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

NCT05958407 | Completed Phase 3 FDA Drug

• 3 other identifiers: LP0162-2328U1111-1285-70142022-502653-34-00
• Study Type: interventional
• Target: 235
• Locations: 10 countries
• Sites: 69

Brief Summary

The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat 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. There will be up to 15 visits, 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 are off the drug for safety follow-up.

Conditions

Atopic Dermatitis; Atopic Hand Eczema

Outcome Measures

Primary Outcomes (1)

• IGA-AHE score of 0 (clear) or 1 (almost clear)

  IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  At Week 16

Secondary Outcomes (21)

• Having a decrease in HECSI of at least 75% (HECSI-75)

  From baseline (Day 1) to Week 16

• Having a decrease in HECSI of at least 50% (HECSI-50)

  From baseline to Week 16

• Having a decrease in HECSI of at least 90% (HECSI-90)

  From baseline to Week 16

• Percentage change in HECSI score

  From baseline to Week 16

• Having a ≥2-point reduction in IGA-AHE score

  From baseline to Week 16

Study Arms (2)

Tralokinumab

EXPERIMENTAL

Tralokinumab is administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period)

Drug: Tralokinumab

Placebo + tralokinumab

PLACEBO COMPARATOR

Placebo is administered for 16 weeks (double-blinded period) prior to roll-over to a 16 weeks open-label period where tralokinumab is administered

Drug: Placebo

Interventions

Tralokinumab DRUG

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

Tralokinumab

Placebo DRUG

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

Placebo + tralokinumab

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (69)

LEO Pharma Investigational Site

Birmingham, Alabama, 35209, United States

Location

LEO Pharma Investigational Site

Fort Smith, Arkansas, 72916, United States

Location

LEO Pharma Investigational Site

Fountain Valley, California, 92708, United States

Location

LEO Pharma Investigational Site

Los Angeles, California, 90025, United States

Location

LEO Pharma Investigational Site

Sacramento, California, 95816, United States

Location

LEO Pharma Investigational Site

Farmington, Connecticut, 06032, United States

Location

LEO Pharma Investigational Site

Hialeah, Florida, 33012, United States

Location

LEO Pharma Investigational Site

Plainfield, Indiana, 46168, United States

Location

LEO Pharma Investigational Site

Louisville, Kentucky, 40217, United States

Location

LEO Pharma Investigational Site

New Orleans, Louisiana, 70115, United States

Location

LEO Pharma Investigational Site

Bangor, Maine, 04401, United States

Location

LEO Pharma Investigational Site

Caledonia, Michigan, 49316, United States

Location

LEO Pharma Investigational Site

Detroit, Michigan, 48202, United States

Location

LEO Pharma Investigational Site

Portsmouth, New Hampshire, 03801, United States

Location

LEO Pharma Investigational Site

Cortland, New York, 13045, United States

Location

LEO Pharma Investigational Site

New York, New York, 10075, United States

Location

LEO Pharma Investigational Site

Portland, Oregon, 97201, United States

Location

LEO Pharma Investigational Site

Portland, Oregon, 97210, United States

Location

LEO Pharma Investigational Site

Nashville, Tennessee, 37211, United States

Location

LEO Pharma Investigational Site

Dallas, Texas, 75225, United States

Location

LEO Pharma Investigational Site

Frisco, Texas, 75034, United States

Location

LEO Pharma Investigational Site

San Antonio, Texas, 78213, United States

Location

LEO Pharma Investigational Site

Webster, Texas, 77598, United States

Location

LEO Pharma Investigational Site

Brussels, 1200, Belgium

Location

LEO Pharma Investigational Site

Edegem, 2650, Belgium

Location

LEO Pharma Investigational site

Ghent, 9000, Belgium

Location

LEO Pharma Investigational Site

Calgary, Alberta, T3E 0B2, Canada

Location

LEO Pharma Investigational Site

Edmonton, Alberta, T5J 3S9, Canada

Location

LEO Pharma Investigational Site

Edmonton, Alberta, T6X 0N9, Canada

Location

LEO Pharma Investigational Site

Red Deer, Alberta, T4P 1K4, Canada

Location

LEO Pharma Investigational Site

Surrey, British Columbia, V3R 6A7, Canada

Location

LEO Pharma Investigational Site

Fredericton, New Brunswick, E3B 1G9, Canada

Location

LEO Pharma Investigational Site

Hamilton, Ontario, L8L 3C3, Canada

Location

LEO Pharma Investigational Site

Richmond Hill, Ontario, L4B 1A5, Canada

Location

LEO Pharma Investigational Site

Toronto, Ontario, M2N 3A6, Canada

Location

LEO Pharma Investigational Site

Windsor, Ontario, N8T 1E6, Canada

Location

LEO Pharma Investigational Site

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

LEO Pharma Investigational Site

Québec, G1V 4X7, Canada

Location

LEO Pharma Investigational Site

Québec, G1W 4R4, Canada

Location

LEO Pharma Investigational Site

Nantes, 44093, France

Location

LEO Pharma Investigational Site

Pierre-Bénite, 69495, France

Location

LEO Pharma Investigational Site

Rouen, 76031, France

Location

LEO Investigational Site

Bretzenheim, 55128, Germany

Location

LEO Pharma Investigational Site

Frankfurt am Main, 60590, Germany

Location

LEO Pharma Investigational Site

Haßfurt, 97437, Germany

Location

LEO Pharma Investigational Site

Osnabrück, 49074, Germany

Location

LEO Pharma Investigational Site

Tübingen, 72076, Germany

Location

LEO Pharma Investigational Site

Wuppertal, 42283, Germany

Location

LEO Pharma Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

LEO Pharma Investigational Site

Groningen, 9713 GZ, Netherlands

Location

LEO Pharma Investigational Site

Gdansk, 80-462, Poland

Location

LEO Pharma Investigational Site

Krakow, 30-033, Poland

Location

LEO Pharma Investigational Site

Krakow, 31-011, Poland

Location

LEO Pharma Investigational Site

Wŏnju, Gangwon-do, 26426, South Korea

Location

LEO Pharma Investigational Site

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

LEO Pharma Investigational Site

Yangsan, Gyeongsangnam-do, 05278, South Korea

Location

LEO Pharma Investigational Site

Daegu, 41944, South Korea

Location

LEO Pharma Investigational Site

Seoul, 03080, South Korea

Location

LEO Pharma Investigational Site

Seoul, 04763, South Korea

Location

LEO Pharma Investigational Site

Seoul, 05030, South Korea

Location

LEO Pharma Investigational Site

Seoul, 05278, South Korea

Location

LEO Pharma Investigational Site

Seoul, 4564, South Korea

Location

LEO Pharma Investigational Site

Badalona, Barcelona, 08916, Spain

Location

LEO Pharma Investigational site

Alicante, 03010, Spain

Location

LEO Pharma Investigational site

Barcelona, 08916, Spain

Location

LEO Pharma Investigational site

Granada, 18016, Spain

Location

LEO Pharma Investigational Site

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

LEO Pharma Investigational Site

Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

Location

LEO Pharma Investigational Site

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tralokinumab

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

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 24, 2023
• Study Start: August 28, 2023
• Primary Completion: May 5, 2025
• Study Completion: September 22, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); FR (3); PL (3); GB (3); NL (2); US (23); CA (13); DE (6); KR (9); ES (4)