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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05432596
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

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 moderate or severe Atopic Dermatitis. Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 weeks.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ATI-1777 2.0% w/w Drug: ATI-1777 1.0% w/w Drug: ATI-1777 0.5% w/w Drug: Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-blind, Vehicle-controlled, Parallel-group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Moderate or Severe Atopic Dermatitis (AD)
Actual Study Start Date : May 11, 2022
Estimated Primary Completion Date : March 23, 2023
Estimated Study Completion Date : April 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage change from baseline in EASI score at each post-baseline study visit [ Time Frame: Baseline to Day 42 ]
  2. 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.

  3. 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 ]
  4. Change from baseline in vIGA score at each post-baseline study visit [ Time Frame: Baseline to Day 42 ]
  5. 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

  6. 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.

  7. 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



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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05432596


Contacts
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Contact: Marco Cardillo 1-484-540-6299 clinicaloperations@aclaristx.com
Contact: Rob Ortmann 1-484-324-7933 clinicaloperations@aclaristx.com

Locations
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United States, Alabama
Aclaris Investigational Site Recruiting
Birmingham, Alabama, United States, 35244
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Arkansas
Aclaris Investigational Site Recruiting
Bryant, Arkansas, United States, 72022
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
North Little Rock, Arkansas, United States, 72117
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, California
Aclaris Investigational Site Recruiting
Encinitas, California, United States, 92024
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Encino, California, United States, 91436
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Colorado
Aclaris Investigational Site Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Florida
Aclaris Investigational Site Recruiting
Delray Beach, Florida, United States, 33484
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Miami Lakes, Florida, United States, 33014
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Miami, Florida, United States, 33173
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Tampa, Florida, United States, 33613
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Georgia
Aclaris Investigational Site Recruiting
Marietta, Georgia, United States, 30060
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Sandy Springs, Georgia, United States, 30328
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Illinois
Aclaris Investigational Site Recruiting
Normal, Illinois, United States, 61761
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Skokie, Illinois, United States, 60077
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Indiana
Aclaris Investigational Site Recruiting
Indianapolis, Indiana, United States, 46250
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Louisiana
Aclaris Investigational Site Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Houma, Louisiana, United States, 70364
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Missouri
Aclaris Investigational Site Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, North Carolina
Aclaris Investigational Site Recruiting
High Point, North Carolina, United States, 27262
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Wilmington, North Carolina, United States, 28405
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Oklahoma
Aclaris Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73118
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Oregon
Aclaris Investigational Site Recruiting
Medford, Oregon, United States, 97504
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, South Carolina
Aclaris Investigational Site Recruiting
Greenville, South Carolina, United States, 29615
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Tennessee
Aclaris Investigational Site Recruiting
Murfreesboro, Tennessee, United States, 37130
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Texas
Aclaris Investigational Site Recruiting
Arlington, Texas, United States, 76011
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Dallas, Texas, United States, 75230
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
Houston, Texas, United States, 77004
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Aclaris Investigational Site Recruiting
San Antonio, Texas, United States, 78213
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
United States, Virginia
Aclaris Investigational Site Recruiting
Richmond, Virginia, United States, 23233
Contact: Aclaris Clinical Operations    484-324-7933    clintrials@aclaristx.com   
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
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Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05432596    
Other Study ID Numbers: ATI-1777-AD-202
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases