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Topical Agent
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 42
Summary
This trial tests a skin-applied medication called ATI-1777 in patients aged 12 to 65 with mild to severe Atopic Dermatitis. The goal is to see if it is safe and effective in reducing their symptoms.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 42
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 42
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)
Secondary study objectives
Change from baseline in Body Surface Area (BSA) at each post-baseline study visit
Change from baseline in Itch Numerical Rating Scale (PP NRS) from baseline to Day 28
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: ATI-1777 topical solution 2.0% w/w (QD)Experimental Treatment1 Intervention
ATI-1777 topical solution 2.0% w/w, once daily
Group II: ATI-1777 topical solution 2.0% w/w (BID)Experimental Treatment1 Intervention
ATI-1777 topical solution 2.0% w/w, twice daily
Group III: ATI-1777 topical solution 1.0% w/w (BID)Experimental Treatment1 Intervention
ATI-1777 topical solution 1.0% w/w, twice daily
Group IV: ATI-1777 topical solution 0.5% w/w (BID)Experimental Treatment1 Intervention
ATI-1777 topical solution 0.5% w/w, twice daily
Group V: Vehicle (BID)Placebo Group1 Intervention
Vehicle topical solution, twice daily
Group VI: Vehicle (QD)Placebo Group1 Intervention
Vehicle topical solution, once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATI-1777 1.0% w/w
2022
Completed Phase 2
~250
ATI-1777 2.0% w/w
2022
Completed Phase 2
~250
ATI-1777 0.5% w/w
2022
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Aclaris Therapeutics, Inc.Lead Sponsor
34 Previous Clinical Trials
4,692 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are male or female, aged 12 to 65 years, inclusive, at the time of informed consent/assent.Your Alzheimer's disease has been rapidly getting worse or better recently, as determined by your doctor.You have a skin condition that could affect the study assessments or an infection in the area where the study drug will be applied.You 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 are able to comprehend and willing to sign the ICF/assent prior to study-related procedures.
Research Study Groups:
This trial has the following groups:- Group 1: ATI-1777 topical solution 2.0% w/w (BID)
- Group 2: ATI-1777 topical solution 1.0% w/w (BID)
- Group 3: ATI-1777 topical solution 0.5% w/w (BID)
- Group 4: Vehicle (BID)
- Group 5: ATI-1777 topical solution 2.0% w/w (QD)
- Group 6: Vehicle (QD)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.