Cutaneous Sarcoidosis
Conditions
Keywords
sarcoidosis, cutaneous sarcoidosis, brepocitinib
Brief summary
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.
Interventions
Oral Brepocitinib
DRUGOral Placebo
Placebo
Sponsors
Priovant Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults subjects 2. Cutaneous sarcoidosis with characteristic skin biopsy histology 3. A CSAMI activity score ≥ 10 4. Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) ≤ 45 kg/m2.
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0 | Week 16 |
| Part 2: Proportion of participants achieving a reduction in Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) from baseline to Week 16. | 16 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score | 16 Weeks |
| Part 2: Proportion of participants achieving a low Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score | 16 weeks |
Countries
United States
Contacts
CONTACTClinical Trial Administrator
Outcome results
None listed