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