Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With… (NCT06640517) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis
Russia140 participantsStarted 2024-08-08
Plain-language 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.
Who can participate
Age range
6 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent of the legal representative and the subject to participate in the study (the study subject signs the appendix to the information sheet for the legal representative of the clinical study subject with informed consent form).
. For Stage 1 only: age ≥12 and \<18 years at the time of randomization.
. For Stage 2 only: age ≥6 and \<12 years at the time of randomization.
. A diagnosis of moderate to severe plaque psoriasis with a disease duration of the disease being at least 3 months before the signing of the ICF.
. Subjects who are candidates for phototherapy or systemic therapy for psoriasis (including non-responders to systemic therapy or phototherapy), in the opinion of the Investigator, or who did not achieve adequate disease control with topical agents.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. At the time of the screening examination, the body surface area affected by psoriasis is \>10% of the body surface area (BSA), the Psoriasis Area and Severity Index (PASI) score is ≥12, and the static Physician's Global Assessment (sPGA) score is ≥3.
. Subjects with the normal laboratory test results at screening.
. Subjects with a negative whole blood IFN-γ release test.
Exclusion criteria
. Prior use of drugs based on monoclonal antibodies against interleukin-17 or its receptor.
. Prior use of adalimumab.
. Prior use of monoclonal antibodies or their fragments within 12 weeks before signing the ICF.
. Use of systemic non-biological medicinal products including methotrexate, sulfasalazine, cyclosporine or acitretin within 4 weeks prior to the date of signing the ICF. If previously used systemic non-biologic drugs are discontinued for any reason, the screening period can be extended for up to 8 calendar weeks, during which new systemic non-biologic drugs are not prescribed.
. Use of phototherapy (including selective phototherapy \[UV-B\] and photochemotherapy \[PUVA\]) less than 4 weeks before the date of signing the ICF.
. Vaccination with live vaccines at any time within 12 weeks prior to signing the ICF or an expected need for such vaccination during the study.
. Active inflammatory diseases or aggravation of chronic inflammatory diseases other than psoriasis.
. Functional class III-IV stable angina of effort, unstable angina or a history of myocardial infarction within 1 year before signing the IC.