Status:
ACTIVE_NOT_RECRUITING
Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
Lead Sponsor:
LEO Pharma
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
Brief Summary
The main purpose of this trial is to investigate what happens to the trial drug in the body and to confirm that it is safe to use and effective for treating atopic dermatitis (AD) in children. The tr...
Eligibility Criteria
Inclusion
- Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
- Age 6 to \<12 years at time of the baseline visit.
- Body weight at baseline of ≥17 kg.
- History of AD for ≥ 12 months at screening.
- History of TCS and/or TCI treatment failure (due to inadequate response or intolerance) or subjects for whom these topical AD treatments are medically inadvisable.
- AD involvement of ≥10% body surface area at screening and baseline.
- An EASI score of ≥16 at screening and at baseline.
- An Investigator's Global Assessment (IGA) score of ≥3 at screening and at baseline.
- Emollient twice daily (or more) for at least 14 days prior to baseline.
Exclusion
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
- Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline:
- Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors).
- Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery).
- 3 or more bleach baths during any week within the 4 weeks.
- Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab):
- Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
- Other biologics (including dupilumab): within 3 months or 5 halflives, whichever is longer, prior to baseline.
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit.
- History of malignancy at any time before the baseline visit.
- History of anaphylaxis following any biological therapy.
- History of immune complex disease.
- Active or suspected endoparasitic infections.
- History of past or current tuberculosis or other mycobacterial infection.
- Established diagnosis of a primary immunodeficiency disorder.
Key Trial Info
Start Date :
September 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 23 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05388760
Start Date
September 7 2022
End Date
April 23 2026
Last Update
November 5 2025
Active Locations (11)
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1
LEO Pharma Investigational Site
Brno, Czechia, 625 00
2
LEO Pharma Investigational Site
Prague, Czechia, 150 06
3
LEO Pharma Investigational Site
Reims, Ardennes, France, 51100
4
LEO Pharma Investigational Site
Rotterdam, Netherlands, 3011 TG