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

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-site, Parallel-group, Dose-finding Trial to Evaluate the Efficacy and Safety of Different Doses of Subcutaneously Administered LEO 138559 in Adult Subjects With Moderate-to-severe Atopic Dermatitis

The purpose of this trial is to test different doses of the trial medicine (LEO 138559) 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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: LEO 138559; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Disclosure; Phone Number: (+1) 877-557-1168; Email: clinicaltrialscontactus@leo-pharma.com

Study Locations

• Canada
  • Albana
    • Edmonton, Albana, Canada, T5J 3S9
      • Recruiting
      • Leo Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Recruiting
      • Leo Investigational Site
    • Calgary, Alberta, Canada, T2W 4X9
      • Recruiting
      • Leo Investigational Site
    • Edmonton, Alberta, Canada, T6G 1C3
      • Recruiting
      • Leo Investigational Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Recruiting
      • Leo Investigational Site
  • Ontario
    • Mississauga, Ontario, Canada, L4Y 4C5
      • Recruiting
      • Leo Investigational Site
  • Quebec
    • Sherbrooke, Quebec, Canada, J1G 1X9
      • Recruiting
      • Leo Investigational Site
    • Verdun, Quebec, Canada, H4G 3E7
      • Recruiting
      • Leo Investigational Site
• Czechia
  • Náchod, Czechia, 547 01
    • Recruiting
    • Leo Investigational Site
  • Ostrava-Poruba, Czechia, 708 52
    • Recruiting
    • LEO Investigatonal Site
  • Prague, Czechia, 100 34
    • Recruiting
    • Leo Investigational Site
  • Praha 5, Czechia, 150 00
    • Recruiting
    • Leo Investigational Site
• France
  • Dijon, France, 21000
    • Recruiting
    • Leo Investigational Site
  • Nice, France, 06000
    • Recruiting
    • Leo Investigational Site
  • Paris, France, 75010
    • Recruiting
    • Leo Investigational Site
  • Rouen, France, 76031
    • Recruiting
    • Leo Investigational Site
  • Bouches-du-Rhône
    • Martigues, Bouches-du-Rhône, France, 13500
      • Recruiting
      • Leo Investigational Site
• Germany
  • Augsburg, Germany, 86179
    • Recruiting
    • Leo Investigational Site
  • Bad Bentheim, Germany, 48455
    • Recruiting
    • Leo Investigational Site
  • Berlin, Germany, 10117
    • Recruiting
    • Leo Investigational Site
  • Dresden, Germany, 01307
    • Recruiting
    • Leo Investigational Site
  • Frankfurt am Main, Germany, 60590
    • Recruiting
    • Leo Investigational Site
  • Freiburg, Germany, 79104
    • Recruiting
    • Leo Investigational Site
  • Gera, Germany, 07548
    • Recruiting
    • Leo Investigational Site
  • Kiel, Germany, 24105
    • Recruiting
    • Leo Investigational Site
  • Mahlow, Germany, 15831
    • Recruiting
    • Leo Investigational Site
  • Muenster, Germany, 48149
    • Recruiting
    • Leo Investigational Site
• Hungary
  • Pécs, Hungary, 7632
    • Recruiting
    • Leo Investigational Site
  • Szeged, Hungary, 6720
    • Recruiting
    • Leo Investigational Site
• Japan
  • Tokyo, Japan, 167-0051
    • Recruiting
    • Leo Investigational Site
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 815-8588
      • Recruiting
      • Leo Investigational Site
  • Hyogo
    • Kobe, Hyogo, Japan, 657-0846
      • Recruiting
      • Leo Investigational Site
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 231-0801
      • Recruiting
      • Leo Investigational Site
    • Yokohama-shi, Kanagawa, Japan, 220-6208
      • Recruiting
      • Leo Investigational Site
  • Osaka
    • Takatsuki-shi, Osaka, Japan, 569-0824
      • Recruiting
      • Leo Investigational Site
  • Tokyo
    • Koto-ku, Tokyo, Japan, 136-0074
      • Recruiting
      • Leo Investigational Site
  • Toyama
    • Takaoka-shi, Toyama, Japan, 933-0871
      • Recruiting
      • Leo Investigational Site
• Poland
  • Krakow, Poland, 30-033
    • Recruiting
    • Leo Investigational Site
