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+InterventionalTreatment
Dren 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
Alopecia Areata
Vitiligo
20 sites across 15 states
New Zealand3
Indiana2
Pennsylvania2
New South Wales2
California1
Florida1
Georgia1
Idaho1
  • Michael Rothenberg, MD, PhD · STUDY_DIRECTOR · Dren Bio

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • 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