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Plaque PsoriasisPhase 3PLANETA-KIDSNCT06640517

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

A Phase 3 study testing Netakimab and Adalimumab in people with Plaque Psoriasis, run by Biocad at 14 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Netakimab and Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
14 sitesRussia
Study dates
8 Aug 2024to Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 1. 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.
  • 2. 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.
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  • 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.
  • 3. Recurrent, chronic, or any other active infection in which, in the opinion of the Investigator, the investigational product may harm the study subject.
  • 4. 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.
  • 8. 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.
  • 10. Body temperature ≥38°C at the screening. These subjects may be re-screened, but not earlier than 4 weeks after the first screening.
  • 11. 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.
  • Moderate to severe cardiac failure (NYHA class III-IV).
  • Grade 2 hypertension.
  • A history of atopic asthma, angioedema.
  • Moderate to severe respiratory failure, Grade 3/4 chronic obstructive pulmonary disease.
  • Decompensated diabetes mellitus; decompensated hypothyroidism, decompensated thyrotoxicosis.
  • Significant systemic autoimmune diseases according to the Investigator.
  • A history of Crohn's disease, ulcerative colitis.
  • Any other underlying conditions (including but not limited to metabolism, hematology, renal, hepatic, pulmonary, neurological, endocrine, cardiac, and gastrointestinal disorders; infections) that may, in the Investigator's opinion, affect the course of psoriasis, affect the assessment of its symptoms, or put the subject using the study therapy at unacceptable risk.
  • 12. Malignant and lymphoproliferative diseases, including lymphoma; symptoms indicating the development of a lymphoproliferative disease (such as lymphadenopathy and/or splenomegaly), except for those previously excluded by a biopsy.
  • 13. History of allergic reactions (anaphylactic shock or allergy to 2 or more drugs).
  • 14. Known allergy or intolerance to monoclonal antibody products or any components of the investigational product.
  • 15. Major surgery within 30 days before the screening, or a major surgery scheduled at any time during the study.
  • 16. Severe infections (including those that required hospitalization or parenteral antibacterial, antimycotic, or antiprotozoal agents) within 6 months prior to signing the ICF.
  • 17. Use of systemic antibacterial, antimycotic, or antiprotozoal agents within 2 months before signing the ICF.
  • 18. More than 4 episodes of respiratory infections over the past 6 months prior to signing the ICF.
  • 19. Any concomitant diseases in which, in the Investigator's opinion, the study therapy may harm the subject.
  • 20. Signs of premature puberty at the screening examination. 21. Pregnancy, breastfeeding, or planning pregnancy while participating in the study.
  • 22. Any psychiatric disorder, including a history of severe depressive disorders and/or suicidal thoughts, which, in the opinion of the Investigator, may pose an excessive risk to the subject or affect the subject's ability to follow the Protocol.
  • 23. Drug addiction, alcoholism, or abuse with drugs or other psychoactive substances (including a history of such disorders).
  • 24. Simultaneous participation in other clinical studies, as well as previous participation in other clinical studies less than 3 months before signing the ICF, prior participation in this study.
  • 25. Use of any other investigational products at the time of signing the ICF or less than 28 days before the planned date of signing the ICF or 5 half-lives (whichever is longer) before the date of signing the ICF.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Russia14 sites

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

    Barnaul

  • State budgetary healthcare institution "Chelyabinsk Regional Clinical Dermatovenerological Dispensary"

    Chelyabinsk

  • Limited Liability Company "Health Azbuka Medical Center"

    Kazan'

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

    Kazan'

  • State Autonomous Healthcare Institution "Kuzbass Clinical Dermatovenerological Dispensary"

    Kemerovo

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

    Kirov

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

    Krasnodar

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

    Moscow

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

    Nizhny Novgorod

  • 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

  • Limited Liability Company "PiterKlinika"

    Saint Petersburg

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

    Tomsk

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

    Tomsk

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

    Yekaterinburg

Other trials in Russia

About this study

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

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.

Read the detailed description

Following screening, subjects will be randomized to receive either netakimab, placebo or adalimumab and enter the main study period.

During the main study period, subjects will receive therapy with netakimab/placebo (double-blind arms) or adalimumab (open-label arm), which will be administered subcutaneously until week 12.

At Week 12, after completion of all scheduled procedures subjects in groups netakimab/placebo will continue to receive open-label netakimab for up to week 58, subjects in group adalimumab will switch to open-label adalimumab after 8-week "washout" period.

