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Tralokinumab monotherapy in children with moderate-to-severe atopic dermatitis
NL-OMON59637Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2022
- Countries
- 1
- Sponsor
- LEO Pharma
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Drugs
- tralokinumab
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 2, open-label trial of tralokinumab in atopic dermatitis (AD) (3 cohorts), sponsored by LEO Pharma. Primary endpoints: Ctrough at Week 16, Cmax and 2 more. Started Aug 2022; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Tralokinumab high-dose cohort
Participants receiving a higher tralokinumab dose regimen; exact dose not provided in the source text.
Tralokinumab low-dose every-2-weeks cohort
Participants receiving low-dose tralokinumab every 2 weeks.
Tralokinumab low-dose every-4-weeks cohort
Participants receiving low-dose tralokinumab every 4 weeks.
03
Who it enrols
Children aged 6 to under 12 years with chronic moderate-to-severe atopic dermatitis were eligible if they had substantial disease burden (BSA at least 10%, EASI at least 16, IGA at least 3), body weight at least 17 kg, and prior failure, intolerance, or medical inadvisability of topical corticosteroids and/or topical calcineurin inhibitors. Recent topical PDE-4 inhibitors, systemic immunomodulators, systemic corticosteroids, biologics, active infections requiring systemic therapy, malignancy history, tuberculosis or mycobacterial infection, primary immunodeficiency, anaphylaxis to biologics,…
04
Endpoints
Primary
Ctrough at Week 16
Cmax
AUC
Tmax
Secondary
Treatment-emergent adverse events during initial treatment period
Anti-drug antibodies during initial treatment period
Treatment-emergent adverse events during open-label treatment period
Anti-drug antibodies during open-label treatment period
Treatment-emergent adverse events during long-term extension
Anti-drug antibodies during long-term extension
Change in SCORAD
Change in POEM
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