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Biosimilar showdown: can GNR-068 match stelara for psoriasis?

NCT ID NCT06488664

NEW Disease control Sponsor: AO GENERIUM Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether GNR-068, a ustekinumab biosimilar, works as well as the reference drug Stelara in adults with moderate to severe plaque psoriasis. About 422 participants receive either GNR-068 or Stelara as injections over several months, and everyone eventually receives GNR-068. The study measures how many people achieve at least a 75% improvement in psoriasis severity and tracks safety and long-term effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GNR-068, a ustekinumab biosimilar
What this could lead to
If GNR-068 works as well as Stelara, it could offer another treatment option for people with moderate to severe plaque psoriasis.
What could go wrong
Biosimilars can differ slightly from the original drug, and this trial may show GNR-068 is not as effective or as safe as Stelara. Results may not apply to everyone with psoriasis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

422 people

The number who actually took part.

Started

Jul 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent to participate in the study. * Men and women 18-75 years of age, inclusive, at the time of signing the informed consent form. * Patients diagnosed with plaque psoriasis at least 6 months before screening: 1. Moderate or severe form of the disease, which is defined as: PASI index ≥12, body surface area (BSA) affected by plaque psoriasis, ≥10%, PGA scale score ≥3 (on a scale from 0 to 4). 2. Presence of indications for systemic therapy, defined as inadequate control of the disease against the background of: local treatment (including local glucocorticosteroids) and/or phototherapy and/or lack of clinical effect from the use of other systemic methods. 3. It is acceptable to carry out basic therapy for psoriatic arthritis at a stable dose for ≥ 4 weeks before screening: prednisolone at a dose of ≤10 mg per day, NSAIDs, methotrexate at a dose of ≤15 mg per week, sulfasalazine at a dose of 2.0 g per day. * Body weight less than 100 kg. * If it is necessary to take drugs that worsen the course of psoriasis (beta blockers, calcium channel blockers, lithium drugs, etc.): a stable dose of these drugs for ≥ 4 weeks before randomization. * Consent of women of childbearing age, women in menopause lasting less than 2 years and male patients to comply with adequate methods of contraception throughout the study and for 3 months after the end of ustekinumab therapy. * Patients should not be donors of blood or its components 30 days before inclusion in the study and not become donors of blood or its components throughout the study and for 3 months after its completion. Exclusion Criteria: * Types of psoriasis other than plaque, except for concomitant psoriatic arthritis. * History of therapy with ustekinumab or any therapy aimed at IL-12 or IL-23 (briakinumab, guselkumab, tildrakizumab). * Therapy with TNF-alpha inhibitors or any other genetically engineered biological drugs within 3 months before randomization. * Conducting other systemic therapies (including cyclosporine, acitretin, methotrexate, UV and PUVA therapy) within 1 month before randomization. * Treatment with leflunomide for 6 months before randomization. * Spread of the inflammatory process involving the gastrointestinal tract (inflammatory bowel diseases), the organ of vision (uveitis, iridocyclitis), musculoskeletal structures (high activity of psoriatic arthritis, osteoarthritis, uncontrolled against the background of basic therapy (clause 3 Inclusion criteria) ). * Major surgery (including joint surgery) within 8 weeks before the start of the study or elective surgery within 6 months after the start of the study. * A history of an adverse drug reaction to any of the components of the study drug or a reference drug. * Immunization with any live or live attenuated vaccine within 1 month before the first dose of the study drug or comparator drug. * A history of a disease associated with the accumulation of immune complexes that may distort the assessment of the effectiveness of ustekinumab therapy (including serum sickness, systemic lupus erythematosus, rheumatoid arthritis, polymyositis, scleroderma, Sjogren's syndrome, vasculitis, cryoglobulinemia). * Concomitant diseases and conditions that, in the opinion of the Investigator and/or Sponsor, jeopardize the safety of the patient during participation in the study, or which will influence the analysis of safety data. * Active systemic infection (bacterial, viral or fungal) within 14 days before signing the informed consent. * Pregnancy or breastfeeding. * History of tuberculosis, positive/doubtful result of screening for tuberculosis infection (tuberculosis allergen test or IGRA test or fluorography results). Inclusion of such patients is possible if effective specific treatment for tuberculosis infection has been carried out and there is a conclusion from a phthisiatrician about the possibility of ustekinumab therapy. * Participation in clinical trials of drugs less than 5 half-lives of the study drug before signing the informed consent. * Positive test for hepatitis B or C, HIV or syphilis. * Unwillingness or inability to comply with the recommendations prescribed by this protocol. * Identification during screening of other diseases/conditions not listed above that, in the opinion of the physician-researcher, prevent the inclusion of the patient in the study.

