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中等度から重度の尋常性乾癬患者の治療におけるGNR-068（ウステキヌマブバイオシミラー）とStelara®の有効性と安全性に関する研究

2026年9月16日 更新者：AO GENERIUM

GNR-068 (45 mg) と Stelara® (45 mg) の有効性と安全性に関する多施設国際単一盲検ランダム化比較臨床研究、および中等度および中等症患者における GNR-068 の安全性、忍容性、および長期有効性の評価重篤な尋常性乾癬

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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

422

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • ロシア
    • Barnaul
      • Barnaul、Barnaul、ロシア、656038
        • Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University" of the Ministry of Health of the Russian Federation
    • Chelyabinsk Oblast
      • Chelyabinsk、Chelyabinsk Oblast、ロシア、454048
        • State budgetary healthcare institution "Chelyabinsk Regional Clinical Dermatovenerological Dispensary"
      • Chelyabinsk、Chelyabinsk Oblast、ロシア、454126
        • Limited Liability Company "Ecology of Health"
    • Ekaterinburg
      • Yekaterinburg、Ekaterinburg、ロシア、620076
        • State budgetary institution of the Sverdlovsk region "Ural Research Institute of Dermatovenereology and Immunopathology"
    • Izhevsk
      • Izhevsk、Izhevsk、ロシア、426061
        • Limited Liability Company "Alliance Biomedical - Ural Group"
    • Kirov Oblast
      • Kirov、Kirov Oblast、ロシア、610027
        • 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))
    • Leningradskaya Oblast'
      • Murino、Leningradskaya Oblast'、ロシア、188678
        • Limited Liability Company "Available Polyclinic"
    • Lipetsk Oblast
      • Lipetsk、Lipetsk Oblast、ロシア、398005
        • State health care institution "Regional Dermatovenerological Dispensary"
    • Moscow
      • Moscow、Moscow、ロシア、105554
        • Limited Liability Company "OLLA-MED"
      • Moscow、Moscow、ロシア、115522
        • Federal State Budgetary Institution "Research Institute of Rheumatology named after V.A. Nasonova"
      • Moscow、Moscow、ロシア、117321
        • Limited Liability Company "Firma ORIS"
      • Moscow、Moscow、ロシア、119071
        • 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、ロシア、127006
        • 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、ロシア、129110
        • State budgetary healthcare institution of the Moscow region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
    • Moscow Oblast
      • Korolyov、Moscow Oblast、ロシア、141060
        • Limited Liability Company "Family Clinic No. 4"
    • Novosibirsk Oblast
      • Novosibirsk、Novosibirsk Oblast、ロシア、630099
        • Limited Liability Company "Medical Center "Healthy Family"
    • Orenburg Oblast
      • Orenburg、Orenburg Oblast、ロシア、460018
        • Federal State Budgetary Educational Institution of Higher Education Orenburg State Medical University of the Ministry of Health of Russia
    • Ryazan Oblast
      • Ryazan、Ryazan Oblast、ロシア、390046
        • State budgetary institution of the Ryazan region "Regional clinical dermatovenerological dispensary"
    • Sankt-Peterburg
      • Saint Petersburg、Sankt-Peterburg、ロシア、191123
        • Limited Liability Company "Clinic of Skin Diseases Pierre Wolkenstein"
      • Saint Petersburg、Sankt-Peterburg、ロシア、191123
        • Limited Liability Company "International Medical Center"
      • Saint Petersburg、Sankt-Peterburg、ロシア、192148
        • Limited Liability Company "Medical Technologies" LLC "Medical Technologies"
      • Saint Petersburg、Sankt-Peterburg、ロシア、194156
        • Limited Liability Company "Health Energy"
      • Saint Petersburg、Sankt-Peterburg、ロシア、194214
        • Limited Liability Company "Interleukin"
      • Saint Petersburg、Sankt-Peterburg、ロシア、196084
        • Limited Liability Company "Institute of Medical Research"
      • Saint Petersburg、Sankt-Peterburg、ロシア、196143
        • Limited Liability Company "Research Center Eco-Safety"
      • Saint Petersburg、Sankt-Peterburg、ロシア、196158
        • Limited Liability Company "PiterKlinika"
      • Saint Petersburg、Sankt-Peterburg、ロシア、196191
        • Limited Liability Company "ArsVite North-West"
      • Saint Petersburg、Sankt-Peterburg、ロシア、196240
        • Limited Liability Company "Curator"
      • Saint Petersburg、Sankt-Peterburg、ロシア、196603
        • Private medical institution "Euromedservice"
      • Saint Petersburg、Sankt-Peterburg、ロシア、197136
        • Limited Liability Company "MEDINET"
    • Saratov Oblast
      • Saratov、Saratov Oblast、ロシア、410012
        • Limited Liability Company "SB Clinic of Cosmetology"
    • Smolensk Oblast
      • Smolensk、Smolensk Oblast、ロシア、214031
        • Regional state budgetary healthcare institution "Smolensk Dermatovenerological Dispensary"
    • Tatarstan Republic
      • Kazan'、Tatarstan Republic、ロシア、420111
        • Limited Liability Company Medical Center "Azbuka Health"
    • Ulyanovsk Oblast
      • Ulyanovsk、Ulyanovsk Oblast、ロシア、432063
        • State Budgetary Healthcare Institution Ulyanovsk area Clinical Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：GNR-068 (JSC "GENERIUM", Russia)

Test drug
生物学的：GNR-068

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

他の名前：
  • ウステキヌマブバイオシミラー
アクティブコンパレータ：Stelara® (manufacturer Silag AG, Switzerland)

reference drug
生物学的：Stelara®

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.

他の名前：
  • ウステキヌマブ

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
The proportion of subjects with Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above
時間枠：Week 12

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).
Week 12

二次結果の測定

結果測定
メジャーの説明
時間枠
The proportion of patients achieving PASI50/75/90/100
時間枠：Week 60

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).
Week 60
Time to reach PASI50, PASI75, PASI90, PASI100
時間枠：Week 60

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).
Week 60
Area under the curve (AUC) of PASI
時間枠：Week 60

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).
Week 60
The proportion of partial responders (ie, patients achieving ≥50% but <75% improvement in PASI compared to baseline)
時間枠：Week 60

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).
Week 60
Changes in the BSA index
時間枠：Week 60

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.
Week 60
Changes in PGA
時間枠：Week 60

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).
Week 60
Changes in the intensity of itching on the visual analogue scale (VAS)
時間枠：Week 60

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
Week 60
Changes in quality of life, assessed using the Dermatology Life Quality Index (DLQI)
時間枠：Week 60

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).
Week 60
The proportion of patients who dropped out of the study due to lack of sufficient therapeutic response
時間枠：Week 60

Treatment failure is assessed as no effect within 28 weeks (PASI response <50%)
Week 60

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AO GENERIUM

捜査官

  • スタディチェア：Oksana A. Markova, MD、JSC GENERIUM

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年7月25日

一次修了 (実際)

2025年4月30日

研究の完了 (実際)

2025年11月26日

試験登録日

最初に提出

2024年6月28日

QC基準を満たした最初の提出物

2024年7月3日

最初の投稿 (実際)

2024年7月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月21日

QC基準を満たした最後の更新が送信されました

2026年9月16日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • UKM-PS-III

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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