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ACTIVE NOT RECRUITING
NCT06640517
PHASE3

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

Sponsor: Biocad

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-08-08

Completion Date

2028-02

Last Updated

2025-06-24

Healthy Volunteers

No

Interventions

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

Locations (14)

Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University" of the Ministry of Health of the Russian Federation

Barnaul, Russia

State budgetary healthcare institution "Chelyabinsk Regional Clinical Dermatovenerological Dispensary"

Chelyabinsk, Russia

Limited Liability Company "Health Azbuka Medical Center"

Kazan', Russia

State Autonomous Healthcare Institution "Republic Clinical Dermatovenerologic Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor Ge"

Kazan', Russia

State Autonomous Healthcare Institution "Kuzbass Clinical Dermatovenerological Dispensary"

Kemerovo, Russia

Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation

Kirov, Russia

State budgetary healthcare institution "Clinical Dermatovenerologic Dispensary" of the Ministry of Health of the Krasnodar Territory

Krasnodar, Russia

Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation

Moscow, Russia

Federal State Budgetary Institution "State scientific centre of dermatovenerology and cosmetology" of the Ministry of health of Russian Federation, Nizhny Novgorod branch

Nizhny Novgorod, Russia

Federal State Budgetary Educational Institution of Higher Education "St. Petersburg State Pediatric Medical University" of the Ministry of Health of the Russian Federation

Saint Petersburg, Russia

Limited Liability Company "PiterKlinika"

Saint Petersburg, Russia

Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation

Tomsk, Russia

Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"

Tomsk, Russia

State budgetary institution of the Sverdlovsk region "Ural Research Institute of Dermatovenereology and Immunopathology"

Yekaterinburg, Russia