NCT04598269

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

A Phase 2a, Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Participants underwent screening evaluations to determine eligibility up to 30 days prior to randomization. Participants who meet all the entry criteria were randomized on Day 1 to active or vehicle treatment. Participants applied study drug (ATI-1777 topical solution 2.0% w/w or vehicle) twice daily for 4 weeks with weekly study visits and were to return 2 weeks after the last dose of study medication for a Post treatment Follow-up (PTFU) Visit.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	ATI-1777	ATI-1777 topical solution 2.0% w/w
DRUG	Vehicle	Vehicle topical solution containing no ATI-1777

Timeline

• Start date: 2020-09-30
• Primary completion: 2021-04-08
• Completion: 2021-04-22
• First posted: 2020-10-22
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study