RECRUITINGPhase 2INTERVENTIONAL
A Phase 2 Study of the Safety and Efficacy of Brepocitinib in Adults With Cutaneous Sarcoidosis (BEACON)
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
About This Trial
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.
Who May Be Eligible (Plain English)
Who May Qualify:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Oral Brepocitinib
Drug: Oral Brepocitinib
DRUG
Oral Placebo
Drug: Oral Placebo
Locations (4)
Clinical Trial Site
San Francisco, California, United States
Clinical Trial Site
Durham, North Carolina, United States
Clinical Trial Site
Philadelphia, Pennsylvania, United States
Clinical Trial Site
Madison, Wisconsin, United States