ClinicalTrials.gg
RecruitingNCT06978725BEACONUpdated Nov 3, 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 44 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

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

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Updated Nov 3, 2026First sites in Australia and United Kingdom40 sites addedGo to Updates ↓
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

Browse trials for

Keywords

  • sarcoidosis
  • cutaneous sarcoidosis
  • brepocitinib
03

In context

Sarcoidosis

271 studies on the registry are indexed under Sarcoidosis; 51 are open to participants now.

This study's planned enrollment of 168 is above the median of 50 across 145 interventional studies indexed under Sarcoidosis.

Browse Sarcoidosis studies →

Lead sponsor

Priovant Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults subjects
  2. Cutaneous sarcoidosis with characteristic skin histology
  3. A CSAMI activity score ≥ 10
  4. Weight > 40 kg to \< 130 kg, and with a (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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

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

06

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

07

Study locations

44 of 44 sites recruiting
  • Clinical Trial Site
    Birmingham, Alabama 27516, United States
    Recruiting
  • Clinical Trial Site
    Phoenix, Arizona 85054, United States
    Recruiting
  • Clinical Trial Site
    Tucson, Arizona 85718, United States
    Recruiting
  • Clinical Trial Site
    San Francisco, California 94115, United States
    Recruiting
  • Clinical Trial Site
    New Haven, Connecticut 06519, United States
    Recruiting
  • Clinical Trial Site
    Washington D.C., District of Columbia 10060, United States
    Recruiting
  • Clinical Trial Site
    Atlanta, Georgia 30322, United States
    Recruiting
  • Clinical Trial Site
    Sandy Springs, Georgia 30328, United States
    Recruiting
  • Clinical Trial Site
    Chicago, Illinois 60612, United States
    Recruiting
  • Clinical Trial Site
    Chicago, Illinois 60637, United States
    Recruiting
  • Clinical Trial Site
    Kansas City, Kansas 66160, United States
    Recruiting
  • Clinical Trial Site
    Louisville, Kentucky 40241, United States
    Recruiting
  • Clinical Trial Site
    New Orleans, Louisiana 41076, United States
    Recruiting
  • Clinical Trial Site
    Baltimore, Maryland 21201, United States
    Recruiting
  • Clinical Trial Site
    Boston, Massachusetts 02115, United States
    Recruiting
  • Clinical Trial Site
    Ann Arbor, Michigan 48103, United States
    Recruiting
  • Clinical Trial Site
    Ann Arbor, Michigan 48109, United States
    Recruiting
  • Clinical Trial Site
    Troy, Michigan 48084, United States
    Recruiting
  • Clinical Trial Site
    St Louis, Missouri 63110, United States
    Recruiting
  • Clinical Trial Site
    Lebanon, New Hampshire 03766, United States
    Recruiting
  • Clinical Trial Site
    Brooklyn, New York 11203, United States
    Recruiting
  • Clinical Trial Site
    Lake Success, New York 11042, United States
    Recruiting
  • Clinical Trial Site
    New York, New York 10016, United States
    Recruiting
  • Clinical Trial Site
    New York, New York 10029, United States
    Recruiting
  • Clinical Trial Site
    Rochester, New York 14620, United States
    Recruiting
  • Clinical Trial Site
    Chapel Hill, North Carolina 27516, United States
    Recruiting
  • Clinical Trial Site
    Durham, North Carolina 27703, United States
    Recruiting
  • Clinical Trial Site
    Greenville, North Carolina 27834, United States
    Recruiting
  • Clinical Trial Site
    Cleveland, Ohio 44195, United States
    Recruiting
  • Clinical Trial Site
    Fairborn, Ohio 45324, United States
    Recruiting
  • Clinical Trial Site
    Hershey, Pennsylvania 17033, United States
    Recruiting
  • Clinical Trial Site
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Clinical Trial Site
    Philadelphia, Pennsylvania 19140, United States
    Recruiting
  • Clinical Trial Site
    Charleston, South Carolina 29425, United States
    Recruiting
  • Clinical Trial Site
    Houston, Texas 77030, United States
    Recruiting
  • Clinical Trial Site
    Norfolk, Virginia 23502, United States
    Recruiting
  • Clinical Trial Site
    Richmond, Virginia 23219, United States
    Recruiting
  • Clinical Trial Site
    Madison, Wisconsin 53715, United States
    Recruiting
  • Clinical Trial Site
    Milwaukee, Wisconsin 53226, United States
    Recruiting
  • Clinical Trial Site
    Melbourne, Victoria 3004, Australia
    Recruiting
  • Clinical Trial Site
    Parkville, Victoria 3050, Australia
    Recruiting
