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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Alopecia Areata-Specific Inclusion Criteria

• 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.

⁃ Vitiligo-Specific Inclusion Criteria

⁃ 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

‣ Subjects with active VT should have at least 1 active lesion defined as 1 of the following:

⁃ i. New/extending lesion(s) in the past 3 months (confirmed by photographs or medical record); ii. Confetti-like lesion(s); iii. Trichrome lesion(s); iv. Koebner phenomenon/ phenomena (excluding Type 1 \[history based isomorphic reaction\]); e. Coexistence of halo nevus/nevi (also known as Sutton nevus/ nevi) is permitted.

⁃ If receiving concomitant medications for any reason other than VT, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Subject must be willing to stay on a stable regimen during the duration of the study.

⁃ Must agree to follow the usual and habitual exposure to sun light and not change the use of sunblock and not to use tanning booths, sun lamps or other ultraviolet light sources other than provided/requested by the study team during the study.

Locations
United States
California
Dren Investigational Site
RECRUITING
Northridge
Florida
Dren Investigational Site
RECRUITING
Miami
Georgia
Dren Investigational Site
RECRUITING
Evans
Idaho
Dren Investigational Site
RECRUITING
Meridian
Indiana
Dren Investigational Site
RECRUITING
Indianapolis
Dren Investigational Site
RECRUITING
West Lafayette
Massachusetts
Dren Investigational Site
NOT_YET_RECRUITING
Worcester
Michigan
Dren Investigational Site
RECRUITING
Troy
Pennsylvania
Dren Investigational Site
NOT_YET_RECRUITING
Philadelphia
Dren Investigational Site
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Dren Investigational Site
RECRUITING
Chattanooga
Texas
Dren Investigational Site
RECRUITING
San Antonio
Other Locations
Australia
Dren Investigational Site
RECRUITING
Charlestown
Dren Investigational Site
RECRUITING
Coorparoo
Dren Investigational Site
RECRUITING
Darlinghurst
Dren Investigational Site
RECRUITING
Fremantle
Dren Investigational Site
RECRUITING
South Yarra
New Zealand
Dren Investigational Site
RECRUITING
Auckland
Dren Investigational Site
RECRUITING
Christchurch
Dren Investigational Site
RECRUITING
Grafton
Contact Information
Primary
Dren Central Contact
clinops@drenbio.com
415-737-5277
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2026-09
Participants
Target number of participants: 80
Treatments
Experimental: DL1 of DR-01
Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 1
Experimental: DL2 of DR-01
Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 2
Experimental: DL3 of DR-01
Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 3
Experimental: DL4 of DR-01
Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 4
Sponsors
Leads: Dren Bio

This content was sourced from clinicaltrials.gov

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