A Phase 2 interventional study of ATI-2138 in Atopic Dermatitis, sponsored by Aclaris Therapeutics, Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Aclaris Therapeutics, Inc. · Phase 2, Interventional, and Treatment
This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.
This open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ATI-2138 administered over 12 weeks.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 14 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Aclaris Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ATI-2138 oral tablets BID
Drug: ATI-2138
ATI-2138 Oral Tablets BID
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: From baseline up to two weeks after treatment (Day 98)
Change from baseline Eczema Area and Severity Index (EASI) Over Time
Time frame: Up to Week 12
Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time
Time frame: Up to Week 12
Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time
Time frame: Up to Week 12
Change in IGA score over time
Time frame: Up to Week 12
Change from baseline in AD Body Surface Area (BSA) over time
Time frame: Up to week 12
Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time
Time frame: Up to Week 12
ATI-2138 trough concentration ng/mL
Time frame: Day 1 to Week 12
ATI-2138 peak concentration (Cmax) ng/mL
Time frame: Day 1 to Week 12
Ran from Aug 2024 to primary completion in Mar 2025, 6 months.
Of 195 industry-sponsored phase 2 interventional studies under Dermatitis, Atopic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 17. This study's 6 months is below that.
Counting every sponsor, half of 223 studies reached it within 14 months; a quarter within 10 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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