Atopic dermatitis
Conditions
Interventions
Name of IMP: Tralokinumab
Active substance:
Dosage form: Syringe/vials
Concentration: 150mg/mL
Dose and method of administration:
Dose regimen for cohort 1 (6 to =40 kg 17-=40 kg
Loading dose (Visit
Sponsors
Leo Pharma
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD). • Age 6 to =17 kg for children aged 6 to = 12 months for children aged 6 to =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.
Exclusion criteria
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: o Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors). o Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery). o 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): o 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. o Other biologics (including dupilumab): within 3 months or 5 half-lives, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Ctrough at Week 16. • Cmax between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W). • AUC between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W). • Tmax between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of treatment*emergent adverse events in the initial treatment period (Week 0-Week 16). • Anti-drug antibodies (status) in the initial treatment period (Week 0-Week 16). • Number of treatment*emergent adverse events in the open-label treatment period (Week 16-Week 68). • Anti-drug antibodies (status) in the open-label treatment period (Week 16-Week 68). • Change in SCORAD from Week 0 - Week 68. • Change in POEM from Week 0 - Week 68. • Change in EASI from Week 0 to Week 68. | — |
Countries
Netherlands
Outcome results
None listed