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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
Awards & highlights
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
Change from baseline in vIGA score at each post-baseline study visit
+4 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 2.0% w/w
2022
Completed Phase 2
~250
ATI-1777 1.0% 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
33 Previous Clinical Trials
4,641 Total Patients Enrolled
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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.
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