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This is a phase 2a, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel, 0.37% in adults with vitiligo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerdulatinib 0.37% gel | Experimental | Cerdulatinib 0.37% gel applied topically twice daily |
|
| Vehicle gel | Placebo Comparator | Vehicle gel applied topically twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerdulatinib 0.37% gel | Drug | Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs | Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate) | Baseline through Week 7 |
| Laboratory Values | Clinically significant abnormal lab values | Baseline through Week 7 |
| Adverse Events | Frequency, severity, and duration of adverse events | Baseline through Week 7 |
| Local Tolerability Scale Score | Assessment of local site investigational product administration | Baseline, Week 2, Week 4, Week 6, and Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of cerdulatinib | Plasma concentration | Days 1, 15, 29 and 43 |
| Blister fluid biomarker concentration | From active treated lesions and untreated nonlesional skin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael McLaughlin | Dermavant Sciences GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermavant Investigational Site | Irvine | California | 92617 | United States | ||
| Dermavant Investigational Site |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 25, 2022 | Nov 17, 2022 | 3 |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000595259 | 4-(cyclopropylamino)-2-((4-(4-(ethylsulfonyl)piperazin-1-yl)phenyl)amino)pyrimidine-5-carboxamide |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Vehicle gel | Drug | Vehicle gel applied topically twice daily for 6 weeks |
|
| Baseline and Week 6 |
| Worcester |
| Massachusetts |
| 01605 |
| United States |