Back to resultsStudy of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATI-1777 2.0% w/w
ATI-1777 1.0% w/w
ATI-1777 0.5% w/w
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
- Aclaris Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
ATI-1777 topical solution 2.0% w/w (BID)
ATI-1777 topical solution 1.0% w/w (BID)
ATI-1777 topical solution 0.5% w/w (BID)
Vehicle (BID)
ATI-1777 topical solution 2.0% w/w (QD)
Vehicle (QD)
Arm Description
ATI-1777 topical solution 2.0% w/w, twice daily
ATI-1777 topical solution 1.0% w/w, twice daily
ATI-1777 topical solution 0.5% w/w, twice daily
Vehicle topical solution, twice daily
ATI-1777 topical solution 2.0% w/w, once daily
Vehicle topical solution, once daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage change from baseline in EASI score at each post-baseline study visit
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.
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
Change from baseline in vIGA score at each post-baseline study visit
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
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.
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
Full Information
NCT ID
NCT05432596
First Posted
June 1, 2022
Last Updated
October 4, 2023
Sponsor
Aclaris Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05432596
Brief Title
Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
October 26, 2023 (Anticipated)
Study Completion Date
November 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aclaris Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind, Vehicle-controlled, Parallel-group Study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATI-1777 topical solution 2.0% w/w (BID)
Arm Type
Experimental
Arm Description
ATI-1777 topical solution 2.0% w/w, twice daily
Arm Title
ATI-1777 topical solution 1.0% w/w (BID)
Arm Type
Experimental
Arm Description
ATI-1777 topical solution 1.0% w/w, twice daily
Arm Title
ATI-1777 topical solution 0.5% w/w (BID)
Arm Type
Experimental
Arm Description
ATI-1777 topical solution 0.5% w/w, twice daily
Arm Title
Vehicle (BID)
Arm Type
Placebo Comparator
Arm Description
Vehicle topical solution, twice daily
Arm Title
ATI-1777 topical solution 2.0% w/w (QD)
Arm Type
Experimental
Arm Description
ATI-1777 topical solution 2.0% w/w, once daily
Arm Title
Vehicle (QD)
Arm Type
Placebo Comparator
Arm Description
Vehicle topical solution, once daily
Intervention Type
Drug
Intervention Name(s)
ATI-1777 2.0% w/w
Intervention Description
ATI-1777 topical solution 2.0% w/w
Intervention Type
Drug
Intervention Name(s)
ATI-1777 1.0% w/w
Intervention Description
ATI-1777 topical solution 1.0% w/w
Intervention Type
Drug
Intervention Name(s)
ATI-1777 0.5% w/w
Intervention Description
ATI-1777 topical solution 0.5% w/w
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle topical solution
Primary Outcome Measure Information:
Title
Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
Description
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.
Time Frame
Baseline to Day 28
Secondary Outcome Measure Information:
Title
Percentage change from baseline in EASI score at each post-baseline study visit
Time Frame
Baseline to Day 42
Title
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.
Description
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.
Time Frame
Baseline to Day 42
Title
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
Title
Change from baseline in vIGA score at each post-baseline study visit
Time Frame
Baseline to Day 42
Title
Change from baseline in Body Surface Area (BSA) at each post-baseline study visit
Description
BSA is defined as a percentage of the total body (0-100) that is affected by disease
Time Frame
Baseline to Day 42
Title
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
Description
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.
Time Frame
Baseline to Day 42
Title
Change from baseline in Itch Numerical Rating Scale (PP NRS) from baseline to Day 28
Description
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
Time Frame
Baseline to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Aclaris Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Aclaris Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Aclaris Investigational Site
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Aclaris Investigational Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Aclaris Investigational Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Aclaris Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Aclaris Investigational Site
City
Castle Rock
State/Province
Colorado
ZIP/Postal Code
80109
Country
United States
Facility Name
Aclaris Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Aclaris Investigational Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Aclaris Investigational Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Aclaris Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Aclaris Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Aclaris Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Aclaris Investigational Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Aclaris Investigational Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Aclaris Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Aclaris Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Aclaris Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Aclaris Investigational Site
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Facility Name
Aclaris Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Aclaris Investigational Site
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70364
Country
United States
Facility Name
Aclaris Investigational Site
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Aclaris Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Aclaris Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Aclaris Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Aclaris Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Aclaris Investigational Site
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Aclaris Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Aclaris Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Aclaris Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Aclaris Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Aclaris Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis
We'll reach out to this number within 24 hrs