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Plaque PsoriasisPhase 3NCT06488664

An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis

A Phase 3 study testing GNR-068 and Stelara® in people with Plaque Psoriasis, run by AO GENERIUM at 34 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized single-blind comparative parallel group efficacy and safety study of ustekinumab biosimilar GNR-068 (45 mg) and reference product Stelara® (45 mg) in the treatment of patients with moderate and severe forms of plaque psoriasis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
GNR-068 and Stelara®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
422 participants
Where
34 sitesRussia
Study dates
25 Jul 2023to 26 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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).
  • 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.
  • 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.
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  • 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.

Who cannot join

  • 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) ).
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  • 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.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

Russia34 sites

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

    Barnaul, Barnaul, 656038

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

    Chelyabinsk, Chelyabinsk Oblast, 454048

  • Limited Liability Company "Ecology of Health"

    Chelyabinsk, Chelyabinsk Oblast, 454126

  • Limited Liability Company "Alliance Biomedical - Ural Group"

    Izhevsk, Izhevsk, 426061

  • Limited Liability Company Medical Center "Azbuka Health"

    Kazan', Tatarstan Republic, 420111

  • 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

  • Limited Liability Company "Family Clinic No. 4"

    Korolyov, Moscow Oblast, 141060

  • State health care institution "Regional Dermatovenerological Dispensary"

    Lipetsk, Lipetsk Oblast, 398005

  • Limited Liability Company "OLLA-MED"

    Moscow, Moscow, 105554

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

    Moscow, Moscow, 115522

  • Limited Liability Company "Firma ORIS"

    Moscow, Moscow, 117321

  • 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

  • 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

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

    Moscow, Moscow, 129110

  • Limited Liability Company "Available Polyclinic"

    Murino, Leningradskaya Oblast', 188678

  • Limited Liability Company "Medical Center "Healthy Family"

    Novosibirsk, Novosibirsk Oblast, 630099

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

    Orenburg, Orenburg Oblast, 460018

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

    Ryazan, Ryazan Oblast, 390046

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

    Saint Petersburg, Sankt-Peterburg, 191123

  • Limited Liability Company "International Medical Center"

    Saint Petersburg, Sankt-Peterburg, 191123

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

    Saint Petersburg, Sankt-Peterburg, 192148

  • Limited Liability Company "Health Energy"

    Saint Petersburg, Sankt-Peterburg, 194156

  • Limited Liability Company "Interleukin"

    Saint Petersburg, Sankt-Peterburg, 194214

  • Limited Liability Company "Institute of Medical Research"

    Saint Petersburg, Sankt-Peterburg, 196084

  • Limited Liability Company "Research Center Eco-Safety"

    Saint Petersburg, Sankt-Peterburg, 196143

  • Limited Liability Company "PiterKlinika"

    Saint Petersburg, Sankt-Peterburg, 196158

  • Limited Liability Company "ArsVite North-West"

    Saint Petersburg, Sankt-Peterburg, 196191

  • Limited Liability Company "Curator"

    Saint Petersburg, Sankt-Peterburg, 196240

  • Private medical institution "Euromedservice"

    Saint Petersburg, Sankt-Peterburg, 196603

  • Limited Liability Company "MEDINET"

    Saint Petersburg, Sankt-Peterburg, 197136

  • Limited Liability Company "SB Clinic of Cosmetology"

    Saratov, Saratov Oblast, 410012

  • Regional state budgetary healthcare institution "Smolensk Dermatovenerological Dispensary"

    Smolensk, Smolensk Oblast, 214031

  • State Budgetary Healthcare Institution Ulyanovsk area Clinical Hospital

    Ulyanovsk, Ulyanovsk Oblast, 432063

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

    Yekaterinburg, Ekaterinburg, 620076

Other trials in Russia

About this study

Official title: Multicenter International Single-blind Randomized Comparative Clinical Study of the Efficacy and Safety of GNR-068 (45 mg) and Stelara® (45 mg) and Assessment of the Safety, Tolerability and Long-term Effectiveness of GNR-068 in Patients With Moderate and Severe Forms of Plaque Psoriasis

This is a randomized single-blind comparative parallel group efficacy and safety study of ustekinumab biosimilar GNR-068 (45 mg) and reference product Stelara® (45 mg) in the treatment of patients with moderate and severe forms of plaque psoriasis. Participants received a subcutaneous dose of ustekinumab 45 mg (GNR-068 or Stelara®) at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28 and then all patients receive GNR-068 45 mg. For patients with partially respond to the initial regimen the regimen can be adjusted.

