A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo
Trial Parameters
Brief Summary
This is a multi-center, parallel-group, open-label, randomized, Phase 1b study to explore the safety, clinical activity, pharmacokinetics and pharmacodynamics of DR-01 in adults with Alopecia Areata or Vitiligo.
Eligibility Criteria
General Inclusion Criteria 1. Subjects aged ≥ 18 with the ability to understand and comply with protocol-required study procedures, and voluntarily sign a written informed consent document. 2. Women of childbearing potential (postmenarcheal, has an intact uterus and at least 1 ovary, and is \< 1 year postmenopausal) must agree to use a highly effective method of contraception (as specified in Section 13.1.1 or as permitted by regional regulatory authorities) from enrollment through at least 20 weeks after last dose of DR-01. 3. Male subjects must agree to use acceptable effective method(s) of contraception (as specified in Section 13.1.1 or as permitted by regional regulatory authorities) from enrollment through at least 20 weeks after last dose of DR-01. Alopecia Areata-Specific Inclusion Criteria 4. Diagnosed with moderate to severe AA with \> 20% scalp hair loss at screening, according to SALT (Olsen 1999). 5. Current episode of AA lasting from \> 6 months to \< 10 years prior to sc