Idiopathic Thrombocytopenic PurpuraPhase 3NCT05220878

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

A Phase 3 study testing GNR-069 and Nplate in people with Idiopathic Thrombocytopenic Purpura, run by AO GENERIUM at 18 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

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 Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Idiopathic Thrombocytopenic Purpura
What is being tested?: GNR-069 and Nplate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 18 sitesRussia
Study dates: 9 Sep 2021to 19 Oct 2023
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 Form to participate in the study;
Men and women aged 18-75 years inclusive at the time of signing the Informed Consent Form;
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;
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;

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For patients who underwent splenectomy:
loss/lack of response to splenectomy;
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;
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;
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.

Who cannot join

Hypersensitivity to the components of investigational or reference drug or E. coli proteins ;
Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ;
Fisher-Evans Syndrome;
Conditions with a high risk of thromboembolic complications ;
Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis;
Deviations of clinical and laboratory parameters according to the results of studies of blood samples taken during the screening period;

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Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
Pregnancy or breastfeeding;
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;
Splenectomy within 12 weeks prior to screening;
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);
Any other disease or condition that, in the opinion of the investigator, may preclude the patient from participating in the study.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Russia18 sites

State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital
Irkutsk, Irkutsk Oblast, 664079
State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"
Kaluga, Kaluga Oblast, 248007
State Autonomous Healthcare Institution "Kuzbass Clinical Hospital named after S.V. Belyaev"
Kemerovo, Kemerovo Oblast, 650066
State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov" Department of Health of the city of Moscow.
Moscow, 111123
Federal State Budgetary Institution "National Medical Research Center for Hematology" of the Ministry of Health of the Russian Federation
Moscow, 125167
State budgetary health care institution of the city of Moscow "Clinical Hospital named after S.P. Botkin" of the Department of Health of the city of Moscow
Moscow, 125284
State budgetary health care institution of the city of Moscow "City Clinical Hospital named after V.V. Veresaev of the Department of Health of the City of Moscow"
Moscow, 127644
State Budgetary Health Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
Moscow, 129110
State budgetary institution of health care of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126
Llc "Medis"
Nizhny Novgorod, Nizhny Novgorod Oblast, 603137
Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation
Novosibirsk, Novosibirsk Oblast, 630091
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
Rostov-on-Don, Rostov Oblast, 344022
Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation
Saint Petersburg, 197341
Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
Samara, Samara Oblast, 443099
Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation
Saratov, Saratov Oblast, 410012
State Health Institution of the Tula Region "Tula Regional Clinical Hospital"
Tula, Tula Oblast, 300053
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Ufa, Bashkortostan Republic, 450008
Municipal budgetary institution "Central City Hospital No. 7"
Yekaterinburg, 620137

Other trials in Russia

About this study

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

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

Read the 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.

Conditions: Idiopathic Thrombocytopenic Purpura
Being tested: GNR-069, Nplate
Keywords: Idiopathic thrombocytopenic purpura, ITP, Thrombocytopenia, 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
Medical subject headings: Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia, Hemorrhage, Purpura, Ecchymosis

What participants receive

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

GNR-069Biological
Also called romiplostim
Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg.
NplateBiological
Also called romiplostim
Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg.

Study groups in NCT05220878
Study group	Role	What they receive
GNR-069	Experimental	Main group (80 patients) - multiple weekly subcutaneous injections of GNR-069, doses are calculated individually. Receives: Biological: GNR-069
Nplate	Active comparator	Control group (80 patients) - multiple weekly subcutaneous injections of Nplate, doses are calculated individually. Receives: Biological: Nplate

What is being measured

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

Proportion of patients achieving sustained response to treatment
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.
Measured: 26 weeks

Secondary outcomes (7)

