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

Sponsor
Biocad
Study ID
NCT06640517
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 8, 2024
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Feb 29, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NTK
    netakimab given subcutaneously during main period, open-label period and treatment discontinuation period
  • Placebo Comparator: PBO
    placebo given subcutaneously during main period and treatment discontinuation period
  • Active Comparator: ADA
    adalimumab given subcutaneously during main period

Primary Outcome Measure

Proportion of subjects achieving PASI75 [ Time Frame: Week 12 ]

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