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

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: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Vehicle; Drug: ATI-1777 2.0% w/w; Drug: ATI-1777 1.0% w/w; Drug: ATI-1777 0.5% w/w

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (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

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in EASI score at each post-baseline study visit		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.	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		Baseline to Day 42
Change from baseline in vIGA score at each post-baseline study visit		Baseline to Day 42
Change from baseline in Body Surface Area (BSA) at each post-baseline study visit	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	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	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

• Sponsor: Aclaris Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): November 14, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID 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