At Week 58, after completion of all scheduled procedures subjects with sPGA ≤1 will be re-randomised to recieve either netakimab or placebo in double-blind maner. The subjects with >1 will continue to recieve open-label netakimab.

Being tested
Netakimab, Placebo, Adalimumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NetakimabDrug

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

  • PlaceboDrug

    placebo will be administered subcutaneously at a scheme masking netakimab treatment

  • AdalimumabDrug

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

Study groups in NCT06640517
Study groupRoleWhat they receive
NTKExperimentalnetakimab given subcutaneously during main period, open-label period and treatment discontinuation period
Receives: Drug: Netakimab
PBOPlacebo comparatorplacebo given subcutaneously during main period and treatment discontinuation period
Receives: Drug: Placebo
ADAActive comparatoradalimumab given subcutaneously during main period
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 12

  2. 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.

    Measured: Week 12

Secondary outcomes (13)

  1. 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 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).

    Measured: Week 58, Week 102

  2. 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.

    Measured: Week 58, Week 102

  3. Proportion of subjects achieving IGA mod 2011 0/1

    Investigator Global Assessment (IGA) mod 2011 provide the assessment of the disease severity from a score of 0 (clear skin) to 4 (severe disease)

    Measured: Week 12, Week 58, Week 102

  4. Proportion of subjects achieving PASI90

    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 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).

    Measured: Week 12, Week 58, Week 102

  5. Proportion of subjects achieving PASI100

    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 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).

    Measured: Week 12, Week 58, Week 102

  6. Proportion of subjects achieving sPGA0

    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.

    An sPGA assessed as 0 represents a clinically important endpoint indicating complete resolution of plaque psoriasis.

    Measured: Week 12, Week 58, Week 102

  7. Mean change in the PASI score from baseline

    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 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).

    Measured: Week 12, Week 58, Week 102

  8. Mean change in the Nail Psoriasis Severity Index NAPSI from baseline (for subjects with NAPSI>0 at baseline)

    NAPSI is a numeric, reproducible, objective tool for evaluation of nail psoriasis. This scale was used to evaluate the severity of nail bed psoriasis \& nail matrix psoriasis by area of involvement in the nail unit. Both fingernail \& toenail involvement were assessed.The nail is divided with imaginary horizontal \& longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0 to 4) \& nail matrix psoriasis (0 to 4), depending on the presence (score of 1) or absence (score of 0) of any of the features of nail bed \& nail matrix psoriasis in each quadrant:

    0 = None

    1. = present in one quadrant of nail
    2. = present in two quadrants of nail
    3. = present in three quadrants of nail
    4. = present in four quadrants of nail NAPSI score of a nail is the sum of scores in nail bed \& nail matrix from each quadrant (maximum of 8). Each nail is evaluated, \& the sum of all the fingernails and toenails is the total NAPSI score ranging from 0 to 160 (No to Severe nail Psoriasis)

    Measured: Week 12, Week 58, Week 102

  9. Mean change in the pruritus severity score on the numerical rating scale (NRS) from baseline.

    Itch Numeric Rating Scale (NRS): is a single-item, patient-reported outcome (PRO) measure designed to capture the overall severity of a participant's itching due to his/her psoriasis by having the patient circle the integer that describes the worst level of itching in the past 24 hours on an 11-point NRS anchored at 0 representing "no itching" and 10 representing "worst itch imaginable.

    Measured: Week 12, Week 58, Week 102

  10. Time to relapse defined as sPGA≥2 during the treatment discontinuation period

    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.

    Measured: Week 58 through Week 102

  11. Safety assessment

    The subjects will be examined for vital signs (blood pressure (BP), wrist pulse rate, axial body temperature) and undergo a physical and instrumental examination, complete blood count, blood chemistry, and urinalysis; the presence and characteristics of adverse events will also be determined. Body weight, height and body mass index will be compared with the World Health Organization's reference values for the physical development of children and adolescents

    Measured: Through Week 124

  12. Immunogenicity assessment

    Proportion of subjects with detected binding and/or neutralizing antibodies to netakimab.

    Measured: Through Week 102

  13. Pharmacokinetics assessment

    Multiple dosing pharmacokinetics will be assessed via Ctrough calculation

    Measured: Through Week 102

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start8 Aug 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06640517
Sponsor's protocol ID
BCD-085-16
Acronym
PLANETA-KIDS
Status last verified
May 2026
First submitted
11 Oct 2024
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Netakimab and Adalimumab in people with Plaque Psoriasis, run by Biocad at 14 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects achieving PASI75 (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06640517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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