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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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).

Key facts

Study ID: NCT04598269
Run by: Aclaris Therapeutics, Inc.
People needed: 50
Starts: 2020-09-30
Expected to finish: 2021-04-22
Last updated by the study team: 2023-09-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
Willing to refrain from use of moisturizers, emollients, and sunscreen on AD study treatment areas for duration of protocol therapy.
Willing to refrain from participating in strenuous exercise that would cause profuse sweating for a period of 6 hours after each study medication application.
Willing to return to the clinic, follow all study instructions, attend all study visits, and complete study procedures.
In good general health and free of any known disease state or physical condition that, in the investigator's opinion, might impair evaluation of the patient or that might expose the patient to an unacceptable risk by study participation.
Willing and capable of taking appropriate coronavirus disease 2019 (COVID-19) risk mitigation precautions (e.g., wearing a mask in public, adhering to social distancing, etc.) as recommended or required by local, state, or federal guidelines during participation in the study.

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.
Live attenuated vaccine treatment within 12 weeks prior to Day 1.
Other investigational product within 30 days or 5 half-lives (whichever is longer) prior to Day 1.
Previous failure to respond to prior therapy with JAK inhibitors (systemic or topical), as determined by the investigator.
Current use of an oral H1 antihistamine (e.g., diphenhydramine, terfenadine) unless the patient is on a stable dose for at least 14 days prior to the Screening Visit.
Medical marijuana unless the patient is on a stable dose for at least 14 days prior to the Screening Visit.
Clinically significant laboratory abnormalities at the Screening Visit that, in the opinion of the investigator, could affect interpretation of study data or the safety of the patient's participation in the study.
Clinical laboratory values:
White blood cell count <2×109/L
Absolute neutrophil count (ANC) <1800/mL
Platelet count <130,000/mL

Where it is running

Aclaris Investigational Site — Scottsdale, Arizona, United States
Aclaris Investigational Site — Encino, California, United States
Aclaris Investigational Site — Los Angeles, California, United States
Aclaris Investigational Site — Tampa, Florida, United States
Aclaris Investigational Site — Indianapolis, Indiana, United States
Aclaris Investigational Site — Overland Park, Kansas, United States
Aclaris Investigational Site — Omaha, Nebraska, United States
Aclaris Investigational Site — Kew Gardens, New York, United States
Aclaris Investigational Site — Newtown Square, Pennsylvania, United States
Aclaris Investigational Site — Fountain Inn, South Carolina, United States
Aclaris Investigational Site — Austin, Texas, United States
Aclaris Investigational Site — San Antonio, Texas, United States
Aclaris Investigational Site — Lynchburg, Virginia, United States
Aclaris Investigational Site — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.