Alopecia Areata Clinical Trial
Official title:
Open-Label Study of ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)
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.
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.
Subjects who complete 24 weeks of active treatment with ATI-501 Oral Suspension or Placebo
Suspension in study ATI-501-AUAT-201 will be assessed for eligibility to enter the study. At
Visit 9 in study ATI-501-AUAT-201, subjects who did not experience any adverse events (AEs),
serious adverse events (SAEs), or tolerability issues that met study discontinuation criteria
in study ATI-501-AUAT-201 and who in the opinion of the investigator are capable of
re-growing or maintaining scalp hair and meet the entry criteria are eligible to enroll in
this open-label study.
Enrolled subjects will apply ATI-502 Topical Solution, 0.46% BID to the entire scalp and if
applicable, the eyebrow(s) and return for safety and efficacy assessments as detailed in the
Schedule of Assessments (Table 3). Assessment of response to treatment will be performed at
Week 4, Week 8, Week 16, Week 24, and post-treatment Week 28. Safety and tolerability will be
evaluated at each study visit by assessment of adverse events, clinical laboratory tests, and
vital signs, and at Week 24, and physical examination findings
;
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