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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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 participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 weeks.

Key facts

Study ID

NCT05432596

Run by

Aclaris Therapeutics, Inc.

People needed

250

Starts

2022-05-11

Expected to finish

2023-11-14

Last updated by the study team

2024-10-26

Who can join

Age: 12 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 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.

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.
• 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.

Where it is running

• Aclaris Investigational Site — Birmingham, Alabama, United States
• Aclaris Investigational Site — Scottsdale, Arizona, United States
• Aclaris Investigational Site — Bryant, Arkansas, United States
• Aclaris Investigational Site — North Little Rock, Arkansas, United States
• Aclaris Investigational Site — Encinitas, California, United States
• Aclaris Investigational Site — Encino, California, United States
• Aclaris Investigational Site — Castle Rock, Colorado, United States
• Aclaris Investigational Site — Colorado Springs, Colorado, United States
• Aclaris Investigational Site — Delray Beach, Florida, United States
• Aclaris Investigational Site — Miami, Florida, United States
• Aclaris Investigational Site — Miami Lakes, Florida, United States
• Aclaris Investigational Site — Tampa, Florida, United States
• Aclaris Investigational Site — West Palm Beach, Florida, United States
• Aclaris Investigational Site — Sandy Springs, Georgia, United States
• Aclaris Investigational Site — Normal, Illinois, United States
• Aclaris Investigational Site — Skokie, Illinois, United States
• Aclaris Investigational Site — Indianapolis, Indiana, United States
• Aclaris Investigational Site — New Albany, Indiana, United States
• Aclaris Investigational Site — West Lafayette, Indiana, United States
• Aclaris Investigational Site — Baton Rouge, Louisiana, United States
• Aclaris Investigational Site — Houma, Louisiana, United States
• Aclaris Investigational Site — Saint Joseph, Missouri, United States
• Aclaris Investigational Site — Wilmington, North Carolina, United States
• Aclaris Investigational Site — Oklahoma City, Oklahoma, United States
• Aclaris Investigational Site — Medford, Oregon, United States

Full record on ClinicalTrials.gov

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