Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 6 Months and 11 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study design is parallel for children and a single group for infants.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
For subjects aged 2 to <12 years at screening, the trial is double-blind to ensure an objective evaluation of efficacy and safety of the Investigational Medicinal Product (IMP). The subject, the subject's caregiver(s), and the investigator involved in the clinical evaluation and monitoring of the subjects will not be aware of the treatment from baseline to Week 16. However, the site staff that responsible for administering tralokinumab will be aware of the treatment allocation as tralokinumab is visibly different from placebo and has a higher viscosity, requiring more pressure to depress the plunger during injections.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tralokinumab + TCS for subjects aged 2 to <12 years 		Dose and dosing frequency for each subject will depend on the subject's body weight.
  • Drug: Tralokinumab + TCS
    The trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
Experimental
Placebo + TCS for subjects aged 2 to <12 years 		Dose and dosing frequency for each subject will depend on the subject's body weight.
  • Drug: Placebo + TCS
    The trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
Experimental
Tralokinumab + TCS for subjects aged 6 months to <2 years 		Dose and dosing frequency for each subject will depend on the subject's body weight.
  • Drug: Tralokinumab + TCS
    The trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.

Recruiting Locations

Leo Pharma Investigational site
Birmingham, Alabama 35209

Leo Pharma Investigational site
North Little Rock, Arkansas 72117

Leo Pharma Investigational site
Palo Alto, California 94304

Leo Pharma Investigational site
Sacramento, California 95816

Leo Pharma Investigational site
San Diego, California 92123

Leo Pharma Investigational site
Jacksonville, Florida 32256

Leo Pharma Investigational site
Miami, Florida 33156

Leo Pharma Investigational site
Tampa, Florida 33613

Leo Pharma Investigational site
Macon, Georgia 31217

Leo Pharma Investigational site
Waterford, Michigan 48328

Leo Pharma Investigational site
Tulsa, Oklahoma 74136

Leo Pharma Investigational site
Portland, Oregon 97239

Leo Pharma Investigational site
Charleston, South Carolina 27420

Leo Pharma Investigational site
Norfolk, Virginia 23502

More Details

Status
Recruiting
Sponsor
LEO Pharma

Study Contact

Clinical Disclosure
+45 4494 5888
disclosure@leo-pharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.