A Phase 2 Study of the Safety and Efficacy of Brepocitinib in Adults With Cutaneous Sarcoidosis (BEACON)

Priovant Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Cutaneous Sarcoidosis

Treatments: Drug: Oral Brepocitinib; Drug: Oral Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06978725

PVT-2201-203

Details and patient eligibility

About

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

28 participants in 3 patient groups, including a placebo group

Brepocitinib Dose Level 1

Experimental group

Treatment:

Drug: Oral Brepocitinib

Brepocitinib Dose Level 2

Experimental group

Treatment:

Drug: Oral Brepocitinib

Placebo

Placebo Comparator group

Treatment:

Drug: Oral Placebo