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

September 17, 2020 updated by: Aclaris Therapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Subjects who complete 24 weeks of active treatment with ATI-501 Oral Suspension or Placebo Suspension in study ATI-501-AUAT-201 will be assessed for eligibility to enter the study. At Visit 9 in study ATI-501-AUAT-201, subjects who did not experience any adverse events (AEs), serious adverse events (SAEs), or tolerability issues that met study discontinuation criteria in study ATI-501-AUAT-201 and who in the opinion of the investigator are capable of re-growing or maintaining scalp hair and meet the entry criteria are eligible to enroll in this open-label study.

Enrolled subjects will apply ATI-502 Topical Solution, 0.46% BID to the entire scalp and if applicable, the eyebrow(s) and return for safety and efficacy assessments as detailed in the Schedule of Assessments (Table 3). Assessment of response to treatment will be performed at Week 4, Week 8, Week 16, Week 24, and post-treatment Week 28. Safety and tolerability will be evaluated at each study visit by assessment of adverse events, clinical laboratory tests, and vital signs, and at Week 24, and physical examination findings

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Aclaris Investigator Site
    • Colorado
      • Denver, Colorado, United States, 80210
        • Aclaris Investigator Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Aclaris Investigator Site
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Aclaris Investigator Site
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Aclaris Investigator Site
      • Detroit, Michigan, United States, 48202
        • Aclaris Investigator Site
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Aclaris Investigator Site
      • Minneapolis, Minnesota, United States, 55455
        • Aclaris Investigator Site
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Aclaris Investigator Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Aclaris Investigator Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Aclaris Investigator Site
    • New York
      • New York, New York, United States, 10075
        • Aclaris Investigator Site
      • Rochester, New York, United States, 14623
        • Aclaris Investigator Site
    • Oregon
      • Portland, Oregon, United States, 97223
        • Aclaris Investigator Site
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Aclaris Investigator Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Aclaris Investigator Site
      • Nashville, Tennessee, United States, 37215
        • Aclaris Investigational Site
    • Texas
      • Austin, Texas, United States, 78745
        • Aclaris Investigational Site
      • Houston, Texas, United States, 77056
        • Aclaris Investigator Site
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Aclaris Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must meet the following criteria to be eligible for participation in the study:

    1. Subject must be able to comprehend and willing to sign the Informed Consent Form (ICF).
    2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed consent.
    3. Subject has completed 24 weeks of treatment and the assessments for Visit 9 in study ATI-501-AUAT-201.
    4. Subject has not experienced any AEs, SAEs or tolerability issues that met study discontinuation criteria in ATI-501-AUAT-201.
    5. Subject is capable of regrowing scalp hair or maintaining prior scalp hair regrowth from ATI-501-AUAT-201 in the opinion of the investigator.
    6. 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).
    7. 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.
    8. 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.
    9. Be willing and able to follow all study instructions and to attend all study visits.
    10. 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.

Exclusion Criteria:

  • Subjects are excluded from this study if any 1 or more of the following criteria is met:

    1. Any study medication discontinuation criteria are met during participation in study ATI-501-AUAT-201.
    2. 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.
    3. 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.
    4. Sensitivity to any of the ingredients in the study medications.
    5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ATI 502 0.46% Topical Solution
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
apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the Severity of Alopecia Tool (SALT) Score
Time Frame: Baseline to 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. 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Relative Percent Change From Baseline SALT Score
Time Frame: Baseline to Week 24
Mean Relative Percent Change from Baseline (from the current study ATI-502-AA-203) in Severity of Alopecia Tool (SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A lower SALT score is a better outcome. A higher relative percent change is better.
Baseline to Week 24
Proportion of Subjects Achieving a SALT50 (Defined as a ≥ 50% Improvement From Baseline in SALT) by Visit
Time Frame: Baseline to Week 24
Proportion of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT) by visit 6. SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
Baseline to Week 24
Proportion of Subjects Achieving a SALT 75 (Defined as a ≥ 75% Improvement From Baseline in SALT) by Visit
Time Frame: Baseline to Week 24
Proportion of subjects achieving SALT 75 (defined as a ≥ 75% improvement from baseline in SALT) by visit 6 SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A bigger percent change is a more positive score.
Baseline to Week 24
Durability of Response
Time Frame: Baseline to Week 24
Durability of response: Proportion of subjects achieving a SALT 50 or SALT 75 at Week 24 (in study ATI-501-AUAT-201) and maintaining that response at week 24 in ATI-502-AA-203 study.
Baseline to Week 24
Change From Baseline in the Physician Global Impression of Severity (PhGIS)
Time Frame: Baseline to Week 24
Change from Baseline in the PhGIS by visit. The PhGIS is a 5 point scale from Mild to Extremely Severe. Mild is a better outcome.
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aclaris Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATI-502-AA-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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