Tralokinumab monotherapy for children with moderate-to-severe atopic dermatitis. TRAPEDS 1 (TRAlokinumab PEDiatric trial no. 1)

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-005573-12-NL
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-09
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

- Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
- Age 2 to <12 years.
- Body weight at baseline:
- =9 kg for children aged 2 to <6 years at screening.
- =17 kg for children aged 6 to <12 years at screening.
- History of AD for:
- = 3 months for children aged 2 to <6 years at screening.
- = 12 months for children aged 6 to <12 years 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 IGA score of =3 at screening and at baseline.
- Emollient twice daily (or more) for at least 14 days prior to baseline.
Are the trial subjects under 18? yes
Number of subjects for this age range: 53
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified