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Monoclonal Antibodies

ATI-2138 for Eczema

Phase 2
Recruiting
Research Sponsored by Aclaris Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male patients or non-pregnant, non-nursing female patients 18 to 60 years old, inclusive, at the time of informed consent/assent
Be between 18 and 65 years old
Must not have
Any prior exposure to systemic (oral) JAK inhibitors or TYK inhibitors at any time prior to Screening
Female patients who are pregnant, nursing, or planning to become pregnant during the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called ATI-2138 in people with moderate to severe eczema.

Who is the study for?
This trial is for adults aged 18-60 with a history of moderate to severe atopic dermatitis (AD) or eczema for at least one year. Participants should not have had significant AD flares in the month before screening and must be able to understand and sign consent forms. Pregnant or nursing women, those planning pregnancy during the study, or anyone who has used certain systemic inhibitors are excluded.
What is being tested?
The study is testing ATI-2138, an investigational drug for treating moderate to severe atopic dermatitis. It's a Phase 2 trial where all participants receive ATI-2138 openly without being compared to another treatment or placebo.
What are the potential side effects?
While specific side effects of ATI-2138 aren't listed here, common side effects for treatments in AD may include skin irritation, infections due to immune system changes, headache, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old, not pregnant, and not nursing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never taken JAK or TYK inhibitors before.
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I am not pregnant, nursing, or planning to become pregnant during the study.
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My eczema often requires hospital visits or IV treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ATI-2138Experimental Treatment1 Intervention
ATI-2138 oral tablets BID

Find a Location

Who is running the clinical trial?

Aclaris Therapeutics, Inc.Lead Sponsor
34 Previous Clinical Trials
4,927 Total Patients Enrolled
Ajay Aggarwal, MDStudy DirectorAclaris Therapeutics, Inc.
2 Previous Clinical Trials
352 Total Patients Enrolled
~6 spots leftby Apr 2025
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