Proportion of patients who achieve stable platelet count during treatment with investigational or reference drug
Stable platelet count is defined as the number of platelets ≥ 50.0 x 109/L for at least 4 consecutive weeks without dose adjustment.
Measured: 26 weeks
Time from initiation of therapy with investigational or reference drug to reaching a stable platelet count
Measured: 26 weeks
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
Measured: 25 weeks
Number of clinically significant bleeding episodes during the treatment period, starting from the second week of therapy with investigational or reference drug
Bleeding episode ≥ Grade 2 according to CTCAE version 5.0 is considered clinically significant
Measured: 26 weeks
Change in ITP-specific bleeding assessment tool (ITP-BAT) scores at last visit from baseline at screening
Measured: 26 weeks
Proportion of patients with no/loss of response to treatment with investigational or reference drug
Measured: 26 weeks
Proportion of patients receiving approved ITP prophylactic drugs (glucocorticosteroids, azathioprine, danazol) in this study at the time of randomization
Measured: 26 weeks

Timeline

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

9 Sep 202119 Oct 2023

First posted2 Feb 2022
Study start9 Sep 2021
Primary completion22 Aug 2023
Study completion19 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Model description: Parallel assignment
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05220878
Sponsor's protocol ID: RMP-ITP-III
Other IDs: № 407 eff. date 29 July 2021
Status last verified: Mar 2024
First submitted: 21 Jan 2022
Last updated: 6 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)

All Idiopathic Thrombocytopenic Purpura trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05220878
Acronym / sponsor ID: RMP-ITP-III
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: Idiopathic thrombocytopenic purpura, ITP, Thrombocytopenia, Thrombocytopoiesis, Bleeding, Hemorrhagic syndrome, Petechial rash, Ecchymosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: AO GENERIUMIndustry (pharma, biotech, devices)
Study start: 9 Sep 2021 (actual)
Primary completion: 22 Aug 2023 (actual)
Study completion: 19 Oct 2023 (actual)
First posted: 2 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Parallel assignment

Arm	Type	Receives
GNR-069	Experimental	Biological: GNR-069Main group (80 patients) - multiple weekly subcutaneous injections of GNR-069, doses are calculated individually.
Nplate	Active comparator	Biological: NplateControl group (80 patients) - multiple weekly subcutaneous injections of Nplate, doses are calculated individually.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Written Informed Consent Form to participate in the study;
Men and women aged 18-75 years inclusive at the time of signing the Informed Consent Form;
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;
A. For patients who have not had splenectomy:
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;

Key exclusion criteria (21 listed)

Hypersensitivity to the components of investigational or reference drug or E. coli proteins ;
Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ;
Fisher-Evans Syndrome;
Conditions with a high risk of thromboembolic complications ;
Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GNR-069Also: romiplostimOnce a week as a subcutaneous injection. The initial dose is 1 mcg/kg.	Biological	GNR-069
NplateAlso: romiplostimOnce a week as a subcutaneous injection. The initial dose is 1 mcg/kg.	Biological	Nplate

Primary outcome

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.

7 secondary outcomes

Proportion of patients who achieve stable platelet count during treatment with investigational or reference drug
Time frame: 26 weeks
Time from initiation of therapy with investigational or reference drug to reaching a stable platelet count
Time frame: 26 weeks
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
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
Change in ITP-specific bleeding assessment tool (ITP-BAT) scores at last visit from baseline at screening
Time frame: 26 weeks
Proportion of patients with no/loss of response to treatment with investigational or reference drug
Time frame: 26 weeks
Proportion of patients receiving approved ITP prophylactic drugs (glucocorticosteroids, azathioprine, danazol) in this study at the time of randomization
Time frame: 26 weeks

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
Individual participant dataSharing planned: No

Related trials for Idiopathic Thrombocytopenic Purpura

RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oksana A. Markova, MD, MSc study chair

AO GENERIUM

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GNR-069 and Nplate in people with Idiopathic Thrombocytopenic Purpura, run by AO GENERIUM at 18 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 11 inclusion and 21 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

Proportion of patients achieving sustained response to treatment (time frame: 26 weeks). 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 NCT05220878.

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 6 Mar 2024.