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ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis

NCT03594227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2020-09-16

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Aclaris Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Moran, RN · Aclaris Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2019-06-06
Completion
2019-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03594227 on ClinicalTrials.gov