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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05958407
Other study ID # LP0162-2328
Secondary ID U1111-1285-70142
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 28, 2023
Est. completion date March 22, 2027

Study information

Verified date June 2024
Source LEO Pharma
Contact Clinical Disclosure
Phone (+1) 8775571168
Email disclosure@leo-pharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 402
Est. completion date March 22, 2027
Est. primary completion date November 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Belgium LEO Pharma Investigational site Bruxelles
Belgium LEO Pharma Investigational site Edegem
Canada 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 Fredericton New Brunswick
Canada LEO Pharma Investigational Site Hamilton Ontario
Canada LEO Pharma Investigational Site Kingston Ontario
Canada LEO Pharma Investigational Site Laval Quebec
Canada LEO Pharma Investigational Site Quebec
Canada LEO Pharma Investigational Site Quebec
Canada LEO Pharma Investigational Site Red Deer Alberta
Canada LEO Pharma Investigational Site Richmond Hill Ontario
Canada LEO Pharma Investigational Site Saint-Jérôme Quebec
Canada LEO Pharma Investigational Site Surrey British Columbia
Canada LEO Pharma Investigational Site Toronto Ontario
Canada LEO Pharma Investigational Site Windsor Ontario
Korea, Republic of LEO Pharma Investigational Site Ansan-si Gyeonggi-do
Korea, Republic of LEO Pharma Investigational Site Daegu
Korea, Republic of LEO Pharma Investigational Site Daejeon
Korea, Republic of LEO Pharma Investigational Site Seoul
Korea, Republic of LEO Pharma Investigational Site Seoul
Korea, Republic of LEO Pharma Investigational Site Seoul
Korea, Republic of LEO Pharma Investigational Site Seoul
Korea, Republic of LEO Pharma Investigational Site Seoul
Korea, Republic of LEO Pharma Investigational Site Wonju Gangwon-do
Korea, Republic of LEO Pharma Investigational Site Yangsan Gyeongsangnam-do
Netherlands LEO Pharma Investigational Site Amsterdam
Netherlands LEO Pharma Investigational Site Groningen
United Kingdom LEO Pharma Investigational Site Bath Avon
United Kingdom LEO Pharma Investigational Site Dudley West Midlands
United Kingdom LEO Pharma Investigational Site Middlesborough North Yorkshire
United Kingdom LEO Pharma Investigational Site Salford Greater Manchester
United States LEO Pharma Investigational Site Bangor Maine
United States LEO Pharma Investigational Site Birmingham Alabama
United States LEO Pharma Investigational Site Caledonia Michigan
United States LEO Pharma Investigational Site Cortland New York
United States LEO Pharma Investigational Site Dallas Texas
United States LEO Pharma Investigational Site Farmington Connecticut
United States LEO Pharma Investigational Site Fort Smith Arkansas
United States LEO Pharma Investigational Site Fountain Valley California
United States LEO Pharma Investigational Site Frisco Texas
United States LEO Pharma Investigational Site Hialeah Florida
United States LEO Pharma Investigational Site Los Angeles California
United States LEO Pharma Investigational Site Louisville Kentucky
United States LEO Pharma Investigational Site Nashville Tennessee
United States LEO Pharma Investigational Site New Orleans Louisiana
United States LEO Pharma Investigational Site New York New York
United States LEO Pharma Investigational Site North Charleston South Carolina
United States LEO Pharma Investigational Site Plainfield Indiana
United States LEO Pharma Investigational Site Portland Oregon
United States LEO Pharma Investigational Site Portland Oregon
United States LEO Pharma Investigational Site Portsmouth New Hampshire
United States LEO Pharma Investigational Site Sacramento California
United States LEO Pharma Investigational Site San Antonio Texas
United States LEO Pharma Investigational Site Tampa Florida
United States LEO Pharma Investigational Site Toledo Ohio
United States LEO Pharma Investigational Site Webster Texas

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Korea, Republic of,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Having a decrease in HECSI of at least 75% (HECSI-75) HECSI: The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs using a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and the extent of the lesions on each of the 5 hand areas by assessing the percentage of the areas these lesions occupy and converting it to a score based on a 5-point scale. From baseline (Day 1) to Week 16
Secondary Having a decrease in HECSI of at least 50% (HECSI-50) From baseline to Week 16
Secondary Having a decrease in HECSI of at least 90% (HECSI-90) From baseline to Week 16
Secondary Percentage change in HECSI score From baseline to Week 16
Secondary Having a =2-point reduction in IGA-AHE score From baseline to Week 16
Secondary Reduction in HESD itch score (weekly average) of =4 points HESD: The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)'. Only the items on itch and pain will be completed. From baseline to Week 16
Secondary Reduction in HESD pain score (weekly average) of =4 points Among subjects with a baseline HESD pain score (weekly average) =4 points. From baseline to Week 16
Secondary Percentage change in HEIS score HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the subject's perception of the impact of hand eczema on their daily activities over the past 7 days. Each item is scored on a 5-point scale (0='not at all', 1='a little', 2='moderately', 3='a lot', 4='extremely'). From baseline to Week 16
Secondary Percentage change in DLQI score DLQI: The Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life over the last week. Each item is scored on a 4-point Likert scale (0 = 'not at all /not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). From baseline to Week 16
Secondary Percentage change in HESD itch score (weekly average) From baseline to Week 16
Secondary Percentage change in HESD pain score (weekly average) From baseline to Week 16
Secondary Change in WPAI+CIQ:AHE domain scores WPAI+CIQ:AHE: The impact of AHE on the subject's ability to work/school and perform regular activities will be assessed by WPAI+CIQ:AHE, which is an instrument to measure impairments in both paid work and unpaid work/school attendance. The WPAI+CIQ:AHE consists of 10 items, and scores can be calculated for 7 domains, each reflecting the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance. From baseline to Week 16
Secondary Number of treatment-emergent adverse events From baseline to Week 16
Secondary IGA-AHE score of 0 (clear) or 1 (almost clear) At Week 32
Secondary Having a decrease in HECSI of at least 75% (HECSI-75) From baseline to Week 32
Secondary Reduction in HESD itch score (weekly average) of =4 points From baseline to Week 32
Secondary Reduction in HESD pain score (weekly average) of =4 points Among subjects with a baseline HESD pain score (weekly average) =4 points From baseline to Week 32
Secondary Percentage change in HEIS score From baseline to Week 32
Secondary Percentage change in DLQI score From baseline to Week 32
Secondary Change in WPAI+CIQ:AHE domain scores From baseline to Week 32
Secondary Number of treatment-emergent adverse events during the open-label treatment period Week 16 to Week 32
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