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ATI-1777 for Atopic Dermatitis

Phase 2
Waitlist Available
Research Sponsored by Aclaris Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 8 and 15, and week 4

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).

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 8 and 15, and week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 8 and 15, and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4
Secondary study objectives
Change From Baseline in Investigator Global Assessment (IGA) Score for Atopic Dermatitis at Days 8 and 15, and Week 4
Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Days 8 and 15, and Week 4
Change From Baseline in Percent of Body Surface Area (BSA) of Atopic Dermatitis at Days 8 and 15 and Week 4
+4 more
Other study objectives
Proportion of Subjects Experiencing a Shift from Baseline Laboratory Values
Summary of Abnormal Physical 12-lead ECG reading at Day 28
Summary of Abnormal Vital Signs at Day 15
+5 more

Side effects data

From 2021 Phase 2 trial • 50 Patients • NCT04598269
9%
Blood creatine phosphokinase increased
9%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATI-1777
Vehicle

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ATI-1777Experimental Treatment1 Intervention
ATI-1777 topical solution 2.0% w/w, twice daily
Group II: VehiclePlacebo Group1 Intervention
Vehicle topical solution, twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATI-1777
2020
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Aclaris Therapeutics, Inc.Lead Sponsor
34 Previous Clinical Trials
4,892 Total Patients Enrolled
~10 spots leftby Dec 2025
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