francisco, California, 94115
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Clinical Trial Site
Sandy Springs, Georgia, 30328
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Clinical Trial Site
St Louis, Missouri, 63110
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Clinical Trial Site
Troy, Michigan, 48084
- Recruiting
Clinical Trial Site
Tucson, Arizona, 85718
- Recruiting
Clinical Trial Site
Washington D.C., District of Columbia, 10060
About this study
Official 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
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.
- Conditions
- Cutaneous Sarcoidosis
- Being tested
- Oral Brepocitinib, Oral Placebo
- Keywords
- sarcoidosis, cutaneous sarcoidosis, brepocitinib
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral BrepocitinibDrug
Oral Brepocitinib
Oral PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Brepocitinib Dose Level 1 | Experimental | Oral Brepocitinib Receives: Drug: Oral Brepocitinib |
| Part 1: Brepocitinib Dose Level 2 | Experimental | Oral Brepocitinib Receives: Drug: Oral Brepocitinib |
| Part 1: Placebo | Placebo comparator | Not described Receives: Drug: Oral Placebo |
| Part 2: Brepocitinib Dose Level 1 | Experimental | Oral Brepocitinib Receives: Drug: Oral Brepocitinib |
| Part 2: Placebo | Placebo comparator | Not described Receives: Drug: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Measured: Week 16
Part 2: Proportion of participants achieving a reduction in Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) from baseline to Week 16.
Measured: 16 Weeks
Secondary outcomes (2)
Part 1: Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score
Measured: 16 Weeks
Part 2: Proportion of participants achieving a low Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start9 Apr 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Priovant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978725
- Sponsor's protocol ID
- PVT-2201-203
- Acronym
- BEACON
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No