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
- Are there results?
- Not yet: the study is under way
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
- Recruiting
Clinical Trial Site
Birmingham, Alabama, 27516
- Recruiting
Clinical Trial Site
Boston, Massachusetts, 02115
- Recruiting
Clinical Trial Site
Brooklyn, New York, 11203
- Recruiting
Clinical Trial Site
Chapel Hill, North Carolina, 27516
- Recruiting
Clinical Trial Site
Charleston, South Carolina, 29425
- Recruiting
Clinical Trial Site
Chicago, Illinois, 60612
- Recruiting
Clinical Trial Site
Chicago, Illinois, 60637
- Recruiting
Clinical Trial Site
Cleveland, Ohio, 44195
- Recruiting
Clinical Trial Site
Durham, North Carolina, 27703
- Recruiting
Clinical Trial Site
Fairborn, Ohio, 45324
- Recruiting
Clinical Trial Site
Greenville, North Carolina, 27834
- Recruiting
Clinical Trial Site
Hershey, Pennsylvania, 17033
- Recruiting
Clinical Trial Site
Houston, Texas, 77030
- Recruiting
Clinical Trial Site
Kansas City, Kansas, 66160
- Recruiting
Clinical Trial Site
Lake Success, New York, 11042
- Recruiting
Clinical Trial Site
Lebanon, New Hampshire, 03766
- Recruiting
Clinical Trial Site
Louisville, Kentucky, 40241
- Recruiting
Clinical Trial Site
Madison, Wisconsin, 53715
- Recruiting
Clinical Trial Site
Milwaukee, Wisconsin, 53226
- Recruiting
Clinical Trial Site
New Haven, Connecticut, 06519
- Recruiting
Clinical Trial Site
New Orleans, Louisiana, 41076
- Recruiting
Clinical Trial Site
New York, New York, 10016
- Recruiting
Clinical Trial Site
New York, New York, 10029
- Recruiting
Clinical Trial Site
Norfolk, Virginia, 23502
- Recruiting
Clinical Trial Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Clinical Trial Site
Philadelphia, Pennsylvania, 19140
- Recruiting
Clinical Trial Site
Phoenix, Arizona, 85054
- Recruiting
Clinical Trial Site
Richmond, Virginia, 23219
- Recruiting
Clinical Trial Site
Rochester, New York, 14620
- Recruiting
Clinical Trial Site
San Francisco, California, 94115
- Recruiting
Clinical Trial Site
Sandy Springs, Georgia, 30328
- Recruiting
Clinical Trial Site
St Louis, Missouri, 63110
- Recruiting
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06978725
- Acronym / sponsor ID
- BEACON / PVT-2201-203
- Conditions
- Cutaneous Sarcoidosis
- Keywords
- sarcoidosis, cutaneous sarcoidosis, brepocitinib
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Priovant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: Brepocitinib Dose Level 1 | Experimental | Drug: Oral BrepocitinibOral Brepocitinib |
| Part 1: Brepocitinib Dose Level 2 | Experimental | Drug: Oral BrepocitinibOral Brepocitinib |
| Part 1: Placebo | Placebo comparator | Drug: Oral Placebo |
| Part 2: Brepocitinib Dose Level 1 | Experimental | Drug: Oral BrepocitinibOral Brepocitinib |
| Part 2: Placebo | Placebo comparator | Drug: Oral Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral BrepocitinibOral Brepocitinib | Drug | Part 1: Brepocitinib Dose Level 1, Part 1: Brepocitinib Dose Level 2, Part 2: Brepocitinib Dose Level 1 |
| Oral PlaceboPlacebo | Drug | Part 1: Placebo, Part 2: Placebo |
Primary outcome
Part 1: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Time frame: 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.
Time frame: 16 Weeks
2 secondary outcomes
Part 1: Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score
Time frame: 16 Weeks
Part 2: Proportion of participants achieving a low Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Cutaneous Sarcoidosis
Not yet recruitingPhase 2
Sirolimus in Cutaneous Sarcoidosis
Sarcoidosis, Cutaneous Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral Brepocitinib in people with Cutaneous Sarcoidosis, run by Priovant Therapeutics, Inc. at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Administrator ((212) 634-9743, clinicaltrials@priovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0 (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.