A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

The purpose of this trial is to test different doses of the trial medicine (LEO 138559) and see how well they work and how safe they are at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses. The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks. The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin. At each visit the doctor will check the participants atopic dermatitis and if they have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life. LEO 138559 is also called "Temtokibart".

Key facts

Study ID

NCT05923099

Run by

LEO Pharma

People needed

262

Starts

2023-09-20

Expected to finish

2025-04-09

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• LEO Investigational Site — Badalona, Barcelona, Spain
• LEO Investigational Site — Alcobendas, Spain
• LEO Investigational Site — Alicante, Spain
• LEO Investigational Site — Barcelona, Spain
• LEO Investigational Site — Córdoba, Spain
• LEO Investigational Site — Madrid, Spain
• LEO Investigational Site — Zaragoza, Spain
• LEO Investigational Site — Edinburgh, United Kingdom
• LEO Investigational Site — Harrow, United Kingdom
• LEO Investigational Site — London, United Kingdom
• LEO Investigational Site — Manchester, United Kingdom
• LEO Investigational Site — Southampton, United Kingdom
• LEO Investigational Site — Walsall, United Kingdom
• LEO Investigational Site — Malbork, Poland
• LEO Investigational Site — Mikołów, Poland
• LEO Investigational Site — Wroclaw, Poland
• LEO Investigational Site — Cluj-Napoca, Romania
• LEO Investigational Site — Iași, Romania
• LEO Investigational Site — Fountain Valley, California, United States
• LEO Investigational Site — Los Angeles, California, United States
• LEO Investigational Site — San Francisco, California, United States
• LEO Investigational Site — Hialeah, Florida, United States
• LEO investigational site — Indianapolis, Indiana, United States
• LEO investigational Site — New Albany, Indiana, United States
• LEO Investigational Site — Timișoara, Romania

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.