BCD-085-16/PLANETA-KIDS is a randomized, double blind, placebo-controlled study of the efficacy, safety, pharmacokinetics and immunogenicity of netakimab in children with moderate to severe plaque psoriasis.
The BCD-085-16/PLANETA-KIDS clinical trial will evaluate the efficacy and safety of netakimab compared to placebo in a pediatric population of subjects who:
Have reached the age of 6 years, but have not reached the age of 12 years:
Enrollment status: Pre-screening
Have confirmed moderate to severe plaque psoriasis with the duration of the disease of not less than 3 months before signing the informed consent.
Agree to use reliable methods of contraception throughout the study and for 3 months after. This requirement does not apply to patients who have not reached puberty or who have undergone surgical sterilization. The patient's legal representative will need to express consent to the patient's compliance with contraceptive methods.
Are candidates for phototherapy or systemic therapy for psoriasis (including those who have not responded to systemic therapy or phototherapy), in the opinion of the study physician, or those who have not achieved adequate disease control by using topical agents.
Have reached the age of 12 years, but have not reached the age of 18 years:
Enrollment status: Conducted
Have confirmed moderate to severe plaque psoriasis with the duration of the disease of not less than 3 months before signing the informed consent.
Agree to use reliable methods of contraception throughout the study and for 3 months after. This requirement does not apply to patients who have not reached puberty or who have undergone surgical sterilization. The patient's legal representative will need to express consent to the patient's compliance with contraceptive methods.
Are candidates for phototherapy or systemic therapy for psoriasis (including those who have not responded to systemic therapy or phototherapy), in the opinion of the study physician, or those who have not achieved adequate disease control by using topical agents.
This study has exclusion criteria (criteria for non-eligibility for participation in a specific clinical trial), the full list of which will be communicated to the potential participant by the Investigator. In particular, the exclusion criteria are:
Erythrodermic, pustular, guttate, or drug-induced psoriasis or any other pathological skin changings (e.g. eczema) at screening that can affect/complicate the assessment of psoriasis treatment with the investigational drug.
Using the following drugs for therapy:
Previous use of drugs based on monoclonal antibodies against interleukin-17 or its receptor.
Previous use of adalimumab.
Previous use of monoclonal antibodies and their fragments in case if the interval between the end of therapy and signing the informed consent is less then 12 weeks.
Use of systemic non-biological drugs, including methotrexate, sulfasalazine, cyclosporine or acitretin within 4 weeks before the date of signing the informed consent. If previously used systemic non-biological drugs were discontinued for any reason, the screening period may be increased to 8 calendar weeks, during which new systemic non-biological 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 informed consent.
Vaccination with live vaccines at any time within 12 weeks before signing the informed consent or the expected need for such vaccination during the clinical trial.
Confirmed diagnosis of tuberculosis, including a history of tuberculosis.
The BCD-085-16/PLANETA-KIDS study takes place in research centers in different cities of the Russian Federation, such as Kazan, Moscow, St. Petersburg, Chelyabinsk, Kirov, Kazan, Krasnodar, Barnaul, Ryazan, Saratov and others.
You can ask questions about your participation in the clinical trial, including clarifying the study center contact information, using the “Do you have any questions?” form.
The study physician will tell the potential participant about other selection criteria and contraindications for participation in this clinical trial, as well as about other drugs used in the study. Potential participants need to familiarize themselves with the complete study information and consult with the study physician and/or treating physician.
The Permission from the Ministry of Health of the Russian Federation to conduct this clinical trial No. 194 dated May 21, 2024 and a list of approved study centers are published in the State register of medicines.