Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03594227 · ClinicalTrials.gov registry record · Phase 2
ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
A Phase 2 study, sponsored by Aclaris Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
NCT03594227: Completed Phase 2 study, sponsored by Aclaris Therapeutics.
NCT03594227 is a Phase 2 study that has completed, run by Aclaris Therapeutics. The registered enrollment target is 87 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03594227, a Phase 2 study, has completed, sponsored by Aclaris Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
Study 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.
Primary Outcome
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. The primary efficacy variable was the percent change from baseline in SALT score at
Interventions
- DRUG Placebo
- DRUG ATI-501 400mg BID (Low dose)
- DRUG ATI-501 600mg BID (Mid dose)
- DRUG ATI-501 800mg BID (High dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2018-06-11 |
| Est. Completion | 2019-06-18 |
| Phase | Phase 2 |
What the finished NCT03594227 record still lists
NCT03594227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03594227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03594227 about?
NCT03594227 is a clinical study titled "ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis". 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.
What is the current status of trial NCT03594227?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2018-06-11. Estimated completion is 2019-06-18.
What interventions are being tested in trial NCT03594227?
The interventions under investigation include: Placebo (DRUG), ATI-501 400mg BID (Low dose) (DRUG), ATI-501 600mg BID (Mid dose) (DRUG), ATI-501 800mg BID (High dose) (DRUG).
Who is sponsoring clinical trial NCT03594227?
This trial is sponsored by Aclaris Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03594227's enrollment target sits among peer trials
87 810th of 2000 higher than 1,189 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03292601 · 87 participants · NA
Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
- NCT04291105 · 87 participants · Phase 2
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
- NCT04565795 · 87 participants · NA
Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
- NCT05607004 · 87 participants · Phase 2
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI