A Pilot, Safety and Clinical Activity, Phase 1b Study of DR-01 in Adults With Alopecia Areata or Vitiligo - National Alopecia Areata Foundation | NAAF

A Pilot, Safety and Clinical Activity, Phase 1b Study of DR-01 in Adults With Alopecia Areata or Vitiligo

Study type: Clinical Trials Posting date: 11/21/2025 Last updated: 11/21/2025 Status: Active Phase: 1b Country: USA, Australia, New Zealand Eligibility:
  • Adults 18 years of age or older
  • Diagnosed with moderate to severe AA with > 20% scalp hair loss
  • Current episode of AA lasting from at least 6 months to less than 10 years prior to screening.
  • No spontaneous improvement in the 6 months prior to screening or between screening and baseline
  • 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).

For additional eligibility criteria, see clinicaltrials.gov.
Drug: DR-01 Administration: IV Infusion Sponsor: Dren Bio ClinicalTrials.gov link: Click here Location: Multiple locations in USA, Australia, New Zealand


 Description:

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.

For more information contact Dren Bio by phone (415-737-5277) or email at clinops@drenbio.com or review the study listing at clinicaltrials.gov.