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New eczema drug shows promise in Mid-Stage trial

NCT ID NCT07011706

Disease control Sponsor: Aclaris Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether ATI-045 can safely reduce eczema symptoms like redness, itching, and skin patches in people with moderate-to-severe disease. About 110 adults who haven't had success with topical treatments will receive either the drug or a placebo. The main goal is to see how much their eczema improves after 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ATI-045
What this could lead to
If successful, this could point toward a new treatment option for people with moderate-to-severe eczema that doesn't respond well to topical creams.
What could go wrong
This is an early Phase 2 trial with only 110 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

110 people

The number who actually took part.

Started

May 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of chronic atopic dermatitis that has been present for ≥ 6 months before the screening visit and with no significant AD flares during the past 4 weeks before screening * Have active moderate to severe AD at screening and baseline visits * EASI score ≥ 16 and ≥10% BSA at the screening and baseline visits * History of inadequate response to treatment for AD with topical medications; or determination that topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks) * Patient applied a stable dose of non-medicated topical moisturizer (ideally once or twice daily) for ≥ 7 days prior to the baseline visit and agrees to continue use during study Exclusion Criteria: * Treatment with any of the following: 1. Intravenous immunoglobulin within 12 weeks prior to the baseline visit (W0D1) 2. Systemic antibiotics within 2 weeks prior to the baseline visit (W0D1) 3. Topical antibiotics within 1 week prior the baseline visit (W0D1) 4. Topical medicated treatment that could affect atopic dermatitis should be prohibited for at least 2 weeks prior to baseline visit. Example: topical corticosteroids, crisaborole, calcineurin inhibitors, ruxolitinib, roflumilast, tars, antimicrobials, medical devices, and bleach baths. 5. Topical products containing urea within 1 week prior to baseline visit (W0D1) 6. Doxepin, hydroxyzine, or diphenhydramine within 1 week prior to the baseline visit (W0D1) 7. Patient has used systemic treatments (other than biologics) that could affect AD less than 4 weeks or 5 half-lives (whichever is longer) prior to the baseline visit (W0D1), including, but not limited to, retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids, baricitinib, upadacitinib, and abrocitinib. 8. Biologics for AD treatments (such as dupilumab, tralokinumab, lebrikizumab, investigational biologics) within 5 half- lives or 12 weeks, whichever is longer prior to the baseline visit (W0D1) 9. An investigational drug (non-biologic) within 4 weeks or within 5 half-lives (if known), whichever is longer prior to the baseline visit (W0D1) 10. Phototherapy and photochemotherapy for AD within 4 weeks prior to the baseline visit (W0D1) 11. A live (attenuated) vaccine within 12 weeks prior to the baseline visit (W0D1) * History of anaphylaxis following biologic therapy. * History of allergy to corticosteroids, diphenhydramine, hydroxyzine, cetirizine, or fexofenadine.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease atopic eczema atopic IgE-mediated allergic disorder dermatitis Eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AD ATOPIC Atopic dermatitis Dermatitis Eczema

