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New eczema drug shows promise in Mid-Stage trial

NCT ID NCT05923099

Disease control Sponsor: LEO Pharma 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new medicine called LEO 138559 (Temtokibart) in 262 adults with moderate-to-severe atopic dermatitis (eczema). Participants received one of four doses or a placebo as injections under the skin for 16 weeks. The goal was to see how well the drug reduces eczema severity and if it is safe. Results will help determine the best dose for future studies.

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

262 people

The number who actually took part.

Started

Sep 2023

Finished

Apr 2025

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 75 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: * Signed and dated informed consent has been obtained prior to any protocol related procedures. * 18-75 years old (both included) at screening (Visit 1). * Willingness to comply with the clinical trial protocol. * At screening, diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria for AD. * History of AD for ≥1 year. * Subjects who have a recent history (within 12 months before screening) with documented inadequate response to treatment with topical corticosteroid(s) (TCS) (±topical calcineurin inhibitor(s) (TCI) as appropriate) or for whom these topical AD treatments are medically inadvisable (e.g. due to important side effects or safety risks). * Eczema Area and Severity Index (EASI) score ≥12 at screening and ≥16 at baseline. * Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at screening and baseline. * Body Surface Area (BSA) of AD involvement ≥10% at screening and baseline. * Atopic Dermatitis Symptom Diary (ADSD) Worst Itch score (weekly average) ≥4 at baseline. * A woman of childbearing potential must use a highly effective form of birth control throughout the trial and for at least 18 weeks after last administration of IMP. Exclusion Criteria: * Major surgery within 8 weeks prior to screening, or planned inpatient surgery or hospitalization during the trial period. * Active dermatologic condition that could confound the diagnosis of AD or interfere with assessment of the treatment (e.g. scabies, contact dermatitis, rosacea, urticaria, or psoriasis). * History of cancer, with the following exceptions: * Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to screening. * Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to screening * History of or current immunodeficiency syndrome. * History of anaphylaxis following any biologic therapy. * History of clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial. * Skin infection within 7 days prior to baseline * Positive HBsAg or positive anti-HCV AND positive HCV RNA at screening. * History of HIV infection or positive HIV serology at screening. * Evidence of active or latent tuberculosis according to local standard of care for patients requiring initiation of a biologic treatment. * ALT or AST level ≥2.0 times the ULN at screening. * History of attempted suicide or is at significant risk of suicide (either in the opinion of the investigator or defined as a "yes" to suicidal ideation questions no. 4 or 5 or answering "yes" to suicidal behavior on the C-SSRS Screening version). * Known or suspected hypersensitivity to any component(s) of the IMP. * Any disorder at screening and/or baseline, which is not stable in the opinion of the investigator, and could: * Affect the safety of the subject throughout the trial. * Influence the results of the trial. * Impede the subject's ability to complete the trial. * Any significant abnormal finding at screening and/or baseline which may, in the opinion of the investigator: * Put the subject at risk because of their participation in the trial. * Influence the results of the trial. * Influence the subject's ability to complete the trial. * Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator. * Women who are pregnant or breastfeeding. * Previous treatment with LEO 138559. * Previous exposure to fezakinumab (anti-IL-22 Ab). * Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, corticosteroids (steroid eyedrops and inhaled or intranasal steroids are allowed), or JAK inhibitors within 28 days or 5 half-lives prior to baseline, whichever is longer. * Use of tanning beds or phototherapy, within 4 weeks prior to baseline. * Receipt of blood products within 28 days prior to screening. * Treatment with: * Any marketed or investigational biologic agents within 3 months or 5 half-lives, whichever is longer, prior to baseline. * Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. * Treatment with TCS, TCI, topical PDE-4 inhibitors, topical JAK inhibitors, or other medicated topical treatments within 7 days prior to baseline. * Receipt of live attenuated vaccines 30 days prior to baseline. * Treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half lives prior to randomization, whichever is longer. * Current participation in any other interventional clinical trial. * Previously randomized in this clinical trial. * Employees of the trial site, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals. * Subjects who are legally institutionalized.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

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

Atopic dermatitis

Contacts and locations

Locations

  • LEO Investigational Site

    Fountain Valley, California, 92708, United States

  • LEO Investigational Site

    Los Angeles, California, 90045, United States

  • LEO Investigational Site

    San Francisco, California, 94115, United States

  • LEO Investigational Site

    Hialeah, Florida, 33012, United States

  • LEO Investigational Site

    Ann Arbor, Michigan, 48103, United States

  • LEO Investigational Site

    New York, New York, 10029, United States

  • LEO Investigational Site

    Raleigh, North Carolina, 27609, United States

  • LEO Investigational Site

    Cincinnati, Ohio, 45219, United States

  • LEO Investigational Site

    Mayfield Heights, Ohio, 44124, United States

  • LEO Investigational Site

    North Charleston, South Carolina, 29420, United States

  • LEO Investigational Site

    Edmonton, Albana, T5J 3S9, Canada

  • LEO Investigational Site

    Calgary, Alberta, T2J 7E1, Canada

  • LEO Investigational Site

    Calgary, Alberta, T2W 4X9, Canada

  • LEO Investigational Site

    Edmonton, Alberta, T6G 1C3, Canada

  • LEO Investigational Site

    Surrey, British Columbia, V3R 6A7, Canada

  • LEO Investigational Site

    Mississauga, Ontario, L4Y 4C5, Canada

  • LEO Investigational Site

    Sherbrooke, Quebec, J1G 1X9, Canada

  • LEO Investigational Site

    Verdun, Quebec, H4G 3E7, Canada

  • LEO Investigational Site

    Náchod, 547 01, Czechia

  • LEO Investigational Site

    Prague, 100 34, Czechia

  • LEO Investigational Site

    Prague, 150 00, Czechia

  • LEO Investigational Site

    Martigues, Bouches-du-Rhône, 13500, France

  • LEO Investigational Site

    Dijon, 21000, France

  • LEO Investigational Site

    Nice, 06000, France

  • LEO Investigational Site

    Paris, 75010, France

  • LEO Investigational Site

    Rouen, 76031, France

  • LEO Investigational Site

    Augsburg, 86179, Germany

  • LEO Investigational Site

    Bad Bentheim, 48455, Germany

  • LEO Investigational Site

    Berlin, 10117, Germany

  • LEO Investigational Site

    Dresden, 01307, Germany

  • LEO Investigational Site

    Frankfurt am Main, 60590, Germany

  • LEO Investigational Site

    Freiburg im Breisgau, 79104, Germany

  • LEO Investigational Site

    Gera, 07548, Germany

  • LEO Investigational Site

    Kiel, 24105, Germany

  • LEO Investigational Site

    Leipzig, 04103, Germany

  • LEO Investigational Site

    Mahlow, 15831, Germany

  • LEO Investigational Site

    Münster, 48149, Germany

  • LEO Investigational Site

    Debrecen, 4032, Hungary

  • LEO Investigational Site

    Pécs, 7632, Hungary

  • LEO Investigational Site

    Szeged, 6720, Hungary

  • LEO Investigational Site

    Fukuoka, Fukuoka, 815-8588, Japan

  • LEO Investigational Site

    Kobe, Hyōgo, 657-0846, Japan

  • LEO Investigational Site

    Yokohama, Kanagawa, 220-6208, Japan

  • LEO Investigational Site

    Yokohama, Kanagawa, 231-0801, Japan

  • LEO Investigational Site

    Takatsuki-shi, Osaka, 569-0824, Japan

  • LEO Investigational Site

    Koto-ku, Tokyo, 136-0074, Japan

  • LEO Investigational Site

    Takaoka-shi, Toyama, 933-0871, Japan

  • LEO Investigational Site

    Tokyo, 167-0051, Japan

  • LEO Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 50-450, Poland

  • LEO Investigational Site

    Krakow, 30-033, Poland

  • LEO Investigational Site

    Krakow, 31-011, Poland

  • LEO Investigational Site

    Malbork, 82-200, Poland

  • LEO Investigational Site

    Mikołów, 43-190, Poland

  • LEO Investigational Site

    Wroclaw, 50-224, Poland

  • LEO Investigational Site

    Cluj-Napoca, 400152, Romania

  • LEO Investigational Site

    Iași, 700291, Romania

  • LEO Investigational Site

    Timișoara, 300757, Romania

  • LEO Investigational Site

    Badalona, Barcelona, 08915, Spain

  • LEO Investigational Site

    Alcobendas, 5-28100, Spain

  • LEO Investigational Site

    Alicante, 03010, Spain

  • LEO Investigational Site

    Barcelona, 08907, Spain

  • LEO Investigational Site

    Córdoba, 14004, Spain

  • LEO Investigational Site

    Madrid, 28046, Spain

  • LEO Investigational Site

    Zaragoza, 50009, Spain

  • LEO Investigational Site

    Edinburgh, EH16 4SA, United Kingdom

  • LEO Investigational Site

    Harrow, HA1 3UJ, United Kingdom

  • LEO Investigational Site

    London, E1 1FR, United Kingdom

  • LEO Investigational Site

    Manchester, M23 9QZ, United Kingdom

  • LEO Investigational Site

    Southampton, SO16 6YD, United Kingdom

  • LEO Investigational Site

    Walsall, WS2 9PS, United Kingdom

  • LEO Investigatonal Site

    Ostrava-Poruba, 708 52, Czechia

  • LEO investigational Site

    New Albany, Indiana, 47150, United States

  • LEO investigational site

    Indianapolis, Indiana, 46250, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.