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Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05220878
Recruitment Status : Recruiting
First Posted : February 2, 2022
Last Update Posted : February 23, 2023
Sponsor:
Information provided by (Responsible Party):
AO GENERIUM

Study Description
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Brief Summary:
It is a phase III multicenter randomized double-blinded comparative study of clinical efficacy and safety of GNR-069 and Nplate in patients with idiopathic thrombocytopenic purpura

Condition or disease Intervention/treatment Phase
Idiopathic Thrombocytopenic Purpura Biological: GNR-069 Biological: Nplate Phase 3

Detailed Description:
The drug GNR-069(JSC "GENERIUM", Russia) is biosimilar to the original drug Nplate. This study is aimed to compare the clinical efficacy and safety of the drug GNR-069 and the drug Nplate to register of the drug GNR-069 in the Russian Federation for therapy in patients with idiopathic thrombocytopenic purpura (ITP). The study also provides for the evaluation of pharmacokinetic parameters and immunogenicity.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blinded
Primary Purpose: Treatment
Official Title: Multicenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC "GENERIUM", Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Idiopathic Thrombocytopenic Purpura
Actual Study Start Date : September 9, 2021
Estimated Primary Completion Date : November 10, 2023
Estimated Study Completion Date : January 15, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Romiplostim

Arms and Interventions
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Arm Intervention/treatment
Experimental: GNR-069
Main group (80 patients) - multiple weekly subcutaneous injections of GNR-069, doses are calculated individually.
 Biological: GNR-069
Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg.
Other Name: romiplostim
Active Comparator: Nplate
Control group (80 patients) - multiple weekly subcutaneous injections of Nplate, doses are calculated individually.
 Biological: Nplate
Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg.
Other Name: romiplostim


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients achieving sustained response to treatment [ Time Frame: 26 weeks ]
    A sustained response to treatment is defined as the number of platelets ≥ 50.0 x 109/L for at least 9 out of 12 consecutive visits during the treatment period with the study or reference drug.


Secondary Outcome Measures :
  1. Proportion of patients who achieve stable platelet count during treatment with investigational or reference drug [ Time Frame: 26 weeks ]
    Stable platelet count is defined as the number of platelets ≥ 50.0 x 109/L for at least 4 consecutive weeks without dose adjustment.

  2. Time from initiation of therapy with investigational or reference drug to reaching a stable platelet count [ Time Frame: 26 weeks ]
  3. Number of cases of emergency therapy for severe hemorrhagic syndrome during the treatment period, starting from the second week of therapy with the investigational or reference drug [ Time Frame: 25 weeks ]
  4. Number of clinically significant bleeding episodes during the treatment period, starting from the second week of therapy with investigational or reference drug [ Time Frame: 26 weeks ]
    Bleeding episode ≥ Grade 2 according to CTCAE version 5.0 is considered clinically significant

  5. Change in ITP-specific bleeding assessment tool (ITP-BAT) scores at last visit from baseline at screening [ Time Frame: 26 weeks ]
  6. Proportion of patients with no/loss of response to treatment with investigational or reference drug [ Time Frame: 26 weeks ]
  7. Proportion of patients receiving approved ITP prophylactic drugs (glucocorticosteroids, azathioprine, danazol) in this study at the time of randomization [ Time Frame: 26 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written Informed Consent Form to participate in the study;
  2. Men and women aged 18-75 years inclusive at the time of signing the Informed Consent Form;
  3. Documented diagnosis of ITP with a disease duration of more than 12 months from the moment of confirmation of the diagnosis by bone marrow aspirate or biopsy results;

  4. A. For patients who have not had splenectomy:

    • established absence/loss of response to therapy with at least one drug of fist-line treatment for ITP (which include GCs an IVIG); OR
    • the occurrence of side effects during the course of therapy with the drug of the fist-line, making it impossible to use it further;

    B. For patients who underwent splenectomy:

    • loss/lack of response to splenectomy;

  5. Thrombocytopenia ≥30.0 x 109/L - <50.0 x 109/L with severe hemorrhagic syndrome or thrombocytopenia <30.0 x 109/l, regardless of the presence of hemorrhagic syndrome, according to the results of platelet count conducted in a local laboratory for 7 days before the start of therapy with investigational or reference drug;
  6. Patients receiving GCs, azathioprine and danazole should receive these drugs in a maintenance dose for at least 4 weeks before starting therapy with investigational or reference drug;
  7. Consent of study participants with preserved childbearing function to use reliable methods of contraception (a combination of at least two methods, including 1 barrier method, for example, the use of a condom and spermicide) from the moment of signing the Informed Consent Form and 3 months after the last administration of investigational or reference drug.

Exclusion Criteria:

  1. Hypersensitivity to the components of investigational or reference drug or E. coli proteins ;
  2. Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ;
  3. Fisher-Evans Syndrome;
  4. Conditions with a high risk of thromboembolic complications ;
  5. Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis;
  6. Deviations of clinical and laboratory parameters according to the results of studies of blood samples taken during the screening period;
  7. Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
  8. Pregnancy or breastfeeding;

  9. Use of drugs:

    • romiplostim used less than 3 weeks before treatment with study or reference drug;
    • IVIG - less than 2 weeks prior to initiation of study or reference drug therapy;
    • eltrombopag - used less than 2 weeks before treatment with study or reference drug, or planned to use eltrombopag while the patient is participating in this study;
    • rituximab - used less than 14 weeks before treatment with study or reference drug, or planned to use rituximab while the patient is enrolled in this study;
    • cyclophosphamide, cyclosporine, vincristine, vinblastine and other drugs used to treat ITP not listed above and not included in the list of drugs approved for use during the study - use less than 8 weeks before the start of therapy with the study or reference drug or the use of any of these drugs is planned during the patient's participation in this study;
    • preparations of any hematopoietic growth factors - use less than 8 weeks before the start of therapy with an investigational or reference drug;
    • Influenza vaccines - less than 21 days prior to start of treatment with study or reference drug;
    • vaccines to prevent novel coronavirus disease (COVID-19) - completion of the vaccination program less than 21 days prior to the start of study or reference drug therapy;
    • other vaccines - less than 8 weeks prior to start of treatment with study or reference drug;
  10. Splenectomy within 12 weeks prior to screening;
  11. Participation in any clinical trials and/or use of unregistered drugs within 4 weeks prior to screening or 5 drug half-lives (whichever is greater);
  12. Any other disease or condition that, in the opinion of the investigator, may preclude the patient from participating in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05220878


Contacts
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Contact: Rusava O. Matyushina, MD, PhD +79150880405 romatyushina@generium.ru
Contact: Oksana A. Markova, MD +79854418959 oamarkova@generium.ru

Locations
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Sponsors and Collaborators
AO GENERIUM
Investigators
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Study Chair: Oksana A. Markova, MD, MSc AO GENERIUM
More Information
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Responsible Party: AO GENERIUM
ClinicalTrials.gov Identifier: NCT05220878    
Other Study ID Numbers: RMP-ITP-III
№ 407 eff. date 29 July 2021 ( Other Identifier: Ministry of Health of the Russian Federation )
First Posted: February 2, 2022    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AO GENERIUM:
Idiopathic thrombocytopenic purpura
Thrombocytopenia
ITP
Thrombocytopoiesis
Bleeding
Hemorrhagic syndrome
Petechial rash
Ecchymosis
Fc-peptide
Recombinant DNA technology
Thrombopoietin receptors
Platelet formation
Fc fragment of human immunoglobulin IgG 1
Low platelet count
 ITP treatment
Platelets
Haemorrhage
Platelet destruction
Impaired thrombopoiesis
Megakaryocytes
Autoantibodies
Splenectomy
Cytotoxic
T cells
Thrombopoietin receptor agonists
TPO-RAs
romiplostim
Nplate
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
 Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Blood Platelet Disorders
Hemorrhagic Disorders
Autoimmune Diseases