  • Kraków, Poland, 31-011
    • Recruiting
    • Leo Investigational Site
  • Malbork, Poland, 82-200
    • Recruiting
    • Leo Investigational Site
  • Mikolow, Poland, 43-190
    • Recruiting
    • Leo Investigational Site
  • Wroclaw, Poland, 50-224
    • Recruiting
    • Leo Investigational Site
  • Dolnoslaskie
    • Wrocław, Dolnoslaskie, Poland, 50-450
      • Recruiting
      • Leo Investigational Site
• Romania
  • Cluj-Napoca, Romania, 400152
    • Recruiting
    • Leo Investigational Site
  • Iași, Romania, 700291
    • Recruiting
    • Leo Investigational Site
  • Timişoara, Romania, 300757
    • Recruiting
    • Leo Investigational Site
• Spain
  • Alcobendas, Spain, 5-28100
    • Recruiting
    • Leo Investigational Site
  • Alicante, Spain, 03010
    • Recruiting
    • Leo Investigational Site
  • Barcelona, Spain, 08907
    • Recruiting
    • Leo Investigational Site
  • Cordoba, Spain, 14004
    • Recruiting
    • Leo Investigational Site
  • Madrid, Spain, 28046
    • Recruiting
    • Leo Investigational Site
  • Zaragoza, Spain, 50009
    • Recruiting
    • Leo Investigational Site
  • Barcelona
    • Badalona, Barcelona, Spain, 08915
      • Recruiting
      • Leo Investigational Site
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Recruiting
    • Leo Investigational Site
  • London, United Kingdom, E1 1FR
    • Recruiting
    • Leo Investigational Site
  • Manchester, United Kingdom, M23 9QZ
    • Recruiting
    • Leo Investigational Site
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • Leo Investigational Site
  • Walsall, United Kingdom, WS2 9PS
    • Recruiting
    • Leo Investigational Site
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Recruiting
      • Leo Investigational Site
    • Los Angeles, California, United States, 90045
      • Recruiting
      • Leo Investigational Site
    • San Francisco, California, United States, 94115
      • Recruiting
      • Leo Investigational Site
  • Florida
    • Hialeah, Florida, United States, 33012
      • Recruiting
      • Leo Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Leo Investigational Site
    • New Albany, Indiana, United States, 47150
      • Recruiting
      • Leo Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Recruiting
      • Leo Investigational Site
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Leo Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Recruiting
      • Leo Investigational Site
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Recruiting
      • Leo Investigational Site
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • Recruiting
      • Leo Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose regimen 1; Dose A every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16	Drug: LEO 138559; LEO 138559 given by injection just under the skin
Experimental: Dose regimen 2; Dose B every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16	Drug: LEO 138559; LEO 138559 given by injection just under the skin
Experimental: Dose regimen 3; Dose A every week from Week 0 to Week 3, then dose C every 2 weeks from Week 4 to Week 16	Drug: LEO 138559; LEO 138559 given by injection just under the skin
Experimental: Dose regimen 4; Dose C every week from Week 0 to Week 3, then dose D every 2 weeks from Week 4 to Week 16	Drug: LEO 138559; LEO 138559 given by injection just under the skin
Placebo Comparator: Placebo regimen; Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16	Drug: Placebo; Placebo given by injection just under the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of treatment-emergent adverse events (TEAEs) recorded for each subject	From baseline (Week 0) to Week 16

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): December 9, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: LP0145-2240; U1111-1286-0955 (Other Identifier: World Health Organization (WHO)); 2022-500777-14-00 (Other Identifier: European Medicines Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No