  • Clinical Trial Site
    Coventry, CV22DX, United Kingdom
    Recruiting
  • Clinical Trial Site
    London, SE 59RS, United Kingdom
    Recruiting
  • Clinical Trial Site
    Manchester, M13 9WL, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2025 (actual). Primary completion is estimated for Dec 2028, 44 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2025
First posted
May 18, 2025
StartActual
Apr 9, 2025
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2029
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
40 sites added — first sites in Australia and United Kingdom
Show 40 added (35 United States, 3 United Kingdom, 2 Australia)
  • Clinical Trial Site · Birmingham, United States
  • Clinical Trial Site · Phoenix, United States
  • Clinical Trial Site · Tucson, United States
  • Clinical Trial Site · New Haven, United States
  • Clinical Trial Site · Washington D.C., United States
  • Clinical Trial Site · Atlanta, United States
  • Clinical Trial Site · Sandy Springs, United States
  • Clinical Trial Site · Chicago, United States
  • Clinical Trial Site · Chicago, United States
  • Clinical Trial Site · Kansas City, United States
  • Clinical Trial Site · Louisville, United States
  • Clinical Trial Site · New Orleans, United States
  • Clinical Trial Site · Baltimore, United States
  • Clinical Trial Site · Boston, United States
  • Clinical Trial Site · Ann Arbor, United States
  • Clinical Trial Site · Ann Arbor, United States
  • Clinical Trial Site · Troy, United States
  • Clinical Trial Site · St Louis, United States
  • Clinical Trial Site · Lebanon, United States
  • Clinical Trial Site · Brooklyn, United States
  • Clinical Trial Site · Lake Success, United States
  • Clinical Trial Site · New York, United States
  • Clinical Trial Site · New York, United States
  • Clinical Trial Site · Rochester, United States
  • Clinical Trial Site · Chapel Hill, United States
  • Clinical Trial Site · Greenville, United States
  • Clinical Trial Site · Cleveland, United States
  • Clinical Trial Site · Fairborn, United States
  • Clinical Trial Site · Hershey, United States
  • Clinical Trial Site · Philadelphia, United States
  • …and 10 more on the registry record
across 2 updates, Oct 21, 2026 – Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    5 sites added — first sites in Australia and United Kingdom
    Show 5 added (3 United Kingdom, 2 Australia)
    • Clinical Trial Site · Melbourne, Australia
    • Clinical Trial Site · Parkville, Australia
    • Clinical Trial Site · Coventry, United Kingdom
    • Clinical Trial Site · London, United Kingdom
    • Clinical Trial Site · Manchester, United Kingdom
    + 1 other change: verification date
  2. Oct 21, 2026
    35 sites added
    Show 35 added (35 United States)
    • Clinical Trial Site · Birmingham, United States
    • Clinical Trial Site · Phoenix, United States
    • Clinical Trial Site · Tucson, United States
    • Clinical Trial Site · New Haven, United States
    • Clinical Trial Site · Washington D.C., United States
    • Clinical Trial Site · Atlanta, United States
    • Clinical Trial Site · Sandy Springs, United States
    • Clinical Trial Site · Chicago, United States
    • Clinical Trial Site · Chicago, United States
    • Clinical Trial Site · Kansas City, United States
    • Clinical Trial Site · Louisville, United States
    • Clinical Trial Site · New Orleans, United States
    • Clinical Trial Site · Baltimore, United States
    • Clinical Trial Site · Boston, United States
    • Clinical Trial Site · Ann Arbor, United States
    • Clinical Trial Site · Ann Arbor, United States
    • Clinical Trial Site · Troy, United States
    • Clinical Trial Site · St Louis, United States
    • Clinical Trial Site · Lebanon, United States
    • Clinical Trial Site · Brooklyn, United States
    • Clinical Trial Site · Lake Success, United States
    • Clinical Trial Site · New York, United States
    • Clinical Trial Site · New York, United States
    • Clinical Trial Site · Rochester, United States
    • Clinical Trial Site · Chapel Hill, United States
    • Clinical Trial Site · Greenville, United States
    • Clinical Trial Site · Cleveland, United States
    • Clinical Trial Site · Fairborn, United States
    • Clinical Trial Site · Hershey, United States
    • Clinical Trial Site · Philadelphia, United States
    • …and 5 more on the registry record

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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
Nov 3, 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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Studies of the drug tested here: PF-06700841

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