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

NCT06640517 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: BCD-085-16
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects achieving PASI75

  PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

  Week 12

• Proportion of subjects achieving sPGA0/1

  Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.

  Week 12

Secondary Outcomes (13)

• Proportion of subjects achieving PASI75

  Week 58, Week 102

• Proportion of subjects achieving sPGA0/1

  Week 58, Week 102

• Proportion of subjects achieving IGA mod 2011 0/1

  Week 12, Week 58, Week 102

• Proportion of subjects achieving PASI90

  Week 12, Week 58, Week 102

• Proportion of subjects achieving PASI100

  Week 12, Week 58, Week 102

Other Outcomes (5)

• Mean change in the PSSI score from baseline (for subjects with PSSI>0 at baseline)

  Week 12, Week 58, Week 102

• Mean change in the PPASI score from baseline (for subjects with PPASI>0 at baseline)

  Week 12, Week 58, Week 102

• Mean change in the mGPASI score from baseline (for subjects with mGPASI>0 at baseline)

  Week 12, Week 58, Week 102

Study Arms (3)

NTK

EXPERIMENTAL

netakimab given subcutaneously during main period, open-label period and treatment discontinuation period

Drug: Netakimab

PBO

PLACEBO COMPARATOR

placebo given subcutaneously during main period and treatment discontinuation period

Drug: Placebo

ADA

ACTIVE COMPARATOR

adalimumab given subcutaneously during main period

Drug: Adalimumab

Interventions

Netakimab DRUG

netakimab will be administered subcutaneously with induction once a week for the first three weeks, then once every 4 weeks

NTK

Placebo DRUG

placebo will be administered subcutaneously at a scheme masking netakimab treatment

PBO

Adalimumab DRUG

adalimumab will be administered subcutaneously at weeks 1, 2, and then once every 2 weeks

ADA

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• The ability of the subject and his/her legal representative, in the Investigator's opinion, to perceive information and follow the Protocol procedures.
• Willingness of subjects and their sexual partners of childbearing potential to use highly effective methods of contraception from the signing of the ICF to 12 weeks after the last dose of the investigational product. This requirement does not apply to subjects who have not reached sexual maturity or who have undergone surgical sterilization. The subject's legal representative must consent to the subject's use of contraception.

You may not qualify if:

• \. Erythrodermic, pustular, guttate psoriasis, drug-induced psoriasis or any other skin diseases (e.g. eczema) at screening that can affect/complicate the assessment of psoriasis treatment with the investigational product.
• \. Use of the following medications:
• 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.
• \. Recurrent, chronic, or any other active infection in which, in the opinion of the Investigator, the investigational product may harm the study subject.
• \. Sepsis or risk of sepsis. 5. Positive HIV-1 or HIV-2 test. 6. HBV/HCV infections (for details, see Section 6.5.7.2). 7. Established diagnosis or a history of immunodeficiency syndrome (e.g., severe combined immunodeficiency syndrome, T and B cell deficiency syndromes, chronic granulomatous disease), or an infection characteristic of an immunodeficiency (e.g., pneumocystis pneumonia, histoplasmosis or coccidioidomycosis) at the time of signing the ICF.
• \. Diagnosis of tuberculosis, including a history of tuberculosis. 9. A clinically significant infection caused by the varicella-zoster virus within 12 weeks prior to signing the ICF.
• \. Body temperature ≥38°C at the screening. These subjects may be re-screened, but not earlier than 4 weeks after the first screening.
• \. Other concomitant medical conditions that continued at the time of the screening examination, which increase the risk of adverse events during the study or may affect the evaluation of psoriasis symptoms, mask, enhance, or alter the symptoms of psoriasis, or cause clinical or laboratory symptoms similar to those of psoriasis and confirmed by the source documentation:
• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (14)

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

Barnaul, Russia

Location

State budgetary healthcare institution "Chelyabinsk Regional Clinical Dermatovenerological Dispensary"

Chelyabinsk, Russia

Location

Limited Liability Company "Health Azbuka Medical Center"

Kazan', Russia

Location

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

Kazan', Russia

Location

State Autonomous Healthcare Institution "Kuzbass Clinical Dermatovenerological Dispensary"

Kemerovo, Russia

Location

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

Kirov, Russia

Location

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

Krasnodar, Russia

Location

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

Moscow, Russia

Location

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

Location

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

Location

Limited Liability Company "PiterKlinika"

Saint Petersburg, Russia

Location

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

Tomsk, Russia

Location

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

Tomsk, Russia

Location

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

Yekaterinburg, Russia

Location

MeSH Terms

Interventions

netakimab; Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (14)