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Cancer Vaccine

DR-01 for Alopecia Areata and Vitiligo

Phase 1
Recruiting
Research Sponsored by Dren Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with moderate to severe Alopecia Areata (AA) with > 20% scalp hair loss at screening
Have active or stable non-segmental Vitiligo (VT) at screening and baseline
Must not have
Have had any surgical procedure within 12 weeks prior to screening or any planned surgical procedure scheduled to occur during the study
Concurrent diagnosis or history of autoimmune diseases other than AA or VT requiring systemic or topical immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial is looking at a new treatment called DR-01 for adults with Alopecia Areata or Vitiligo to see how safe and effective it is."

Who is the study for?
This trial is for adults with Alopecia Areata or Vitiligo. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.
What is being tested?
The study tests DR-01's safety, effectiveness, and how the body processes it in patients with Alopecia Areata or Vitiligo. It's an early-phase trial (Phase 1b), meaning it's one of the first times this drug is being tested in humans.
What are the potential side effects?
Since this is a Phase 1b study primarily focused on safety, specific side effects of DR-01 are not listed but will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have lost more than 20% of my scalp hair due to Alopecia Areata.
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I have active or stable non-segmental vitiligo.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had surgery in the last 12 weeks and do not plan to during the study.
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I do not have an autoimmune disease needing systemic treatment besides AA or VT.
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I have not participated in a drug or device trial within the last 28 days.
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I have not had cancer or been treated for cancer in the last 5 years.
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I do not have HIV, hepatitis B, or hepatitis C.
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I am not pregnant, breastfeeding, nor planning to become pregnant.
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My kidney function, bilirubin, and liver enzymes are within normal ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: DL2 of DR-01Experimental Treatment1 Intervention
Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 2
Group II: DL1 of DR-01Experimental Treatment1 Intervention
Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 1
Group III: DL-3 of DR-01Experimental Treatment1 Intervention
Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 3

Find a Location

Who is running the clinical trial?

Dren BioLead Sponsor
4 Previous Clinical Trials
163 Total Patients Enrolled
Michael Rothenberg, MD, PhDStudy DirectorDren Bio
1 Previous Clinical Trials
36 Total Patients Enrolled
~40 spots leftby Sep 2026
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