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

Atopic Dermatitis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432596
• Other study ID #: ATI-1777-AD-202
• Status: Completed
• Phase: Phase 2
• Start date: May 11, 2022
• Est. completion date: November 14, 2023

Study information

• Verified date: December 2023
• Source: Aclaris Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 14, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• ATI-1777 2.0% w/w
ATI-1777 topical solution 2.0% w/w
• ATI-1777 1.0% w/w
ATI-1777 topical solution 1.0% w/w
• ATI-1777 0.5% w/w
ATI-1777 topical solution 0.5% w/w
• Vehicle
Vehicle topical solution

Locations

Country	Name	City	State
United States	Aclaris Investigational Site	Arlington	Texas
United States	Aclaris Investigational Site	Baton Rouge	Louisiana
United States	Aclaris Investigational Site	Birmingham	Alabama
United States	Aclaris Investigational Site	Bryant	Arkansas
United States	Aclaris Investigational Site	Castle Rock	Colorado
United States	Aclaris Investigational Site	Colorado Springs	Colorado
United States	Aclaris Investigational Site	Dallas	Texas
United States	Aclaris Investigational Site	Delray Beach	Florida
United States	Aclaris Investigational Site	Encinitas	California
United States	Aclaris Investigational Site	Encino	California
United States	Aclaris Investigational Site	Greenville	South Carolina
United States	Aclaris Investigational Site	Houma	Louisiana
United States	Aclaris Investigational Site	Houston	Texas
United States	Aclaris Investigational Site	Indianapolis	Indiana
United States	Aclaris Investigational Site	Medford	Oregon
United States	Aclaris Investigational Site	Miami	Florida
United States	Aclaris Investigational Site	Miami Lakes	Florida
United States	Aclaris Investigational Site	Murfreesboro	Tennessee
United States	Aclaris Investigational Site	New Albany	Indiana
United States	Aclaris Investigational Site	Normal	Illinois
United States	Aclaris Investigational Site	North Little Rock	Arkansas
United States	Aclaris Investigational Site	Oklahoma City	Oklahoma
United States	Aclaris Investigational Site	Richmond	Virginia
United States	Aclaris Investigational Site	Saint Joseph	Missouri
United States	Aclaris Investigational Site	San Antonio	Texas
United States	Aclaris Investigational Site	Sandy Springs	Georgia
United States	Aclaris Investigational Site	Scottsdale	Arizona
United States	Aclaris Investigational Site	Skokie	Illinois
United States	Aclaris Investigational Site	Tampa	Florida
United States	Aclaris Investigational Site	West Lafayette	Indiana
United States	Aclaris Investigational Site	West Palm Beach	Florida
United States	Aclaris Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aclaris Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage change from baseline in EASI score at each post-baseline study visit		Baseline to Day 42
Secondary	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
Secondary	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
Secondary	Change from baseline in vIGA score at each post-baseline study visit		Baseline to Day 42
Secondary	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
Secondary	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
Secondary	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