ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)
Condition: Alopecia Areata; Alopecia Universalis; Alopecia Totalis
MeSH terms: Alopecia; Alopecia Areata
Intervention: ATI 502 0.46% Topical Solution
Intervention description: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This Phase 2, multicenter, open-label study will evaluate the safety, tolerability, efficacy, and durability of efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia areata (AA), alopecia universalis (AU) and alopecia totalis (AT) in adult subjects who completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open label study of ATI-502 Topical Solution for the treatment of AA, AU, and AT
      with the following goals:

        -  To assess the safety, tolerability, and efficacy of ATI-502 Topical Solution in subjects
           with AA, AU or AT following 24 weeks of treatment with ATI-501 Oral Suspension or
           Placebo Suspension.

        -  To assess the ability of ATI-502 Topical Solution to maintain or improve hair regrowth
           in subjects previously treated with ATI-501 Oral Suspension or Placebo Suspension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must meet the following criteria to be eligible for participation in the
             study:

               1. Subject must be able to comprehend and willing to sign the Informed Consent Form
                  (ICF).

               2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed
                  consent.

               3. Subject has completed 24 weeks of treatment and the assessments for Visit 9 in
                  study ATI-501-AUAT-201.

               4. Subject has not experienced any AEs, SAEs or tolerability issues that met study
                  discontinuation criteria in ATI-501-AUAT-201.

               5. Subject is capable of regrowing scalp hair or maintaining prior scalp hair
                  regrowth from ATI-501-AUAT-201 in the opinion of the investigator.

               6. If a woman of childbearing potential (WOCBP), must have a negative urine
                  pregnancy test at Visit 1 and agree to: use a highly effective method of birth
                  control for the duration of the study; not be planning a pregnancy during the
                  study duration and use contraception for 30 days after last application of study
                  medication. (Refer to Section 8.4).

               7. Be in good general health and free of any known disease state or physical
                  condition which, in the investigator's opinion, might impair evaluation of the
                  subject or which might expose the subject to an unacceptable risk by study
                  participation.

               8. Be willing to maintain the same general hair style throughout the study period.
                  Subjects who shave their scalp must be willing to refrain from shaving their
                  scalp for at least one week or longer prior to each study visit, as determined by
                  the investigator based on visible scalp hair growth. Hair trimming outside the
                  treatment areas to maintain the current hair style is permitted.

               9. Be willing and able to follow all study instructions and to attend all study
                  visits.

              10. Sexually active male subjects must agree to use a barrier method of contraception
                  from the first application of study medication to at least 30 days after the last
                  application of study medication.

        Exclusion Criteria:

          -  Subjects are excluded from this study if any 1 or more of the following criteria is
             met:

               1. Any study medication discontinuation criteria are met during participation in
                  study ATI-501-AUAT-201.

               2. Females who are nursing, pregnant, or planning to become pregnant for the
                  duration of the study and up to 30 days after the last application of study
                  medication.

               3. The presence of a permanent or difficult to remove hairpiece or wig that will, in
                  the opinion of the investigator, interfere with study assessments if not removed
                  at each visit.

               4. Sensitivity to any of the ingredients in the study medications.

               5. Unwillingness to refrain from weaves, hair extensions, or shaving of the scalp
                  for at least one week or longer prior to each study visit, as determined by the
                  investigator based on visible scalp hair growth the duration of the study.