Status:
COMPLETED
Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Aclaris Therapeutics, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.
Detailed Description
This open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficac...
Eligibility Criteria
Inclusion
- 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 18 to 60 years old, inclusive, at the time of informed consent/assent.
- Have at least a 1-year history of moderate or severe AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit as determined by the Investigator upon review of participant medical history.
Exclusion
- Any prior exposure to systemic (oral) JAK inhibitors or TYK inhibitors at any time prior to Screening.
- 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 (ie, AD that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the Screening Visit).
- 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.
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06585202
Start Date
August 19 2024
End Date
March 27 2025
Last Update
April 29 2025
Active Locations (6)
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1
Aclaris Investigational Site
Birmingham, Alabama, United States, 35244
2
Aclaris Investigational Site
Encino, California, United States, 91436
3
Aclaris Investigational Site
San Diego, California, United States, 92123
4
Aclaris Investigational Site
Plainfield, Indiana, United States, 46168