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plaque psoriasis

Contacts and locations

Locations

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

    Barnaul, Barnaul, 656038, Russia

  • Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation (FSBEI HE Kirov State Medical University of the Ministry of Health of Russia))

    Kirov, Kirov Oblast, 610027, Russia

  • Federal State Budgetary Educational Institution of Higher Education "Russian University of Medicine" of the Ministry of Health of the Russian Federation (FSBEI HE "Russian University of Medicine" of the Ministry of Health of Russia)

    Moscow, Moscow, 127006, Russia

  • Federal State Budgetary Educational Institution of Higher Education Orenburg State Medical University of the Ministry of Health of Russia

    Orenburg, Orenburg Oblast, 460018, Russia

  • Federal State Budgetary Institution "Research Institute of Rheumatology named after V.A. Nasonova"

    Moscow, Moscow, 115522, Russia

  • Limited Liability Company "Alliance Biomedical - Ural Group"

    Izhevsk, Izhevsk, 426061, Russia

  • Limited Liability Company "ArsVite North-West"

    Saint Petersburg, Sankt-Peterburg, 196191, Russia

  • Limited Liability Company "Available Polyclinic"

    Murino, Leningradskaya Oblast', 188678, Russia

  • Limited Liability Company "Clinic of Skin Diseases Pierre Wolkenstein"

    Saint Petersburg, Sankt-Peterburg, 191123, Russia

  • Limited Liability Company "Curator"

    Saint Petersburg, Sankt-Peterburg, 196240, Russia

  • Limited Liability Company "Ecology of Health"

    Chelyabinsk, Chelyabinsk Oblast, 454126, Russia

  • Limited Liability Company "Family Clinic No. 4"

    Korolyov, Moscow Oblast, 141060, Russia

  • Limited Liability Company "Firma ORIS"

    Moscow, Moscow, 117321, Russia

  • Limited Liability Company "Health Energy"

    Saint Petersburg, Sankt-Peterburg, 194156, Russia

  • Limited Liability Company "Institute of Medical Research"

    Saint Petersburg, Sankt-Peterburg, 196084, Russia

  • Limited Liability Company "Interleukin"

    Saint Petersburg, Sankt-Peterburg, 194214, Russia

  • Limited Liability Company "International Medical Center"

    Saint Petersburg, Sankt-Peterburg, 191123, Russia

  • Limited Liability Company "MEDINET"

    Saint Petersburg, Sankt-Peterburg, 197136, Russia

  • Limited Liability Company "Medical Center "Healthy Family"

    Novosibirsk, Novosibirsk Oblast, 630099, Russia

  • Limited Liability Company "Medical Technologies" LLC "Medical Technologies"

    Saint Petersburg, Sankt-Peterburg, 192148, Russia

  • Limited Liability Company "OLLA-MED"

    Moscow, Moscow, 105554, Russia

  • Limited Liability Company "PiterKlinika"

    Saint Petersburg, Sankt-Peterburg, 196158, Russia

  • Limited Liability Company "Research Center Eco-Safety"

    Saint Petersburg, Sankt-Peterburg, 196143, Russia

  • Limited Liability Company "SB Clinic of Cosmetology"

    Saratov, Saratov Oblast, 410012, Russia

  • Limited Liability Company Medical Center "Azbuka Health"

    Kazan', Tatarstan Republic, 420111, Russia

  • Private medical institution "Euromedservice"

    Saint Petersburg, Sankt-Peterburg, 196603, Russia

  • Regional state budgetary healthcare institution "Smolensk Dermatovenerological Dispensary"

    Smolensk, Smolensk Oblast, 214031, Russia

  • State Budgetary Healthcare Institution Ulyanovsk area Clinical Hospital

    Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

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

    Chelyabinsk, Chelyabinsk Oblast, 454048, Russia

  • State budgetary healthcare institution of the Moscow region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"

    Moscow, Moscow, 129110, Russia

  • State budgetary healthcare institution of the city of Moscow "Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Health Department"

    Moscow, Moscow, 119071, Russia

  • State budgetary institution of the Ryazan region "Regional clinical dermatovenerological dispensary"

    Ryazan, Ryazan Oblast, 390046, Russia

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

    Yekaterinburg, Ekaterinburg, 620076, Russia

  • State health care institution "Regional Dermatovenerological Dispensary"

    Lipetsk, Lipetsk Oblast, 398005, Russia

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