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

NCT05923099 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: LP0145-2240U1111-1286-09552022-500777-14-00
• Study Type: interventional
• Target: 262
• Locations: 11 countries
• Sites: 73

Brief Summary

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".

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percent Change in Eczema Area and Severity Index (EASI) Score

  The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe, and/or more extensive condition.

  From baseline to Week 16

Secondary Outcomes (1)

• Number of Treatment-emergent Adverse Events (TEAEs)

  From baseline (Week 0) to Week 16

Study Arms (5)

Dose regimen 1

EXPERIMENTAL

Dose A every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16

Drug: LEO 138559

Dose regimen 2

EXPERIMENTAL

Dose B every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16

Drug: LEO 138559

Dose regimen 3

EXPERIMENTAL

Dose A at Week 0 and Week 2, then dose C every 2 weeks from Week 4 to Week 16

Drug: LEO 138559

Dose regimen 4

EXPERIMENTAL

Dose C at Week 0 and Week 2, then dose D every 2 weeks from Week 4 to Week 16

Drug: LEO 138559

Placebo regimen

PLACEBO COMPARATOR

Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16

Drug: Placebo

Interventions

LEO 138559 DRUG

LEO 138559 given by injection just under the skin

Also known as: LEO 138559 is also called "temtokibart"

Dose regimen 1; Dose regimen 2; Dose regimen 3; Dose regimen 4

Placebo DRUG

Placebo given by injection just under the skin

Placebo regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent has been obtained prior to any protocol related procedures.
• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (73)

LEO Investigational Site

Fountain Valley, California, 92708, United States

Location

LEO Investigational Site

Los Angeles, California, 90045, United States

Location

LEO Investigational Site

San Francisco, California, 94115, United States

Location

LEO Investigational Site

Hialeah, Florida, 33012, United States

Location

LEO investigational site

Indianapolis, Indiana, 46250, United States

Location

LEO investigational Site

New Albany, Indiana, 47150, United States

Location

LEO Investigational Site

Ann Arbor, Michigan, 48103, United States

Location

LEO Investigational Site

New York, New York, 10029, United States

Location

LEO Investigational Site

Raleigh, North Carolina, 27609, United States

Location

LEO Investigational Site

Cincinnati, Ohio, 45219, United States

Location

LEO Investigational Site

Mayfield Heights, Ohio, 44124, United States

Location

LEO Investigational Site

North Charleston, South Carolina, 29420, United States

Location

LEO Investigational Site

Edmonton, Albana, T5J 3S9, Canada

Location

LEO Investigational Site

Calgary, Alberta, T2J 7E1, Canada

Location

LEO Investigational Site

Calgary, Alberta, T2W 4X9, Canada

Location

LEO Investigational Site

Edmonton, Alberta, T6G 1C3, Canada

Location

LEO Investigational Site

Surrey, British Columbia, V3R 6A7, Canada

Location

LEO Investigational Site

Mississauga, Ontario, L4Y 4C5, Canada

Location

LEO Investigational Site

Sherbrooke, Quebec, J1G 1X9, Canada

Location

LEO Investigational Site

Verdun, Quebec, H4G 3E7, Canada

Location

LEO Investigational Site

Náchod, 547 01, Czechia

Location

LEO Investigatonal Site

Ostrava-Poruba, 708 52, Czechia

Location

LEO Investigational Site

Prague, 100 34, Czechia

Location

LEO Investigational Site

Prague, 150 00, Czechia

Location

LEO Investigational Site

Martigues, Bouches-du-Rhône, 13500, France

Location

LEO Investigational Site

Dijon, 21000, France

Location

LEO Investigational Site

Nice, 06000, France

Location

LEO Investigational Site

Paris, 75010, France

Location

LEO Investigational Site

Rouen, 76031, France

Location

LEO Investigational Site

Augsburg, 86179, Germany

Location

LEO Investigational Site

Bad Bentheim, 48455, Germany

Location

LEO Investigational Site

Berlin, 10117, Germany

Location

LEO Investigational Site

Dresden, 01307, Germany

Location

LEO Investigational Site

Frankfurt am Main, 60590, Germany

Location

LEO Investigational Site

Freiburg im Breisgau, 79104, Germany

Location

LEO Investigational Site

Gera, 07548, Germany

Location

LEO Investigational Site

Kiel, 24105, Germany

Location

LEO Investigational Site

Leipzig, 04103, Germany

Location

LEO Investigational Site

Mahlow, 15831, Germany

Location

LEO Investigational Site

Münster, 48149, Germany

Location

LEO Investigational Site

Debrecen, 4032, Hungary

Location

LEO Investigational Site

Pécs, 7632, Hungary

Location

LEO Investigational Site

Szeged, 6720, Hungary

Location

LEO Investigational Site

Fukuoka, Fukuoka, 815-8588, Japan

Location

LEO Investigational Site

Kobe, Hyōgo, 657-0846, Japan

Location

LEO Investigational Site

Yokohama, Kanagawa, 220-6208, Japan

Location

LEO Investigational Site

Yokohama, Kanagawa, 231-0801, Japan

Location

LEO Investigational Site

Takatsuki-shi, Osaka, 569-0824, Japan

Location

LEO Investigational Site

Koto-ku, Tokyo, 136-0074, Japan

Location

LEO Investigational Site

Takaoka-shi, Toyama, 933-0871, Japan

Location

LEO Investigational Site

Tokyo, 167-0051, Japan

Location

LEO Investigational Site

Wroclaw, Lower Silesian Voivodeship, 50-450, Poland

Location

LEO Investigational Site

Krakow, 30-033, Poland

Location

LEO Investigational Site

Krakow, 31-011, Poland

Location

LEO Investigational Site

Malbork, 82-200, Poland

Location

LEO Investigational Site

Mikołów, 43-190, Poland

Location

LEO Investigational Site

Wroclaw, 50-224, Poland

Location

LEO Investigational Site

Cluj-Napoca, 400152, Romania

Location

LEO Investigational Site

Iași, 700291, Romania

Location

LEO Investigational Site

Timișoara, 300757, Romania

Location

LEO Investigational Site

Badalona, Barcelona, 08915, Spain

Location

LEO Investigational Site

Alcobendas, 5-28100, Spain

Location

LEO Investigational Site

Alicante, 03010, Spain

Location

LEO Investigational Site

Barcelona, 08907, Spain

Location

LEO Investigational Site

Córdoba, 14004, Spain

Location

LEO Investigational Site

Madrid, 28046, Spain

Location

LEO Investigational Site

Zaragoza, 50009, Spain

Location

LEO Investigational Site

Edinburgh, EH16 4SA, United Kingdom

Location

LEO Investigational Site

Harrow, HA1 3UJ, United Kingdom

Location

LEO Investigational Site

London, E1 1FR, United Kingdom

Location

LEO Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

LEO Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

LEO Investigational Site

Walsall, WS2 9PS, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Disclosure
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: September 20, 2023
• Primary Completion: December 11, 2024
• Study Completion: April 9, 2025
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (6); US (12); ES (7); DE (11); HU (3); JP (8); RO (3); FR (5); GB (6); CA (8); CZ (4)