A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata

NCT03354637 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ATI-50002-AA-201
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 23

Brief Summary

Primary:

• To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA) Secondary:
• To evaluate key clinical outcome assessments

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24

  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 at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. 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. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.

  Baseline - Week 24

Secondary Outcomes (16)

• Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24

  Baseline - Week 24

• Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24

  Baseline - Week 24

• Mean Change From Baseline in Alopecia Density and Extent Score at Week 24

  Baseline - Week 24

• Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24

  Baseline - Week 24

• Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24

  Baseline - Week 24

Study Arms (3)

ATI-50002 high dose Topical Solution

ACTIVE COMPARATOR

High dose active

Drug: ATI-50002 high dose

ATI-50002 low dose Topical Solution

ACTIVE COMPARATOR

low dose active

Drug: ATI-50002 low dose

Vehicle Topical Solution

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

ATI-50002 high dose DRUG

Topical solution

ATI-50002 high dose Topical Solution

ATI-50002 low dose DRUG

Topical solution

ATI-50002 low dose Topical Solution

Placebo DRUG

Topical solution

Vehicle Topical Solution

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a clinical diagnosis of stable patchy alopecia areata (AA) defined as no current areas of spontaneous regrowth.
• Have a Severity of Alopecia Tool (SALT) score of at least 15% up to 95% total scalp hair loss determined by the study investigator at baseline.
• Have a duration of the current episode of scalp hair loss of a minimum of 6 months and a maximum of 12 years.
• If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) 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.

You may not qualify if:

• 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.
• Diffuse alopecia areata.
• Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia, etc.).
• Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety.
• Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AA or interfere with the study conduct or evaluations.
• 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.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (23)

Aclaris Investigator Site

Encinitas, California, 92024, United States

Location

Aclaris Investigator Site

Laguna Hills, California, 92653, United States

Location

Aclaris Investigator Site

Redwood City, California, 94063, United States

Location

Aclaris Investigator Site

Washington D.C., District of Columbia, 20037, United States

Location

Aclaris Investigator Site

Boynton Beach, Florida, 33472, United States

Location

Aclaris Investigator Site

Miami, Florida, 33136, United States

Location

Aclaris Investigator Site

Boston, Massachusetts, 02115, United States

Location

Aclaris Investigator Site

Clinton Township, Michigan, 48038, United States

Location

Aclaris Investigator Site

Warren, Michigan, 48088, United States

Location

Aclaris Investigator Site

Fridley, Minnesota, 55432, United States

Location

Aclaris Investigator Site

Minneapolis, Minnesota, 55455, United States

Location

Aclaris Investigator Site

Omaha, Nebraska, 68144, United States

Location

Aclaris Investigator Site

New York, New York, 10155, United States

Location

Aclaris Investigator Site

Durham, North Carolina, 27710, United States

Location

Aclaris Investigator Site

Winston-Salem, North Carolina, 27104, United States

Location

Aclaris Investigator Site

Portland, Oregon, 97210, United States

Location

Aclaris Investigator Site

Fort Washington, Pennsylvania, 19034, United States

Location

Aclaris Investigator Site

Knoxville, Tennessee, 37922, United States

Location

Aclaris Investigator Site

Nashville, Tennessee, 37215, United States

Location

Aclaris Investigator Site

Austin, Texas, 78745, United States

Location

Aclaris Investigator Site

Austin, Texas, 78759, United States

Location

Aclaris Investigator Site

San Antonio, Texas, 78229, United States

Location

Aclaris Investigator Site

San Antonio, Texas, 78745, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Marco Cardillo, Clinical Trial Manager
• Organization: Aclaris Therapeutics, Inc.

mcardillo@aclaristx.com

484-540-6299

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 28, 2017
• Study Start: November 29, 2017
• Primary Completion: April 18, 2019
• Study Completion: September 10, 2019
• Last Updated: June 5, 2020
• Results First Posted: June 5, 2020

Record last verified: 2020-05

Locations

US (23)