ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)

NCT03759340 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ATI-502-AA-203
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Alopecia Areata; Alopecia Universalis; Alopecia Totalis

Outcome Measures

Primary Outcomes (1)

• Change in the Severity of Alopecia Tool (SALT) Score

  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. For the primary endpoint, the primary efficacy variable was the mean relative percent change from the original baseline visit in study ATI-501-AUAT-201 and the SALT score at Week 24 on study ATI-502-AA-203. This represents the percentage of hair regrowth. It was calculated as the mean of the changes from baseline SALT score to the SALT score at Week 24, divided by baseline SALT score and expressed as a percentage.

  Baseline to Week 24

Secondary Outcomes (5)

• Mean Relative Percent Change From Baseline SALT Score

  Baseline to Week 24

• Proportion of Subjects Achieving a SALT50 (Defined as a ≥ 50% Improvement From Baseline in SALT) by Visit

  Baseline to Week 24

• Proportion of Subjects Achieving a SALT 75 (Defined as a ≥ 75% Improvement From Baseline in SALT) by Visit

  Baseline to Week 24

• Durability of Response

  Baseline to Week 24

• Change From Baseline in the Physician Global Impression of Severity (PhGIS)

  Baseline to Week 24

Study Arms (1)

ATI 502 0.46% Topical Solution

EXPERIMENTAL

Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.

Drug: ATI 502 0.46% Topical Solution

Interventions

ATI 502 0.46% Topical Solution DRUG

apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)

ATI 502 0.46% Topical Solution

Eligibility Criteria

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

You may qualify if:

• Subjects must meet the following criteria to be eligible for participation in the study:
• Subject must be able to comprehend and willing to sign the Informed Consent Form (ICF).
• Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed consent.
• Subject has completed 24 weeks of treatment and the assessments for Visit 9 in study ATI-501-AUAT-201.
• Subject has not experienced any AEs, SAEs or tolerability issues that met study discontinuation criteria in ATI-501-AUAT-201.
• Subject is capable of regrowing scalp hair or maintaining prior scalp hair regrowth from ATI-501-AUAT-201 in the opinion of the investigator.
• If a woman of childbearing potential (WOCBP), must have a negative urine pregnancy test at Visit 1 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. (Refer to Section 8.4).
• Be in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the subject or which might expose the subject to an unacceptable risk by study participation.
• Be willing to maintain the same general hair style throughout the study period. Subjects who shave their scalp must be willing to refrain from shaving their scalp for at least one week or longer prior to each study visit, as determined by the investigator based on visible scalp hair growth. Hair trimming outside the treatment areas to maintain the current hair style is permitted.
• Be willing and able to follow all study instructions and to attend all study visits.
• Sexually active male subjects must agree to use a barrier method of contraception from the first application of study medication to at least 30 days after the last application of study medication.

You may not qualify if:

• Subjects are excluded from this study if any 1 or more of the following criteria is met:
• Any study medication discontinuation criteria are met during participation in study ATI-501-AUAT-201.
• 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.
• 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.
• Sensitivity to any of the ingredients in the study medications.
• Unwillingness to refrain from weaves, hair extensions, or shaving of the scalp for at least one week or longer prior to each study visit, as determined by the investigator based on visible scalp hair growth the duration of the study.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (20)

Aclaris Investigator Site

Rogers, Arkansas, 72758, United States

Location

Aclaris Investigator Site

Denver, Colorado, 80210, United States

Location

Aclaris Investigator Site

Boynton Beach, Florida, 33472, United States

Location

Aclaris Investigator Site

Snellville, Georgia, 30078, United States

Location

Aclaris Investigator Site

Clinton Township, Michigan, 48038, United States

Location

Aclaris Investigator SIte

Detroit, Michigan, 48202, United States

Location

Aclaris Investigator Site

Fridley, Minnesota, 55432, United States

Location

Aclaris Investigator Site

Minneapolis, Minnesota, 55455, United States

Location

Aclaris Investigator Site

Saint Joseph, Missouri, 64506, United States

Location

Aclaris Investigator Site

Omaha, Nebraska, 68144, United States

Location

Aclaris Investigator Site

Las Vegas, Nevada, 89148, United States

Location

Aclaris Investigator Site

New York, New York, 10075, United States

Location

Aclaris Investigator Site

Rochester, New York, 14623, United States

Location

Aclaris Investigator Site

Portland, Oregon, 97223, United States

Location

Aclaris Investigator Site

Greenville, South Carolina, 29607, United States

Location

Aclaris Investigator Site

Knoxville, Tennessee, 37922, United States

Location

Aclaris Investigational Site

Nashville, Tennessee, 37215, United States

Location

Aclaris Investigational Site

Austin, Texas, 78745, United States

Location

Aclaris Investigator Site

Houston, Texas, 77056, United States

Location

Aclaris Investigator Site

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Interventions

Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Limitations and Caveats

The ATI-502-AA-203 study was terminated early due to lack of efficacy in a similarly designed study with ATI-502 Topical Solution. Due to the premature termination, the secondary efficacy analyses outlined in the protocol were not performed.

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 30, 2018
• Study Start: January 15, 2019
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: October 6, 2020
• Results First Posted: September 17, 2020

Record last verified: 2020-09

Locations

US (20)