Clinical trial NCT05958407: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Atopic Hand Eczema
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: IGA-AHE score of 0 (clear) or 1 (almost clear)
timeFrame: At Week 16
Secondary outcomes:
measure: Having a decrease in HECSI of at least 75% (HECSI-75)
timeFrame: From baseline (Day 1) to Week 16
measure: Having a decrease in HECSI of at least 50% (HECSI-50)
timeFrame: From baseline to Week 16
measure: Having a decrease in HECSI of at least 90% (HECSI-90)
timeFrame: From baseline to Week 16
measure: Percentage change in HECSI score
timeFrame: From baseline to Week 16
measure: Having a ≥2-point reduction in IGA-AHE score
timeFrame: From baseline to Week 16
measure: Reduction in HESD itch score (weekly average) of ≥4 points
timeFrame: From baseline to Week 16
measure: Reduction in HESD pain score (weekly average) of ≥4 points
timeFrame: From baseline to Week 16
measure: Percentage change in HEIS score
timeFrame: From baseline to Week 16
measure: Percentage change in DLQI score
timeFrame: From baseline to Week 16
measure: Percentage change in HESD itch score (weekly average)
timeFrame: From baseline to Week 16
measure: Percentage change in HESD pain score (weekly average)
timeFrame: From baseline to Week 16
measure: Change in WPAI+CIQ:AHE domain scores
timeFrame: From baseline to Week 16
measure: Number of treatment-emergent adverse events
timeFrame: From baseline to Week 16
measure: IGA-AHE score of 0 (clear) or 1 (almost clear)
timeFrame: At Week 32
measure: Having a decrease in HECSI of at least 75% (HECSI-75)
timeFrame: From baseline to Week 32
measure: Reduction in HESD itch score (weekly average) of ≥4 points
timeFrame: From baseline to Week 32
measure: Reduction in HESD pain score (weekly average) of ≥4 points
timeFrame: From baseline to Week 32
measure: Percentage change in HEIS score
timeFrame: From baseline to Week 32
measure: Percentage change in DLQI score
timeFrame: From baseline to Week 32
measure: Change in WPAI+CIQ:AHE domain scores
timeFrame: From baseline to Week 32
measure: Number of treatment-emergent adverse events during the open-label treatment period
timeFrame: Week 16 to Week 32
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: LEO Pharma Investigational Site
state: Alabama
city: Fort Smith
country: United States
facility: LEO Pharma Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Los Angeles
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Sacramento
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Farmington
country: United States
facility: LEO Pharma Investigational Site
state: Connecticut
city: Hialeah
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Tampa
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Plainfield
country: United States
facility: LEO Pharma Investigational Site
state: Indiana
city: Louisville
country: United States
facility: LEO Pharma Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: LEO Pharma Investigational Site
state: Louisiana
city: Bangor
country: United States
facility: LEO Pharma Investigational Site
state: Maine
city: Caledonia
country: United States
facility: LEO Pharma Investigational Site
state: Michigan
city: Detroit
country: United States
facility: LEO Investigational Site
state: Michigan
city: Portsmouth
country: United States
facility: LEO Pharma Investigational Site
state: New Hampshire
city: Cortland
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: New York
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: Toledo
country: United States
facility: LEO Pharma Investigational Site
state: Ohio
city: Portland
country: United States
facility: LEO Pharma Investigational Site
state: Oregon
city: Portland
country: United States
facility: LEO Pharma Investigational Site
state: Oregon
city: North Charleston
country: United States
facility: LEO Pharma Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: LEO Pharma Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Frisco
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Webster
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Bruxelles
country: Belgium
facility: LEO Pharma Investigational Site
city: Bruxelles
country: Belgium
facility: LEO Pharma Investigational site
city: Edegem
country: Belgium
facility: LEO Pharma Investigational Site
city: Calgary
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: LEO Pharma Investigational Site
state: British Columbia
city: Fredericton
country: Canada
facility: LEO Pharma Investigational Site
state: New Brunswick
city: Hamilton
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Richmond Hill
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Laval
country: Canada
facility: LEO Pharma Investigational Site
state: Quebec
city: Saint-Jérôme
country: Canada
facility: LEO Pharma Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: LEO Pharma Investigational Site
city: Quebec
country: Canada
facility: LEO Pharma Investigational Site
city: Nantes
country: France
facility: LEO Pharma Investigational Site
city: Pierre-Bénite
country: France
facility: LEO Pharma Investigational Site
city: Frankfurt am Main
country: Germany
facility: LEO Pharma Investigational Site
city: Haßfurt
country: Germany
facility: LEO Pharma Investigational Site
city: Mainz-Bretzenheim
country: Germany
facility: LEO Investigational Site
city: Osnabrück
country: Germany
facility: LEO Pharma Investigational Site
city: Tübingen
country: Germany
facility: LEO Pharma Investigational Site
city: Wuppertal
country: Germany
facility: LEO Pharma Investigational Site
city: Wonju
country: Korea, Republic of
facility: LEO Pharma Investigational Site
state: Gangwon-do
city: Ansan-si
country: Korea, Republic of
facility: LEO Pharma Investigational Site
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: LEO Pharma Investigational Site
state: Gyeongsangnam-do
city: Daegu
country: Korea, Republic of
facility: LEO Pharma Investigational Site
city: Daejeon
country: Korea, Republic of
facility: LEO Pharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: LEO Pharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: LEO Pharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: LEO Pharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: LEO Pharma Investigational Site
city: Seoul
country: Korea, Republic of
facility: LEO Pharma Investigational Site
city: Amsterdam
country: Netherlands
facility: LEO Pharma Investigational Site
city: Groningen
country: Netherlands
facility: LEO Pharma Investigational Site
city: Rotterdam
country: Netherlands
facility: LEO Pharma Investigational Site
city: Gdansk
country: Poland
facility: LEO Pharma Investigational Site
city: Krakow
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Badalona
country: Spain
facility: LEO Investigational Site
state: Barcelona
city: Alicante
country: Spain
facility: LEO Pharma Investigational site
city: Barcelona
country: Spain
facility: LEO Investigational site
city: Granada
country: Spain
facility: LEO Pharma Investigational site
city: Salford
country: United Kingdom
facility: LEO Pharma Investigational Site
state: Greater Manchester
city: Middlesborough
country: United Kingdom
facility: LEO Pharma Investigational Site
state: North Yorkshire
city: Dudley
country: United Kingdom
facility: LEO Pharma Investigational Site
state: West Midlands
city: London
country: United Kingdom
facility: LEO Pharma Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: