Clinical trial NCT06311682: A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis
Official title: A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 195
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is parallel for children and a single group for infants.
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.

The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.

The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.


Eligibility criteria: Inclusion Criteria:

* Age 6 months to \<12 years at screening.
* Body weight ≥9 kg at screening.
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
* History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 months for subjects aged 6 months to \<6 years at screening.
* Documented inadequate response to mid-strength TCS within 6 months before the screening visit.
* AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD.
* An EASI score of ≥16 at screening and baseline.
* An IGA score of ≥3 at screening and baseline.
* A Child Worst Itch NRS average score of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score of ≥4 (subjects aged \<6 years at screening) during the week prior to baseline.

Exclusion Criteria:

* Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinase inhibitors (JAK) within 1 week prior to baseline.
* Treatment with bleach baths within 1 week prior to baseline.
* Treatment with the immunomodulatory medications systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors) and systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery) within 4 weeks prior to baseline.
* Use of tanning beds or phototherapy within 4 weeks prior to baseline.
* Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit.
* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis.
* Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks before the baseline visit.
* History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.

Primary outcomes:
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
timeFrame: At week 16
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 16
Secondary outcomes:
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 16
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 16
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
timeFrame: At week 16
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 16
measure: Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening.
timeFrame: At week 16
measure: Having at least 50% reduction in EASI score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 16
measure: Percent change in EASI in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in EASI in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in affected BSA in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in affected BSA in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
timeFrame: From baseline to Week 16
measure: Reduction in Child Worst Itch numeric rating score (NRS) (weekly average) ≥4 for subjects aged 6 to <12 years at screening.
timeFrame: From baseline to Week 16
measure: Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 2 to <6 years at screening.
timeFrame: From baseline to week 16
measure: Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 6 months to <2 years years at screening.
timeFrame: From baseline to week 16
measure: Reduction of ≥4 in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening or Scratch ObsRO (weekly average) for subjects aged 2 to <6 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Change in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 2 to <6 years at screening.
timeFrame: From baseline to week 16
measure: Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Rescue treatment use (yes/no) in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Rescue treatment use (yes/no) in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Number of TCS free days in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 16
measure: Number of TCS free days in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 16
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
timeFrame: At week 52
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
timeFrame: At week 52
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 52
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 52
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 52
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 52
measure: Percent change in EASI in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 52
measure: Percent change in EASI in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 52
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 52
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 52
measure: Percent change in affected body surface area (BSA) in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 52
measure: Percent change in affected body surface area (BSA) in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 52
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 52
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 52
measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) in subjects aged 4 to <12 years at screening.
timeFrame: From baseline to week 52
measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening.
timeFrame: From baseline to week 52
measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 52
measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 52
measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.
timeFrame: From week 16 to 52
measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.
timeFrame: From week 16 to 52
measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening.
timeFrame: From week 16 to 52
measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening.
timeFrame: From week 16 to 52
measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.
timeFrame: From week 52 to end of treatment
measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.
timeFrame: From week 52 to end of treatment
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
timeFrame: At week 100
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
timeFrame: At week 100
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 100
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 100
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 100
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 100
measure: Percent change in EASI in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 100
measure: Percent change in EASI in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 100
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 100
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 100
measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
timeFrame: From baseline to week 100
measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.
timeFrame: From baseline to week 100
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
timeFrame: At week 148
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
timeFrame: At week 148
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 148
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 148
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 148
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 148
measure: Percent change in EASI in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 148
measure: Percent change in EASI in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 148
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 148
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 148
measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
timeFrame: From baseline to week 148
measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.
timeFrame: From baseline to week 148
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
timeFrame: At week 196
measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
timeFrame: At week 196
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 196
measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 196
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
timeFrame: At week 196
measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
timeFrame: At week 196
measure: Percent change in EASI in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 196
measure: Percent change in EASI in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 196
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
timeFrame: From baseline to week 196
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
timeFrame: From baseline to week 196
measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
timeFrame: From baseline to week 196
measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.
timeFrame: From baseline to week 196
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Leo Pharma Investigational site
state: Alabama
city: North Little Rock
country: United States
facility: Leo Pharma Investigational site
state: Arkansas
city: Palo Alto
country: United States
facility: Leo Pharma Investigational site
state: California
city: Sacramento
country: United States
facility: Leo Pharma Investigational site
state: California
city: San Diego
country: United States
facility: Leo Pharma Investigational site
state: California
city: San Diego
country: United States
facility: Leo Pharma Investigational site
state: California
city: Tampa
country: United States
facility: Leo Pharma Investigational site
state: Florida
city: Macon
country: United States
facility: Leo Pharma Investigational site
state: Georgia
city: Waterford
country: United States
facility: Leo Pharma Investigational site
state: Michigan
city: Tulsa
country: United States
facility: Leo Pharma Investigational site
state: Oklahoma
city: Portland
country: United States
facility: Leo Pharma Investigational site
state: Oregon
city: Norfolk
country: United States
facility: Leo Pharma Investigational site
state: Virginia
city: Brussel
country: Belgium
facility: Leo Pharma Investigational site
city: Ghent
country: Belgium
facility: Leo Pharma Investigational site
city: Leuven
country: Belgium
facility: Leo Pharma Investigational site
city: Liège
country: Belgium
facility: Leo Pharma Investigational site
city: Burlington
country: Canada
facility: Leo Pharma Investigational site
city: Calgary
country: Canada
facility: Leo Pharma Investigational site
city: Calgary
country: Canada
facility: Leo Pharma Investigational site
city: Edmonton
country: Canada
facility: Leo Pharma Investigational site
city: Edmonton
country: Canada
facility: Leo Pharma Investigational site
city: Hamilton
country: Canada
facility: Leo Pharma Investigational site
city: Niagara Falls
country: Canada
facility: Leo Pharma Investigational site
city: Saskatoon
country: Canada
facility: Leo Pharma Investigational site
city: Windsor
country: Canada
facility: Leo Pharma Investigational site
city: Winnipeg
country: Canada
facility: Leo Pharma Investigational site
city: Rijeka
country: Croatia
facility: Leo Pharma Investigational site
city: Zagreb
country: Croatia
facility: Leo Pharma Investigational site
city: Buxtehude
country: Germany
facility: Leo Pharma 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: Crumlin
country: Ireland
facility: Leo Pharma Investigational site
city: Ancona
country: Italy
facility: Leo Pharma Investigational site
city: Brescia
country: Italy
facility: Leo Pharma Investigational site
city: Roma
country: Italy
facility: Leo Pharma Investigational site
city: Rom
country: Italy
facility: Leo Pharma Investigational site
city: Ansan-si
country: Korea, Republic of
facility: Leo Pharma Investigational site
city: Gwangju
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: Seoul
country: Korea, Republic of
facility: Leo Pharma Investigational site
city: Seoul
country: Korea, Republic of
facility: Leo Pharma Investigational site
city: Utrecht
country: Netherlands
facility: Leo Pharma Investigational site
city: Gdansk
country: Poland
facility: Leo Pharma Investigational site
city: Kraków
country: Poland
facility: Leo Pharma Investigational site
city: Ostrowiec Świętokrzyski
country: Poland
facility: Leo Pharma Investigational site
city: Rzeszów
country: Poland
facility: Leo Pharma Investigational site
city: Tarnow
country: Poland
facility: Leo Pharma Investigational site
city: Warszawa
country: Poland
facility: Leo Pharma Investigational site
city: Warszawa
country: Poland
facility: Leo Pharma Investigational site
city: Łódź
country: Poland
facility: Leo Pharma Investigational site
city: Brasov
country: Romania
facility: Leo Pharma Investigational site
city: Alicante
country: Spain
facility: Leo Pharma Investigational site
city: Madrid
country: Spain
facility: Leo Pharma Investigational site
city: Valencia
country: Spain
facility: Leo Pharma Investigational site
city: Lincoln
country: United Kingdom
facility: Leo Pharma Investigational site
city: London
country: United Kingdom
facility: Leo Pharma Investigational site
city: Sheffield
country: United Kingdom
facility: Leo Pharma Investigational site
city: Southampton
country: United Kingdom
facility: Leo Pharma Investigational site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: