NCT05432596

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

A Phase 2b, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (AD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	ATI-1777 2.0% w/w	ATI-1777 topical solution 2.0% w/w
DRUG	ATI-1777 1.0% w/w	ATI-1777 topical solution 1.0% w/w
DRUG	ATI-1777 0.5% w/w	ATI-1777 topical solution 0.5% w/w
DRUG	Vehicle	Vehicle topical solution

Timeline

• Start date: 2022-05-11
• Primary completion: 2023-10-26
• Completion: 2023-11-14
• First posted: 2022-06-27
• Last updated: 2024-10-26

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study