Taking peoplePhase 2/3
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Key facts
- Who runs it
- Priovant Therapeutics, Inc.
- Where
- Bologna and Siena, ItalySee the 2 sitesAlso in 7 other countries, 54 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 168 people, planned
- Started
- 9 Apr 2025
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Oral Brepocitinib
- Oral Placebo
- Record updated
- 3 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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 take part
- 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
- Active or recent infection
- High risk of herpes zoster
Where in Italy
Also in 7 other countries, 54 sites
- Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola MalpighiBologna, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria SeneseSiena, ItalyNot yet recruiting
About the trial
What the trial wants to find out
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.
The 5 groups in the trial
- Part 1: Brepocitinib Dose Level 1Treatment being tested
Oral Brepocitinib
Treatment: Oral Brepocitinib
- Part 1: Brepocitinib Dose Level 2Treatment being tested
Oral Brepocitinib
Treatment: Oral Brepocitinib
- Part 1: PlaceboPlacebo, for comparison
Treatment: Oral Placebo
- Part 2: Brepocitinib Dose Level 1Treatment being tested
Oral Brepocitinib
Treatment: Oral Brepocitinib
- Part 2: PlaceboPlacebo, for comparison
Treatment: Oral Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Publications
- Record updated
- 3 November 2026