Trials / Completed
CompletedNCT03594227
ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ATI-501 Oral Suspension Compared to Placebo in Adult Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Aclaris Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This Phase 2, multicenter, randomized study will evaluate the safety, tolerability and efficacy of ATI-501 for the treatment of Alopecia Areata (AA), Alopecia Universalis (AU) or Alopecia Totalis (AT) in adult subjects.
Detailed description
This Phase 2, multicenter, randomized study will evaluate the safety, tolerability and efficacy of ATI-501 for the treatment of Alopecia Areata (AA), Alopecia Universalis (AU) or Alopecia Totalis (AT) in adult subjects. Subjects will be required to have a clinical diagnosis of stable AA, AU, or AT. A total of approximately 80 subjects will be randomized.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATI-501 400mg BID (Low dose) | ATI-501 400mg BID oral low dose for oral administration |
| DRUG | ATI-501 600mg BID (Mid dose) | ATI-501 600mg BID oral mid dose for oral administration |
| DRUG | ATI-501 800mg BID (High dose) | ATI-501 800mg BID high dose for oral administration |
| DRUG | Placebo | Placebo - oral administration |
Timeline
- Start date
- 2018-06-11
- Primary completion
- 2019-06-06
- Completion
- 2019-06-18
- First posted
- 2018-07-20
- Last updated
- 2020-09-16
- Results posted
- 2020-09-16
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03594227. Inclusion in this directory is not an endorsement.