Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis

NCT04598269 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ATI-1777-AD-201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 14

Brief Summary

This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of participants with moderate or severe atopic dermatitis (AD).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4

  The EASI evaluation was performed by the Principal Investigator and evaluated atopic dermatitis in each of 3 body regions (trunk \[excluding groin and genitalia\], upper extremities \[excluding palms of hands\], and lower extremities \[excluding soles of feet\]). The EASI scoring system uses a defined process to grade the severity of the signs of atopic dermatitis and the extent affected. EASI Scores ranged from 0-72, with higher scores indicative of more severe disease.

  Baseline, Week 4

Secondary Outcomes (7)

• Percent Change From Baseline in EASI Score at Days 8 and 15

  Baseline, Days 8 and 15

• Number of Participants Who Achieve 50% Improvement in EASI Score (EASI 50) by Week 4

  Week 4

• Number of Participants Who Achieve 75% Improvement in EASI Score (EASI-75) by Week 4

  Week 4

• Number of Participants Who Achieve 90% Improvement in EASI Score (EASI-90) by Week 4

  Week 4

• Change From Baseline in Investigator Global Assessment (IGA) Score for Atopic Dermatitis at Days 8 and 15, and Week 4

  Baseline, Days 8 and 15, and Week 4

Study Arms (2)

ATI-1777

EXPERIMENTAL

ATI-1777 topical solution 2.0% w/w, twice daily

Drug: ATI-1777

Vehicle

PLACEBO COMPARATOR

Vehicle topical solution, twice daily

Drug: Vehicle

Interventions

ATI-1777 DRUG

ATI-1777 topical solution 2.0% w/w

ATI-1777

Vehicle DRUG

Vehicle topical solution containing no ATI-1777

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and willing to sign the IRB approved informed consent form (ICF) prior to administration of study-related procedures.
• Male patients or non-pregnant, non-nursing female patients 18 to 65 years old, inclusive, at the time of informed consent.
• Pregnancy and Contraception:
• Women of childbearing potential (WOCBP), must have a negative serum pregnancy test at the Screening Visit, a negative urine pregnancy test immediately prior to the first application of study medication on Day 1, and a negative urine pregnancy test at each study visit thereafter.
• WOCBP must agree to use 2 forms of highly effective contraception, including 1 physical barrier (condom or diaphragm) plus another highly effective method, such as adequate hormonal method (e.g., contraceptive implants, injectables, oral contraceptives) or nonhormonal methods (e.g., intrauterine device, spermicidals) throughout the Screening Period and until 30 days after the last administration of study medication.
• Male patients with partners of childbearing potential may be enrolled if they are:
• Documented to be surgically sterile (vasectomy), or
• Using 2 adequate forms of highly effective contraception, 1 of which should be a physical barrier until 90 days after the last administration of study medication.
• Have a diagnosis of AD fulfilling the specified diagnostic criteria of Hanifin and Rajka (Hanifin and Rajka 1980).
• 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.
• Have at least 1 lesion that measures at least 3 cm2 at the Screening Visit and on Day 1 prior to the first dose of study medication. This lesion must be representative of the patient's disease state, but not located on the hands, feet, or genitalia.
• Have a stable diagnosis of moderate or severe (IGA score 3 or 4) AD at the Screening Visit.
• Have AD affecting 3% to 20% BSA (not including scalp, face, palms of hands, soles of feet, groin, and genitalia) at the Screening Visit.
• Willing to refrain from washing area of treatment or swimming for 6 hours after each study medication application.
• Willing to refrain from excessive sun exposure (e.g., sunbathing and/or tanning salon visits) and to minimize sun exposure (e.g., wear sun protective clothing, hat) as much as possible.

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.
• Refractory AD (i.e., AD that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the Screening Visit).
• AD of a severity (EASI \>48) that the patient is not a candidate for a vehicle-controlled study.
• Any signs or symptoms associated with AD therapy (e.g., history of anaphylaxis, hypersensitivity reactions, skin atrophy, striae, pigmentary changes) that, in the investigator's opinion, might impair evaluation of the AD or which exposes the patient to unacceptable risk by study participation.
• 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.
• Use of any of the following treatments within the indicated washout period prior to Day 1:
• Phototherapy (ultraviolet A, ultraviolet B, or psoralen and ultraviolet A therapy) within 4 weeks prior to Day 1.
• Systemic biologic immunosuppressant or immunomodulatory therapy (e.g., etanercept, alefacept, infliximab, dupilumab) within 12 weeks (or 5 half-lives of the product, whichever is longer) prior to Day 1.
• Non-biologic immunosuppressants (e.g., methotrexate, retinoids, calcineurin inhibitors, cyclosporine, hydroxycarbamide \[hydroxyurea\], azathioprine) within 4 weeks prior to Day 1.
• Janus kinase (JAK) inhibitors (systemic and topical) within 4 weeks prior to Day 1.
• Systemic corticosteroids within 2 weeks prior to Day 1 (intranasal, inhaled, and topical ocular corticosteroids are allowed).
• Cytostatic agents within 4 weeks prior to Day 1.
• Crisaborole within 2 weeks prior to Day 1.
• Systemic antibiotics within 30 days prior to Day 1.
• Topical treatments for AD (corticosteroids, calcineurin inhibitors, topical H1 and H2 antihistamines, topical antimicrobials, and other medicated topical agents) within 2 weeks prior to Day 1.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (14)

Aclaris Investigational Site

Scottsdale, Arizona, 85260, United States

Location

Aclaris Investigational Site

Encino, California, 91436, United States

Location

Aclaris Investigational Site

Los Angeles, California, 90045, United States

Location

Aclaris Investigational Site

Tampa, Florida, 33613, United States

Location

Aclaris Investigational Site

Indianapolis, Indiana, 46250, United States

Location

Aclaris Investigational Site

Overland Park, Kansas, 66215, United States

Location

Aclaris Investigational Site

Omaha, Nebraska, 68144, United States

Location

Aclaris Investigational Site

Kew Gardens, New York, 11415, United States

Location

Aclaris Investigational Site

Newtown Square, Pennsylvania, 19073, United States

Location

Aclaris Investigational Site

Fountain Inn, South Carolina, 29644, United States

Location

Aclaris Investigational Site

Austin, Texas, 78759, United States

Location

Aclaris Investigational Site

San Antonio, Texas, 78213, United States

Location

Aclaris Investigational Site

Lynchburg, Virginia, 24501, United States

Location

Aclaris Investigational Site

Newport News, Virginia, 23606, United States

Location

Related Publications (1)

• Changelian P, Xu C, Mnich S, Hope H, Kostecki K, Hirsch J, Loh CY, Anderson D, Blinn J, Hockerman S, Dick E, Smith W, Monahan J, Raoof T, Forman S, Burt D, Barnes B, Gordon D, Walker N, Sudzina J, Tucker S, Jacobsen J. ATI-1777, a Topical Jak1/3 Inhibitor, May Benefit Atopic Dermatitis without Systemic Drug Exposure: Results from Preclinical Development and Phase 2a Randomized Control Study ATI-1777-AD-201. JID Innov. 2023 Nov 28;4(2):100251. doi: 10.1016/j.xjidi.2023.100251. eCollection 2024 Mar.

  PMID: 38299059 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Aclaris Therapeutics, Inc.

clinicaloperations@aclaristx.com

1-833-225-2747

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Vehicle-controlled, Parallel-group Study

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 22, 2020
• Study Start: September 30, 2020
• Primary Completion: April 8, 2021
• Study Completion: April 22, 2021
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Locations

US (14)