Contacts and locations

Locations

  • Aclaris Clinical Site

    Phoenix, Arizona, 85008, United States

  • Aclaris Clinical Site

    Tucson, Arizona, 85704, United States

  • Aclaris Clinical Site

    Beverly Hills, California, 90212, United States

  • Aclaris Clinical Site

    Encino, California, 91436, United States

  • Aclaris Clinical Site

    Huntington Beach, California, 92647, United States

  • Aclaris Clinical Site

    Sherman Oaks, California, 91403, United States

  • Aclaris Clinical Site

    Thousand Oaks, California, 91320, United States

  • Aclaris Clinical Site

    Hollywood, Florida, 33486, United States

  • Aclaris Clinical Site

    Jacksonville, Florida, 32256, United States

  • Aclaris Clinical Site

    Margate, Florida, 33063, United States

  • Aclaris Clinical Site

    Wellington, Florida, 33449, United States

  • Aclaris Clinical Site

    Atlanta, Georgia, 30315, United States

  • Aclaris Clinical Site

    Savannah, Georgia, 31405, United States

  • Aclaris Clinical Site

    Lafayette, Indiana, 47906, United States

  • Aclaris Clinical Site

    Ann Arbor, Michigan, 48103, United States

  • Aclaris Clinical Site

    Troy, Michigan, 48084, United States

  • Aclaris Clinical Site

    Ridgeland, Mississippi, 39157, United States

  • Aclaris Clinical Site

    Missoula, Montana, 59804, United States

  • Aclaris Clinical Site

    New York, New York, 10128, United States

  • Aclaris Clinical Site

    The Bronx, New York, 10455, United States

  • Aclaris Clinical Site

    Cary, North Carolina, 27518, United States

  • Aclaris Clinical Site

    Wilmington, North Carolina, 28405, United States

  • Aclaris Clinical Site

    Philadelphia, Pennsylvania, 19103, United States

  • Aclaris Clinical Site

    Myrtle Beach, South Carolina, 29588, United States

  • Aclaris Clinical Site

    Dallas, Texas, 75230, United States

  • Aclaris Clinical Site

    Houston, Texas, 77004, United States

  • Aclaris Clinical Site

    The Woodlands, Texas, 77380, United States

  • Aclaris Clinical Site

    Providence, Utah, 84332, United States

  • Aclaris Clinical Site

    Seattle, Washington, 98004, United States

  • Aclaris Clinical Site

    Spokane, Washington, 99202, United States

  • Aclaris Clinical Site

    Barrie, Ontario, L4M 7G1, Canada

  • Aclaris Clinical Site

    Toronto, Ontario, M2N 3A6, Canada

  • Aclaris Clinical Site

    Montreal, Quebec, H1Y3L1, Canada

  • Aclaris Site

    Markham, Ontario, L3P 1X3, Canada

  • Aclaris Site

    Mississauga, Ontario, L4Y 4C5, Canada

  • Aclaris Site

    Richmond Hill, Ontario, L4B 1A5, Canada

  • Aclaris Site

    Toronto, Ontario, M4W 2N2, Canada

  • Aclaris Study Site

    Bryant, Arkansas, 71913, United States

  • Aclaris Study Site

    Encinitas, California, 92024, United States

  • Aclaris Study Site

    Los Angeles, California, 90045, United States

  • Aclaris Study Site

    Oceanside, California, 92056, United States

  • Aclaris Study Site

    Santa Monica, California, 90404, United States

  • Aclaris Study Site

    Coral Gables, Florida, 33134, United States

  • Aclaris Study Site

    North Miami Beach, Florida, 33162, United States

  • Aclaris Study Site

    Sweetwater, Florida, 33172, United States

  • Aclaris Study Site

    Tampa, Florida, 33607, United States

  • Aclaris Study Site

    Boise, Idaho, 83706, United States

  • Aclaris Study Site

    Clarksville, Indiana, 47129, United States

  • Aclaris Study Site

    Indianapolis, Indiana, 46250, United States

  • Aclaris Study Site

    West Lafayette, Indiana, 47906, United States

  • Aclaris Study Site

    Bowling Green, Kentucky, 42104, United States

  • Aclaris Study Site

    Auburn Hills, Michigan, 48326, United States

  • Aclaris Study Site

    Saint Joseph, Missouri, 64506, United States

  • Aclaris Study Site

    New York, New York, 10023, United States

  • Aclaris Study Site

    New York, New York, 10075, United States

  • Aclaris Study Site

    Camp Hill, Pennsylvania, 17011, United States

  • Aclaris Study Site

    San Antonio, Texas, 78213, United States

  • Aclaris Study Site

    San Antonio, Texas, 78218, United States

  • Aclaris Study Site

    Webster, Texas, 77598, United States

  • Aclaris Study Site

    Norfolk, Virginia, 23502, United States

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