A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo

NCT06602232 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DR-01-AIM-001
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 20

Brief 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.

Conditions

Alopecia Areata; Vitiligo

Keywords

AA; VT; Alopecia Areata; Alopecia; Vitiligo; Hair Diseases; Skin Diseases

Outcome Measures

Primary Outcomes (3)

• 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 score

  At week 24

• Mean change from baseline in VASI measures

  At week 24

Study Arms (4)

DL1 of DR-01

EXPERIMENTAL

Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 1

Drug: DR-01

DL2 of DR-01

EXPERIMENTAL

Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 2

Drug: DR-01

DL3 of DR-01

EXPERIMENTAL

Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 3

Drug: DR-01

DL4 of DR-01

EXPERIMENTAL

Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 4

Drug: DR-01

Interventions

DR-01 DRUG

DR-01 will be administered via IV infusion.

DL1 of DR-01; DL2 of DR-01; DL3 of DR-01; DL4 of DR-01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Agree to not use adhesive wigs (other than banded perimeter wigs) during the study
• Be willing to maintain the same hair style and hair dyeing throughout the study period.
• Subjects who shave their scalp must be willing to refrain from shaving their scalp for at least 2 weeks prior to each SALT assessment. Hair trimming outside the treatment areas to maintain the current hair style is permitted.
• Have active or stable non-segmental VT at screening and baseline defined as follows:
• Have a clinical diagnosis of non-segmental VT for at least 3 months; and
• Body surface area (BSA) involvement 4% to 60% excluding involvements at palms of the hands, dorsal aspect of fingers and thumbs including metacarpophalangeal joints, soles of the feet, or dorsal aspect of the feet; and
• BSA ≥ 0.25% involvement on the face excluding involvement at vermilion (confirmed by photographs at screening); and

You may not qualify if:

• Subjects meeting any of the following criteria are ineligible to participate in this study:
• 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).
• Any of the following:
• HIV infection.
• Current infection with HBV (i.e., positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA).
• Current infection with HCV (i.e., positive for HCV RNA).
• Concurrent diagnosis or history of any autoimmune diseases other than AA or VT requiring systemic or topical immunotherapy.
• Use of topical and oral JAK inhibitors within 4 and 8 weeks of randomization, respectively.

Sponsors & Collaborators

• Dren Bio: lead

Study Sites (20)

Dren Investigational Site

Northridge, California, 91344, United States

RECRUITING

Dren Investigational Site

Miami, Florida, 33155, United States

RECRUITING

Dren Investigational Site

Evans, Georgia, 30809, United States

RECRUITING

Dren Investigational Site

Meridian, Idaho, 83642, United States

RECRUITING

Dren Investigational Site

Indianapolis, Indiana, 46250, United States

RECRUITING

Dren Investigational Site

West Lafayette, Indiana, 47906, United States

RECRUITING

Dren Investigational Site

Worcester, Massachusetts, 01605, United States

NOT YET RECRUITING

Dren Investigational Site

Troy, Michigan, 48084, United States

RECRUITING

Dren Investigational Site

Philadelphia, Pennsylvania, 19103, United States

NOT YET RECRUITING

Dren Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Dren Investigational Site

Chattanooga, Tennessee, 37421, United States

RECRUITING

Dren Investigational Site

San Antonio, Texas, 78215, United States

RECRUITING

Dren Investigational Site

Charlestown, New South Wales, 2290, Australia

RECRUITING

Dren Investigational Site

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Dren Investigational Site

Coorparoo, Queensland, 4151, Australia

RECRUITING

Dren Investigational Site

South Yarra, Victoria, 3141, Australia

RECRUITING

Dren Investigational Site

Fremantle, Washington, Australia

RECRUITING

Dren Investigational Site

Auckland, 0632, New Zealand

RECRUITING

Dren Investigational Site

Christchurch, 8013, New Zealand

RECRUITING

Dren Investigational Site

Grafton, 1010, New Zealand

RECRUITING

MeSH Terms

Conditions

Alopecia Areata; Vitiligo; Alopecia; Hair Diseases; Skin Diseases

Condition Hierarchy (Ancestors)

Hypotrichosis; Skin and Connective Tissue Diseases; Hypopigmentation; Pigmentation Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Rothenberg, MD, PhD

  Dren Bio

  STUDY DIRECTOR

Central Study Contacts

Dren Central Contact

CONTACT

415-737-5277; DR-01-AIM-001_inquiries@drenbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); AU (5); NZ (3)