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

Atopic Dermatitis Clinical Trial

— ADHAND  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Eczema

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