NCT06640517

Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the efficacy and safety of netakimab compared with placebo in a pediatric population of subjects over 6 years of age with moderate to severe plaque psoriasis. The study will have randomized, double-blind, placebo-controlled study with open-arm comparison.

Detailed description

Following screening, subjects will be randomized to receive either netakimab, placebo or adalimumab in a 2:1:2 ratio and enter the main study period. During the main study period, subjects will receive therapy with netakimab/placebo (double-blind arms) or adalimumab (open-label arm), which will be administered subcutaneously until week 12. At Week 12, after completion of all scheduled procedures subjects in groups netakimab/placebo will continue to receive open-label netakimab for up to week 58, subjects in group adalimumab will switch to open-label adalimumab after 8-week "washout" period. At Week 58, after completion of all scheduled procedures subjects with sPGA ≤1 will be re-randomised to recieve either netakimab or placebo in double-blind maner. The subjects with \>1 will continue to recieve open-label netakimab.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Netakimab	netakimab will be administered subcutaneously with induction once a week for the first three weeks, then once every 4 weeks
DRUG	Placebo	placebo will be administered subcutaneously at a scheme masking netakimab treatment
DRUG	Adalimumab	adalimumab will be administered subcutaneously at weeks 1, 2, and then once every 2 weeks

Timeline

• Start date: 2024-08-08
• Primary completion: 2026-06-01
• Completion: 2028-02-01
• First posted: 2024-10-15
• Last updated: 2025-06-24

Locations

14 sites across 1 country: Russia