A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo (NCT06602232) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo
United States, Australia, New Zealand81 participantsStarted 2024-10-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects aged ≥ 18 with the ability to understand and comply with protocol-required study procedures, and voluntarily sign a written informed consent document.
. 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.
. 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.
. Diagnosed with moderate to severe AA with \> 20% scalp hair loss at screening, according to SALT (Olsen 1999).
. Current episode of AA lasting from \> 6 months to \< 10 years prior to screening.
. No spontaneous improvement in the 6 months prior to screening or between screening and baseline (decrease in SALT score of ≤ 10, \> 10 would be an improvement).
. Patients with a current episode of AA lasting for ≥ 10 years may participate if there was regrowth in affected areas of the scalp over the 10 years prior to screening.
. Agree not to use any AA treatments during the study (Exception: Chronic treatment with bimatoprost ophthalmic solution for eyelashes and chronic treatment with 5 alpha reductase inhibitors, oral or topical minoxidil).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of adverse events as assessed by CTCAE v5.0.(Safety and Tolerability)
. Participation in an investigational drug or device trial in which administration of an investigational drug or device occurred within 28 days or 5 half-lives of screening, whichever is shorter.
. Use of live vaccines during the study and within 28 days prior to screening.
. Known history of chronic alcohol abuse, IV drug abuse or illicit drug abuse within 1 year before screening.
. Diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.
. Have had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening, or any planned surgical procedure scheduled to occur during the study.
. Any of the following types of infection within 28 days of screening or before randomization:
. Serious (requiring hospitalization, and/or IV anti-infective treatment).
. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).