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This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brepocitinib Dose Level 1 | Experimental |
| |
| Brepocitinib Dose Level 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Brepocitinib | Drug | Drug: Oral Brepocitinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0 | Screening up to 28 days after the last dose of study drug at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score through Week 16. | CSAMI-A score is a measure of cutaneous sarcoidosis disease activity. A higher score indicates worse disease. Scores range from 0-165. | 16 Weeks |
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Inclusion Criteria:
Exclusion Criteria
History of
High risk of thrombosis or cardiovascular disease
High risk of herpes zoster
Active or recent infection
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Administrator | Contact | (212) 634-9743 | clinicaltrials@priovant.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Recruiting | San Francisco | California | 94115 | United States | |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| Oral Placebo | Drug | Drug: Oral Placebo |
|
| Clinical Trial Site |
| Recruiting |
| Durham |
| North Carolina |
| 27703 |
| United States |
| Clinical Trial Site | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Trial Site | Recruiting | Madison | Wisconsin | 53715 | United States |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |