Evaluating Brepocitinib for Treating Skin Sarcoidosis
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Cutaneous Sarcoidosis
This study tests if an oral medication called brepocitinib can help adults with skin sarcoidosis feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Priovant Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | brepocitinib |
| Locations | 4 sites (San Francisco, California and 3 other locations) |
| Trial ID | NCT06978725 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of oral brepocitinib in adults diagnosed with cutaneous sarcoidosis. Participants will receive either the active medication or a placebo to determine the drug's impact on their condition. The study focuses on individuals with a specific activity score and confirmed skin biopsy results. It aims to provide insights into a potential new treatment option for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 74 with a confirmed diagnosis of cutaneous sarcoidosis and a specific activity score.
Not a fit: Patients with a history of certain malignancies, high risk of thrombosis, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this could offer a new effective treatment option for patients suffering from cutaneous sarcoidosis.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in treating other forms of sarcoidosis with targeted therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults subjects (18-74) 2. Cutaneous sarcoidosis with characteristic skin biopsy histology 3. A CSAMI activity score ≥ 10 4. Weight \> 40 kg to \< 130 kg with BMI \< 40 kg/m2 . Exclusion Criteria 1. History of * Lymphoproliferative disorder * Active malignancy; * History of cancer within 5 years prior to baseline (exceptions for 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
Where this trial is running
San Francisco, California and 3 other locations
- Clinical Trial Site — San Francisco, California, United States (Recruiting)
- Clinical Trial Site — Durham, North Carolina, United States (Recruiting)
- Clinical Trial Site — Philadelphia, Pennsylvania, United States (Recruiting)
- Clinical Trial Site — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Administrator
- Email: clinicaltrials@priovant.com
- Phone: (212) 634-9743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.