Read the detailed description

The drug GNR-068 (INN: ustekinumab) is being developed as a biosimilar to the drug Stelara®, solution for subcutaneous administration (Silag AG, Switzerland).

Preclinical studies and early phase clinical studies suggest that interleukins-12 (IL-12) and -23 (IL-23), two molecules that are part of the communication network in the immune system, may play an important role in psoriasis. Ustekinumab is a monoclonal antibody directed against IL-12 and IL-23. This is a randomized, single blind, parallel-group, multicenter study to determine the effectiveness and safety of ustekinumab biosimilar GNR-068 administered subcutaneously as compared with Stelara® in patients with moderate to severe plaque-type psoriasis. Patients receive GNR-068 45 mg or Stelara 45 mg administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28, thereafter until week 52 all patients receive GNR-068. For patients who partially respond to the initial regimen, the dose can be adjusted to 90 mg and then the interval can be adjusted to every 8 weeks. The study included a screening period, comparative treatment period, non-comparative treatment period, follow up period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 1:1. 422 patients (211 to each study groups) were randomized.

Being tested
GNR-068, Stelara®
Keywords
ustekinumab, humanized monoclonal antibodies, safety, plaque psoriasis, equivalence, biosimilar, PASI (Psoriasis Area and Severity Index), BSA (Body Surface Area), DLQI (Dermatological Life Quality Index), PGA (Physician's Global Assessment), immunogenicity

What participants receive

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

  • GNR-068Biological

    Also called ustekinumab biosimilar

    GNR-068 was administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 52.

  • Stelara®Biological

    Also called ustekinumab

    Stelara® was administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28 and then all patients receive GNR-068 45 mg until week 52.

Study groups in NCT06488664
Study groupRoleWhat they receive
GNR-068 (JSC "GENERIUM", Russia)ExperimentalTest drug
Receives: Biological: GNR-068
Stelara® (manufacturer Silag AG, Switzerland)Active comparatorreference drug
Receives: Biological: Stelara®

What is being measured

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

  1. The proportion of subjects with Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above

    PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).

    Measured: Week 12

Secondary outcomes (9)

  1. The proportion of patients achieving PASI50/75/90/100

    PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).

    Measured: Week 60

  2. Time to reach PASI50, PASI75, PASI90, PASI100

    PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).

    Measured: Week 60

  3. Area under the curve (AUC) of PASI

    PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).

    Measured: Week 60

  4. The proportion of partial responders (ie, patients achieving ≥50% but <75% improvement in PASI compared to baseline)

    PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).

    Measured: Week 60

  5. Changes in the BSA index

    Using the BSA (Body Surface Area) index, the surface area of the skin affected by psoriasis is assessed. BSA is measured in %. To determine the area of psoriatic skin lesions the "palm" rule is applicable. On the scalp, the affected area the size of one palm is assumed to be 10%, the torso - 3.3%, the upper extremities - 5%, the lower extremities - 2.5% of the area of the anatomical region of the body. To calculate the total BSA, each reported percentage must be multiplied by the corresponding factor of the corresponding body region (head = 0.1, torso = 0.3, upper extremities = 0.2, lower extremities = 0.4). The resulting four percentage values (percentage of skin affected by psoriasis on the scalp, upper extremities, trunk, and lower extremities) will be summed to estimate the BSA index.

    Measured: Week 60

  6. Changes in PGA

    The PGA is 7-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).

    Measured: Week 60

  7. Changes in the intensity of itching on the visual analogue scale (VAS)

    The intensity of itching is carried out at all visits using a visual analogue scale (VAS), where the left end of the line is 0 = no itching, the right end of the line is 10 = intense itching

    Measured: Week 60

  8. Changes in quality of life, assessed using the Dermatology Life Quality Index (DLQI)

    The DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).

    Measured: Week 60

  9. The proportion of patients who dropped out of the study due to lack of sufficient therapeutic response

    Treatment failure is assessed as no effect within 28 weeks (PASI response <50%)

    Measured: Week 60

Timeline

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

  1. First posted5 Jul 2024
  2. Study start25 Jul 2023
  3. Primary completion30 Apr 2025
  4. Study completion26 Nov 2025

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
Single blind
Who is masked
Participant
Enrolment
422 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06488664
Sponsor's protocol ID
UKM-PS-III
Status last verified
Sep 2026
First submitted
28 Jun 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
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 GNR-068 and Stelara® in people with Plaque Psoriasis, run by AO GENERIUM at 34 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 18 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: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The proportion of subjects with Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above (time frame: Week 12). 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 NCT06488664.

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 21 Sep 2026.

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