Status:
RECRUITING
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
Lead Sponsor:
LEO Pharma
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
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 ...
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.
Key Trial Info
Start Date :
June 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2028
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT06311682
Start Date
June 10 2024
End Date
April 28 2028
Last Update
March 20 2026
Active Locations (72)
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1
Leo Pharma Investigational site
Birmingham, Alabama, United States, 35209
2
Leo Pharma Investigational site
North Little Rock, Arkansas, United States, 72117
3
Leo Pharma Investigational site
Palo Alto, California, United States, 94304
4
Leo Pharma Investigational site
Sacramento, California, United States, 95816