A Phase 2 interventional study of ATI-045 and Placebo in Atopic Dermatitis, Atopic and Dermatitis, sponsored by Aclaris Therapeutics, Inc.. Active, not recruiting at 60 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Aclaris Therapeutics, Inc. · Phase 2, Interventional, and Treatment
This study evaluates ATI-045 versus placebo in patients with Moderate-to-Severe Atopic Dermatitis.
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ATI-045 in Patients with Moderate-to-Severe Atopic Dermatitis.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 110 is above 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:
Treatment with any of the following:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ATI-045 group
Drug: ATI-045
Placebo group
Drug: Placebo
ATI-045 group
Placebo group
Percent Change in Eczema Area and Severity Index (EASI)
Percent change from baseline in EASI score at Week 24
Time frame: Baseline to Week 24
Investigator Global Assessment (vIGA) treatment success (IGA-TS)
Proportion of patients with validated Investigator Global Assessment (vIGA) treatment success (IGA-TS)
Time frame: Baseline to Week 24
EASI reduction
Proportion of patients with EASI reduction of 75% (EASI75), 50% (EASI50), 90% (EASI90)
Time frame: Baseline to Week 24
Peak Pruritus Numerical Rating Scale (PP-NRS) score
Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score
Time frame: Baseline to Week 24
PP-NRS improvement
Proportion of patients with a 4-point improvement or greater from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS)
Time frame: Baseline to Week 24
Body Surface Area (BSA)
Change from baseline in BSA
Time frame: Baseline to Week 24
Incidence and severity of safety measurements
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) after first study drug dose on W0D1 until patient's last visit.
Time frame: From Baseline to Week 34
Anti-ATI-045 antidrug antibody (ADA)
ADA evaluation
Time frame: From Baseline to Week 34
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2025 to primary completion in Sep 2026, 15 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 15 months is above that.
Counting every sponsor, half of 223 studies reached it within 14 months; a quarter within 10 and three quarters within 19.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Aug 2026 → Sep 2026 and completion Oct 2026 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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