DR-01 for Alopecia Areata and Vitiligo
This study is testing a drug called DR-01 in adults with Alopecia Areata (a condition causing hair loss) or Vitiligo (a condition causing skin discoloration). The main goals are to see how safe DR-01 is, how well people tolerate it, and if it shows any positive effects on hair regrowth or skin repigmentation. Researchers will also look at how the body processes DR-01. You may be able to join if you are at least 18 years old. The study plans to enroll 81 participants, but its current status is unclear.
- Study design
- This is an open-label, randomized study, meaning you and your doctors will know if you are receiving DR-01. It is a Phase 1b study and plans to include 81 participants.
- What's involved
- DR-01 will be given through an IV infusion. The study will measure safety and tolerability for up to 12 months, and changes in your condition at week 24.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and tolerability will be monitored for up to 12 months after starting the study. Changes in your condition will be measured at week 24.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06602232
A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentDren Bio
~81 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:DR-01
At a glance
Recruiting sites
0 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events as assessed by CTCAE v5.0.(Safety and Tolerability)
Measured over Up to 12 months
+2 more outcomes measured
Conditions
Where it's being run
20 sites across 15 statesNew Zealand3
Indiana2
Pennsylvania2
New South Wales2
California1
Florida1
Georgia1
Idaho1
Study leadership
- Michael Rothenberg, MD, PhD · STUDY_DIRECTOR · Dren Bio
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Incidence and severity of adverse events as assessed by CTCAE v5.0.(Safety and Tolerability)Up to 12 months
- Mean change from baseline in SALT scoreAt week 24
- Mean change from baseline in VASI measuresAt week 24