LP0162-1335: A single (assessor) blinded, randomized, parallel-group, monotherapy trial to evaluate the pharmacokinetics and safety of tralokinumab in children (age 6 to <12 years) with moderate to-severe atopic dermatitis. - TRAPEDS 1 (TRAlokinumab PEDiatric trial no. 1).
Date de révision : 12/05/2026
Homme Femme
Jusqu'à 17 ans
Date de début de recrutement : 23/10/2024
Date de fin de recrutement : 23/10/2024
Critères :
Critères d'inclusion :
- 1. Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
- 2. Age 6 to <12 years.
- 3. Body weight at baseline of ≥17 kg.
- 4. History of AD for ≥ 12 months at screening.
- 5. 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.
- 6. AD involvement of ≥10% body surface area at screening and baseline.
- 7. An EASI score of ≥16 at screening and at baseline.
- 8. An IGA score of ≥3 at screening and at baseline.
- 9. Emollient twice daily (or more) for at least 14 days prior to baseline.
Critères d'exclusion :
- 1. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- 10. History of past or current tuberculosis or other mycobacterial infection.
- 11. Established diagnosis of a primary immunodeficiency disorder.
- 2. Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
- 3. Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline: 3a. Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors). 3b. Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery). 3c. 3 or more bleach baths during any week within the 4 weeks.
- 4. Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab): 4a. 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. 4b. Other biologics (including dupilumab): within 3 months or 5 half-lives, whichever is longer, prior to baseline.
- 5. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit.
- 6. History of malignancy at any time before the baseline visit.
- 7. History of anaphylaxis following any biological therapy.
- 8. History of immune complex disease.
- 9. Active or suspected endoparasitic infections (including helminthic infections).
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