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

Exclusion Criteria

• •Subjects meeting any of the following criteria are ineligible to participate in this study:
• •1. 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.
• •2. Use of live vaccines during the study and within 28 days prior to screening.
• •3. Known history of chronic alcohol abuse, IV drug abuse or illicit drug abuse within 1 year before screening.
• •4. 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.
• •5. 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.
• •6. Any of the following types of infection within 28 days of screening or before randomization:
• •1. Serious (requiring hospitalization, and/or IV anti-infective treatment).
• •2. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).
• •3. Viral reactivation of CMV, EBV, VZV or HSV infection requiring systemic therapy in the last 2 years. Periodic HSV viral reactivation (e.g., cold sore) treated with a short course of systemic antiviral therapy within the last 2 years would not be exclusionary.
• •7. Any of the following:
• •1. HIV infection.
• •2. Current infection with HBV (i.e., positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA).
• •3. Current infection with HCV (i.e., positive for HCV RNA).
• •8. Concurrent diagnosis or history of any autoimmune diseases other than AA or VT requiring systemic or topical immunotherapy.
• •9. Use of topical and oral JAK inhibitors within 4 and 8 weeks of randomization, respectively.
• •10. Use of lymphocyte depleting agents (e.g., rituximab, ocrelizumab, ofatumumab, ublituximab, thymoglobulin, alemtuzumab, etc.) within 6 months of screening or until lymphocyte counts have normalized.
• •11. Use of other biologics within 4 weeks of screening.
• •12. Use of oral immune suppressants (e.g., cyclosporine A, azathioprine, methotrexate, sulfasalazine, systemic corticosteroids, mycophenolate-mofetil,) within 28 days of screening. Topical steroid use is prohibited within 2 weeks of screening in VT and on scalp, eyebrows and eyelids in AA.
• •13. Intralesional steroid injection within 8 weeks of screening or within 5 half-lives, whichever is longer.
• •14. Herbal medications, including traditional Chinese medicine formulations, with unknown properties or known beneficial effects for VT or alopecia.
• •15. Untreated latent tuberculosis infection as indicated by IFNγ release assay, (appropriate therapy as defined by the World Health Organization and/or the United States Centers for Disease Control and Prevention). Without documentation of appropriate treatment.
• •16. Women who are currently pregnant or breastfeeding, or who intend to become pregnant or to breastfeed at any time during the study or within 20 weeks after receiving the last dose of DR-01.
• •17. Any other reason that may make the patient unsuitable for study participation, in the opinion of the Investigator or Medical Monitor
• •18. Subjects with intolerance or allergy to the investigational product or any of its components.
• •19. Estimated glomerular filtration rate \< 30 mL/min/1.73m2 (using the Chronic Kidney Disease Epidemiology Collaboration formula (Levey 2009).
• •20. Total bilirubin \>1.5 × upper limit of normal (ULN; \> 3 × ULN if known Gilbert's disease).
• •21. Aspartate aminotransferase and alanine aminotransferase \> 2.5 × ULN.
• •22. Diffuse AA, other forms of alopecia and other active inflammatory diseases of the scalp.
• •23. Use of phototherapy, platelet-rich plasma injections or non-steroid topical immunosuppressives during the trial and within 12 weeks or 5 half-lives prior to screening.
• •24. Any history of disseminated/complicated herpes zoster.
• •25. Have a history of eczema herpeticum within 12 months prior to screening or a history of 2 or more episodes of eczema herpeticum in the past.
• •26. Subjects that have other types of VT (including but not limited to segmental VT). Note: Mixed VT is permitted.
• •27. Currently have active forms of other hypopigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation \[melanoma and mycosis fungoides\], post-inflammatory hypopigmentation, pityriasis alba \[minor manifestation of atopic dermatitis\], senile leukoderma \[age-related depigmentation\], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma, and congenital hypopigmentation disorders including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditaria, xeroderma pigmentosum, and nevus depigmentosus). Note: Coexistence of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted.
• •28. Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (including but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at screening that in the opinion of the Investigator would interfere with evaluation of VT or response to treatment.
• •29. Use of permanent depigmentation treatment for VT and/or other types of pigmentation disorders (e.g., monobenzone or phenol) at any time.
• •30. Use of ultraviolet B phototherapy, psoralen ultraviolet A therapy, or other phototherapy within 4 weeks of screening.
• •31. Any history of disseminated/complicated or relapsing herpes zoster.
• •32. Have a history of eczema herpeticum within 12 months prior to screening or a history of 2 or more episodes of eczema herpeticum in the past.