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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

A trial to evaluate the efficacy and safety of different doses of LEO 138559 in adults with moderate-to-severe atopic dermatitis.

262

Refer to the attached document.

This trial was conducted at 73 sites in 11 countries (Canada, Czech Republic, France, Germany, Hungary, Japan, Poland, Romania, Spain, United Kingdom, and United States). 262 participants were randomized 1:1:1:1:1 to 5 different treatment groups (4 different dose regimens of LEO 138559 and placebo).

Refer to the attached document.

Refer to the attached document.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230397

Kikuchi Aki

LEO Pharma K.K.

1-105 Kanda-Jinbocho, Chiyoda-ku, Tokyo

disclosure@leo-pharma.com

Clinical Disclosure

LEO Pharma

Industriparken 55 Ballerup Denmark

1-877-557-1168

disclosure@leo-pharma.com

Complete

Nov. 01, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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 greater than or equal to 1 year.
- Subjects who have a recent history (within 12 months before screening) with documented inadequate response to treatment with topical corticosteroid(s) (TCS) (+ or - 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 greater than or equal to 12 at screening and greater than or equal to 16 at baseline.
- validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score greater than or equal to 3 at screening and baseline.
- Body Surface Area (BSA) of AD involvement greater than or equal to 10% at screening and baseline.
- Atopic Dermatitis Symptom Diary (ADSD) Worst Itch score (weekly average) greater than or equal to 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

- 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
subjects 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 greater than or equal to 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 subjects 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 subjects 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

Both

Atopic Dermatitis

LEO 138559 or Placebo given by injection just under the skin

Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 16

Number of treatment-emergent adverse events (TEAEs) recorded for each subject from baseline to Week 16

+81-3-3881-6116

Aug. 18, 2023

Germany/Poland/Spain/France/Czech Republic/United Kingdom/Hungary/Romania/United States/Canada