Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis

October 24, 2024 updated by: Aclaris Therapeutics, Inc.

A Phase 2b, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (AD)

This is a Phase 2b study to determine the safety, tolerability, pharmacokinetic (PK), and efficacy of ATI-1777 in patients 12 to 65 years old with mild to severe Atopic Dermatitis. Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 weeks.

Study Overview

Status

Status

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

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.

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.
250

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Aclaris Investigational Site
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Aclaris Investigational Site
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Aclaris Investigational Site
      • North Little Rock, Arkansas, United States, 72117
        • Aclaris Investigational Site
    • California
      • Encinitas, California, United States, 92024
        • Aclaris Investigational Site
      • Encino, California, United States, 91436
        • Aclaris Investigational Site
    • Colorado
      • Castle Rock, Colorado, United States, 80109
        • Aclaris Investigational Site
      • Colorado Springs, Colorado, United States, 80907
        • Aclaris Investigational Site
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Aclaris Investigational Site
      • Miami, Florida, United States, 33173
        • Aclaris Investigational Site
      • Miami Lakes, Florida, United States, 33014
        • Aclaris Investigational Site
      • Tampa, Florida, United States, 33613
        • Aclaris Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Aclaris Investigational Site
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Aclaris Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Aclaris Investigational Site
      • Skokie, Illinois, United States, 60077
        • Aclaris Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Aclaris Investigational Site
      • New Albany, Indiana, United States, 47150
        • Aclaris Investigational Site
      • West Lafayette, Indiana, United States, 47906
        • Aclaris Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Aclaris Investigational Site
      • Houma, Louisiana, United States, 70364
        • Aclaris Investigational Site
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Aclaris Investigational Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28405
        • Aclaris Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Aclaris Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Aclaris Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Aclaris Investigational Site
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Aclaris Investigational Site
    • Texas
      • Arlington, Texas, United States, 76011
        • Aclaris Investigational Site
      • Dallas, Texas, United States, 75230
        • Aclaris Investigational Site
      • Houston, Texas, United States, 77004
        • Aclaris Investigational Site
      • San Antonio, Texas, United States, 78213
        • Aclaris Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23233
        • Aclaris Investigational 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

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.
  2. Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent.
  3. Have at least a 6-month history of AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit.

Exclusion Criteria:

  1. Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
  2. Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments.
  3. Female patients who are pregnant, nursing, or planning to become pregnant during 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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-1777 topical solution 2.0% w/w (BID)
ATI-1777 topical solution 2.0% w/w, twice daily
Drug: ATI-1777 2.0% w/w
ATI-1777 topical solution 2.0% w/w
Experimental: ATI-1777 topical solution 1.0% w/w (BID)
ATI-1777 topical solution 1.0% w/w, twice daily
Drug: ATI-1777 1.0% w/w
ATI-1777 topical solution 1.0% w/w
Experimental: ATI-1777 topical solution 0.5% w/w (BID)
ATI-1777 topical solution 0.5% w/w, twice daily
Drug: ATI-1777 0.5% w/w
ATI-1777 topical solution 0.5% w/w
Placebo Comparator: Vehicle (BID)
Vehicle topical solution, twice daily
Drug: Vehicle
Vehicle topical solution
Experimental: ATI-1777 topical solution 2.0% w/w (QD)
ATI-1777 topical solution 2.0% w/w, once daily
Drug: ATI-1777 2.0% w/w
ATI-1777 topical solution 2.0% w/w
Placebo Comparator: Vehicle (QD)
Vehicle topical solution, once daily
Drug: Vehicle
Vehicle topical solution

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
Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
Time Frame: Baseline to Day 28
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Baseline to Day 28

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
Percentage change from baseline in EASI score at each post-baseline study visit
Time Frame: Baseline to Day 42
Baseline to Day 42
Proportion achieving Investigator's Global Assessment-Treatment Success (IGA-TS) defined as Validated Investigator Global Assessment (vIGA) score of 0 or 1 with an improvement in vIGA of at least 2 points from baseline at each post-baseline study visit.
Time Frame: Baseline to Day 42
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Baseline to Day 42
Proportion of patients who achieve 50%, 75%, and 90% improvement in EASI score (EASI 50, EASI 75, and EASI 90, respectively) at each post-baseline study visit
Time Frame: Baseline to Day 42
Baseline to Day 42
Change from baseline in vIGA score at each post-baseline study visit
Time Frame: Baseline to Day 42
Baseline to Day 42
Change from baseline in Body Surface Area (BSA) at each post-baseline study visit
Time Frame: Baseline to Day 42
BSA is defined as a percentage of the total body (0-100) that is affected by disease
Baseline to Day 42
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
Time Frame: Baseline to Day 42
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.
Baseline to Day 42
Change from baseline in Itch Numerical Rating Scale (PP NRS) from baseline to Day 28
Time Frame: Baseline to Day 28
The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.study visit
Baseline to Day 28

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.
May 11, 2022

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.
October 26, 2023

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.
November 14, 2023

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).
June 1, 2022

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.
June 20, 2022

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.
June 27, 2022

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 26, 2024

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.
October 24, 2024

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.
October 1, 2024

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-1777-AD-202

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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