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)
1 other identifier
interventional
250
1 country
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2022
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2022
CompletedFirst Submitted
Initial submission to the registry
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2023
CompletedOctober 26, 2024
October 1, 2024
1.5 years
June 1, 2022
October 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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.
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
Baseline to Day 42
- +2 more secondary outcomes
Study Arms (6)
ATI-1777 topical solution 2.0% w/w (BID)
EXPERIMENTALATI-1777 topical solution 2.0% w/w, twice daily
ATI-1777 topical solution 1.0% w/w (BID)
EXPERIMENTALATI-1777 topical solution 1.0% w/w, twice daily
ATI-1777 topical solution 0.5% w/w (BID)
EXPERIMENTALATI-1777 topical solution 0.5% w/w, twice daily
Vehicle (BID)
PLACEBO COMPARATORVehicle topical solution, twice daily
ATI-1777 topical solution 2.0% w/w (QD)
EXPERIMENTALATI-1777 topical solution 2.0% w/w, once daily
Vehicle (QD)
PLACEBO COMPARATORVehicle topical solution, once daily
Interventions
ATI-1777 topical solution 2.0% w/w
Eligibility Criteria
You may qualify if:
- Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.
- Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent.
- 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.
You may not qualify if:
- Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
- 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.
- Female patients who are pregnant, nursing, or planning to become pregnant during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Aclaris Investigational Site
Birmingham, Alabama, 35244, United States
Aclaris Investigational Site
Scottsdale, Arizona, 85255, United States
Aclaris Investigational Site
Bryant, Arkansas, 72022, United States
Aclaris Investigational Site
North Little Rock, Arkansas, 72117, United States
Aclaris Investigational Site
Encinitas, California, 92024, United States
Aclaris Investigational Site
Encino, California, 91436, United States
Aclaris Investigational Site
Castle Rock, Colorado, 80109, United States
Aclaris Investigational Site
Colorado Springs, Colorado, 80907, United States
Aclaris Investigational Site
Delray Beach, Florida, 33484, United States
Aclaris Investigational Site
Miami, Florida, 33173, United States
Aclaris Investigational Site
Miami Lakes, Florida, 33014, United States
Aclaris Investigational Site
Tampa, Florida, 33613, United States
Aclaris Investigational Site
West Palm Beach, Florida, 33401, United States
Aclaris Investigational Site
Sandy Springs, Georgia, 30328, United States
Aclaris Investigational Site
Normal, Illinois, 61761, United States
Aclaris Investigational Site
Skokie, Illinois, 60077, United States
Aclaris Investigational Site
Indianapolis, Indiana, 46250, United States
Aclaris Investigational Site
New Albany, Indiana, 47150, United States
Aclaris Investigational Site
West Lafayette, Indiana, 47906, United States
Aclaris Investigational Site
Baton Rouge, Louisiana, 70809, United States
Aclaris Investigational Site
Houma, Louisiana, 70364, United States
Aclaris Investigational Site
Saint Joseph, Missouri, 64506, United States
Aclaris Investigational Site
Wilmington, North Carolina, 28405, United States
Aclaris Investigational Site
Oklahoma City, Oklahoma, 73118, United States
Aclaris Investigational Site
Medford, Oregon, 97504, United States
Aclaris Investigational Site
Greenville, South Carolina, 29615, United States
Aclaris Investigational Site
Murfreesboro, Tennessee, 37130, United States
Aclaris Investigational Site
Arlington, Texas, 76011, United States
Aclaris Investigational Site
Dallas, Texas, 75230, United States
Aclaris Investigational Site
Houston, Texas, 77004, United States
Aclaris Investigational Site
San Antonio, Texas, 78213, United States
Aclaris Investigational Site
Richmond, Virginia, 23233, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2022
First Posted
June 27, 2022
Study Start
May 11, 2022
Primary Completion
October 26, 2023
Study Completion
November 14, 2023
Last Updated
October 26, 2024
Record last verified: 2024-10