A Phase 3 interventional study of GNR-068 and Stelara® in Plaque Psoriasis, sponsored by AO GENERIUM. Completed at 34 sites in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by AO GENERIUM · Phase 3, Interventional, and Treatment
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Among 16 studies in Psoriasis with a site in Russia — none open to participants now, 4 under way, 1 of them phase 3. Psoriasis · Russia.
Among the 16 studies in Psoriasis with a site in Russia, this one is the 7th largest by enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2023, is one of 9 in phase 3, and was the 14th registered.
2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.
Browse Psoriasis studies →None of the 16 studies in Psoriasis with a site in Russia is open now. The open studies under Psoriasis, anywhere →
Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 422 is above the median of 75 across 1,567 interventional studies indexed under Psoriasis.
Median enrollment 291 across the 14 interventional studies, 167 across the 2 observational. Of the 12 that completed or were terminated, 8 (67%) have results posted.
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16 of 16 have an industry lead sponsor. The 10 most frequent:
AO GENERIUM is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
AO GENERIUM has 1 study filed under Psoriasis — fewer than ten, so there is no comparison to draw.
2 of the studies in Psoriasis with a site in Russia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06142357Novartis PharmaceuticalsSecukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis | 2027-08-31 |
| NCT03886246LEO PharmaEffisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study | 2027-09-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies in Psoriasis with a site in Russia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients diagnosed with plaque psoriasis at least 6 months before screening:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Test drug
Biological: GNR-068
reference drug
Biological: Stelara®
GNR-068 was administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 52.
Also known as: ustekinumab biosimilar
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.
Also known as: ustekinumab
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).
Time frame: Week 12
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).
Time frame: Week 60
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).
Time frame: Week 60
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).
Time frame: Week 60
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).
Time frame: Week 60
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.
Time frame: Week 60
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).
Time frame: Week 60
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
Time frame: Week 60
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).
Time frame: Week 60
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%)
Time frame: Week 60
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2023 to primary completion in Apr 2025, 21 months.
Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 21 months is above that.
Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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