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NCT05958407

PHASE3

A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

Sponsor: LEO Pharma

View on ClinicalTrials.gov

Summary

The purpose of this study is to test if treatment with tralokinumab is safe and efficacious in treating moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life. The trial will last for up to 40 weeks for each participant. There will be up to 15 visits for each participant, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants will not receive tralokinumab but are monitored for safety.

Official title: A Phase 3b, Interventional, Adaptive, Clinical Trial to Evaluate the Efficacy and Safety of Tralokinumab 300 mg Every Second Week Monotherapy Compared With Placebo in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

235

Start Date

2023-08-28

Completion Date

2025-09-22

Last Updated

2026-08-05

Healthy Volunteers

Conditions

Atopic Dermatitis Atopic Hand Eczema

Interventions

DRUG

Tralokinumab

After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants are administered a dose of 300 mg every two weeks for 32 weeks

DRUG

Placebo

After a loading dose under the skin (s.c.) at baseline, trial participants are administered a placebo dose every two weeks for 16 weeks

Inclusion Criteria: * Age 18 years or above at screening * Diagnosis of atopic dermatitis (AD) as by the Hanifin and Rajka (1980) criteria for AD * History of AD for ≥1 year * Presence of atopic hand eczema (AHE) that has persisted for more than 3 months or returned twice or more within the last 12 months, with avoidance of any known and relevant irritants and allergens * AD involvement of at least one body location other than the hands and wrists at screening * An Investigator's Global Assessment AHE score of 3 or 4 (moderate to severe) at screening and baseline * A HESD itch score (weekly average) of ≥4 at baseline * Subjects who have a documented recent history (within 12 months before the screening visit) of inadequate response to treatment of AHE with topical prescription medications or for whom topical treatments are otherwise medically inadvisable (e.g., due to important side effects or safety risks) Exclusion Criteria: * Subjects must not enter the trial if they have active subtypes of hand eczema other than AHE that are considered to be the predominant cause of the current hand eczema including: * Active irritant contact dermatitis * Active allergic contact dermatitis * Active protein contact dermatitis/contact urticaria * Active hyperkeratotic hand eczema * Active vesicular hand eczema (pompholyx) * Active dermatologic conditions that may confound the diagnosis of AD or AHE, or that would interfere with the assessment of treatment * Use of tanning beds or phototherapy (e.g., UVB, UVA1, PUVA), or Grenz ray therapy on the hands or wrists within 28 days prior to baseline or use of bleach baths on the hands or wrists within 7 days prior to baseline * Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 28 days prior to baseline * Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical Janus kinase inhibitors within 7 days prior to baseline * Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to baseline

Locations (69)

LEO Pharma Investigational Site

Birmingham, Alabama, United States

LEO Pharma Investigational Site

Fort Smith, Arkansas, United States

LEO Pharma Investigational Site

Fountain Valley, California, United States

LEO Pharma Investigational Site

Los Angeles, California, United States

LEO Pharma Investigational Site

Sacramento, California, United States

LEO Pharma Investigational Site

Farmington, Connecticut, United States

LEO Pharma Investigational Site

Hialeah, Florida, United States

LEO Pharma Investigational Site

Plainfield, Indiana, United States

LEO Pharma Investigational Site

Louisville, Kentucky, United States

LEO Pharma Investigational Site

New Orleans, Louisiana, United States

LEO Pharma Investigational Site

Bangor, Maine, United States

LEO Pharma Investigational Site

Caledonia, Michigan, United States

LEO Pharma Investigational Site

Detroit, Michigan, United States

LEO Pharma Investigational Site

Portsmouth, New Hampshire, United States

LEO Pharma Investigational Site

Cortland, New York, United States

LEO Pharma Investigational Site

New York, New York, United States

LEO Pharma Investigational Site

Portland, Oregon, United States

LEO Pharma Investigational Site

Portland, Oregon, United States

LEO Pharma Investigational Site

Nashville, Tennessee, United States

LEO Pharma Investigational Site

Dallas, Texas, United States

LEO Pharma Investigational Site

Frisco, Texas, United States

LEO Pharma Investigational Site

San Antonio, Texas, United States

LEO Pharma Investigational Site

Webster, Texas, United States

LEO Pharma Investigational Site

Brussels, Belgium

LEO Pharma Investigational Site

Edegem, Belgium

LEO Pharma Investigational site

Ghent, Belgium

LEO Pharma Investigational Site

Calgary, Alberta, Canada

LEO Pharma Investigational Site

Edmonton, Alberta, Canada

LEO Pharma Investigational Site

Edmonton, Alberta, Canada

LEO Pharma Investigational Site

Red Deer, Alberta, Canada

LEO Pharma Investigational Site

Surrey, British Columbia, Canada

LEO Pharma Investigational Site

Fredericton, New Brunswick, Canada

LEO Pharma Investigational Site

Hamilton, Ontario, Canada

LEO Pharma Investigational Site

Richmond Hill, Ontario, Canada

LEO Pharma Investigational Site

Toronto, Ontario, Canada

LEO Pharma Investigational Site

Windsor, Ontario, Canada

LEO Pharma Investigational Site

Saint-Jérôme, Quebec, Canada

LEO Pharma Investigational Site

Québec, Canada

LEO Pharma Investigational Site

Québec, Canada

LEO Pharma Investigational Site

Nantes, France

LEO Pharma Investigational Site

Pierre-Bénite, France

LEO Pharma Investigational Site

Rouen, France

LEO Investigational Site

Bretzenheim, Germany

LEO Pharma Investigational Site

Frankfurt am Main, Germany

LEO Pharma Investigational Site

Haßfurt, Germany

LEO Pharma Investigational Site

Osnabrück, Germany

LEO Pharma Investigational Site

Tübingen, Germany

LEO Pharma Investigational Site

Wuppertal, Germany

LEO Pharma Investigational Site

Amsterdam, Netherlands

LEO Pharma Investigational Site

Groningen, Netherlands

LEO Pharma Investigational Site

Gdansk, Poland

LEO Pharma Investigational Site

Krakow, Poland

LEO Pharma Investigational Site

Krakow, Poland

LEO Pharma Investigational Site

Wŏnju, Gangwon-do, South Korea

LEO Pharma Investigational Site

Ansan-si, Gyeonggi-do, South Korea

LEO Pharma Investigational Site

Yangsan, Gyeongsangnam-do, South Korea

LEO Pharma Investigational Site

Daegu, South Korea

LEO Pharma Investigational Site

Seoul, South Korea

LEO Pharma Investigational Site

Seoul, South Korea

LEO Pharma Investigational Site

Seoul, South Korea

LEO Pharma Investigational Site

Seoul, South Korea

LEO Pharma Investigational Site

Seoul, South Korea

LEO Pharma Investigational Site

Badalona, Barcelona, Spain

LEO Pharma Investigational site

Alicante, Spain

LEO Pharma Investigational site

Barcelona, Spain

LEO Pharma Investigational site

Granada, Spain

LEO Pharma Investigational Site

Salford, Greater Manchester, United Kingdom

LEO Pharma Investigational Site

Middlesbrough, North Yorkshire, United Kingdom

LEO Pharma Investigational Site

London, United Kingdom

Clinical Research Directory

A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (69)