Status:
COMPLETED
Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis
Lead Sponsor:
Aclaris Therapeutics, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
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 participan...
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 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
- 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.
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05432596
Start Date
May 11 2022
End Date
November 14 2023
Last Update
October 26 2024
Active Locations (32)
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1
Aclaris Investigational Site
Birmingham, Alabama, United States, 35244
2
Aclaris Investigational Site
Scottsdale, Arizona, United States, 85255
3
Aclaris Investigational Site
Bryant, Arkansas, United States, 72022
4
Aclaris Investigational Site
North Little Rock, Arkansas, United States, 72117