Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia

NCT06497036 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: GP40141-P4-03-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are

1. 1.Assess the effectiveness of GP40141 in comparison with Nplate®.
2. 2.Assess the immunogenicity of GP40141 in comparison with the drug Nplate®.
3. 3.Assess the safety of GP40141 in comparison with the drug Nplate®.
4. 4.Assess the safety of changing romiplostim and eltrombopag to GP40141.
5. 5.Assess the pharmacokinetic parameters of the study drugs in patients with primary immune thrombocytopenia.

Conditions

Drug Effect; Safety Issues; Immunogenicity

Keywords

romiplostim, nplate, bioequivalence

Outcome Measures

Primary Outcomes (5)

• Proportion of subjects with platelet response

  Blood platelet count ≥50×10\*9/L after 10 weeks of therapy (at Visit 11), or blood platelet count ≥200×10\*9/L at the last assessment if the study was terminated early.

  10 weeks

• Number of adverse events (AEs)

  AEs including ones of special interest: bleeding, thrombotic and thromboembolic events.

  10 weeks

• Proportion of subjects experiencing AEs,

  AEs including ones of special interest: bleeding, thrombotic and thromboembolic events.

  10 weeks

• Proportion subjects with a immune response to romiplostim

  Proportion of initially immunonaive subjects with a documented immune response to romiplostim at Visits 8 and 26 (weeks 8 and 26).

  26 weeks

• Proportion subjects with a immune response to endogenous thrombopoietin

  Proportion of initially immunonaive subjects with a documented immune response to endogenous thrombopoietin at Visits 8 and 26 (weeks 8 and 26).

  26 weeks

Study Arms (2)

GP40141

EXPERIMENTAL

Lyophilized powder for solution 250 mcg in vials is diluted in sterile water for injection to a concentration of 500 mcg/ml. Administer once a week. Cohort 1 Starting dose of romiplostim is 1 mcg/kg actual body weight. The weekly dose of romiplostim is increased in increments of 1 mcg/kg body weight until the patient's platelet count reaches ≥50 x 10\*9/L. Platelet counts are assessed weekly. Cohort 2 * For subjects receiving Nplate®, a switch to GP40141 at an equivalent dose is recommended 7±2 days after the last Nplate® administration. The transition is equidosal since the drugs contain the same active ingredient. * For patients receiving eltrombopag or Etrombopag-29F® (Pharmproekt, Russia)), it is recommended to switch to GP40141 at an initial dose of 1 mcg/kg the day after the last dose of eltrombopag. The maintenance dose, dose adjustment, and maximum dose are consistent for both cohorts. Duration of therapy with study drugs will be 26 weeks.

Drug: GP404141

Nplate

ACTIVE COMPARATOR

Lyophilized powder for solution 250 mcg in vials is diluted in sterile water for injection to a concentration of 500 mcg/ml. Administer once a week. Cohort 1 Starting dose of romiplostim is 1 mcg/kg actual body weight. The weekly dose of romiplostim is increased in increments of 1 mcg/kg body weight until the patient's platelet count reaches ≥50 x 10\*9/L. Platelet counts are assessed weekly. Cohort 2 Initial dose: • For patients receiving eltrombopag or Etrombopag-29F® (Pharmproekt, Russia)), it is recommended to switch to at Nplate® initial dose of 1 mcg/kg the day after the last dose of eltrombopag. The maintenance dose, dose adjustment, and maximum dose are consistent for both cohorts. Duration of therapy with study drugs will be 26 weeks.

Drug: Nplate

Interventions

GP404141 DRUG

subcutaneous injection

Also known as: romiplostim

GP40141

Nplate DRUG

subcutaneous injection

Also known as: romilostim

Nplate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent to participate in the study.
• male or female
• Age ≥18 years
• Diagnosis of primary immune thrombocytopenia (PIT).
• Duration of PIT at the Screening Visit: for cohort 1: ≥3 months; for cohort 2: ≥6 months.
• PIT therapy with glucocorticosteroids (GCS) for cohort 1: duration of continuous therapy ≥3 months at the Screening Visit or ≥2 courses of pulse therapy during the year before the Screening Visit;
• TPO-RA therapy: for cohort 1: no history of TPO-RA use; for Cohort 2: Use of TPO-RA for ≥12 weeks at the Screening Visit;
• No increase in TPO-RA dose during the 4 weeks preceding the end of screening.
• Blood platelet count: for cohort 1: mean platelet count ≤30×10\*9/L, based on the last two measurements 7±2 days apart, each of which had a platelet count ≤35×10\*9/L OR steroid dependence, defined as the use of prednisolone at a daily dose of \>5 mg (or another corticosteroid at an equivalent dose) for ≥2 months before the Screening Visit to maintain a platelet count ≥30×10\*9/L OR to prevent bleeding; for cohort 2: platelet count ≥50×10\*9/ml for ≥6 weeks out of the last 8 weeks of follow-up with platelet counts every 7±2 days and no emergency treatment for severe hemorrhagic syndrome in the last 12 weeks before the Screening Visit.
• Consent and ability to comply with the procedures of the Protocol, as well as the prohibitions and restrictions provided for by the Research Protocol.

You may not qualify if:

• Hypersensitivity to romiplostim.
• History of TPO-RA use: for cohort 1: any TPO-RA; for cohort 2: any TPO-RA, with the exception of romiplostim and eltrombopag.
• Unpromising treatment with romiplostim in the opinion of the Researcher
• Splenectomy \<24 weeks prior to the Screening Visit or planned splenectomy during the study.
• Treatment with rituximab within the 14 weeks preceding the Screening Visit, or planned treatment with rituximab during the study.
• Treatment with intravenous immunoglobulin or anti-D immunoglobulin during the 2 weeks preceding the Screening Visit, or planned use during the study.
• Therapy with hematopoietic growth factors during the 4 weeks preceding the Screening Visit, or their planned use during the study.
• Therapy with alkylating chemotherapy drugs during the 8 weeks preceding the Screening Visit, or their planned use during the study.
• Use of other medicines listed in section 5.3.3. of this study protocol.
• Participation in a clinical trial of an investigational drug or investigational medical device within 4 weeks or 5 half-lives (whichever is longer) preceding the Screening Visit.
• Secondary immune thrombocytopenia in the following diseases: autoimmune thyroiditis, systemic lupus erythematosus (SLE), antiphospholipid syndrome (APLS), lymphoproliferative diseases, drug-mediated, viral origin (herpes viruses, HIV, chronic viral hepatitis).
• Hereditary thrombocytopenia.
• Diseases of the hematopoietic system accompanied by thrombocytopenia (for example, acute leukemia, aplastic anemia, myelodysplastic syndrome, lymphoproliferative diseases).
• Metastatic bone marrow lesions.
• Uncontrolled concomitant diseases of internal organs.

Sponsors & Collaborators

• Geropharm: lead
• Pharm-Holding: collaborator
• I.M. Sechenov First Moscow State Medical University: collaborator

Study Sites (6)

Kaluga Regional Clinical Hospital

Kaluga, 248007, Russia

Location

City Clinical Hospital S.P. Botkin of the Moscow City Health Department

Moscow, 125284, Russia

Location

National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation

Saint Petersburg, 194156, Russia

Location

Samara State Medical University" of the Ministry of Health of the Russian Federation

Samara, 443099, Russia

Location

Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

Sochi, 354057, Russia

Location

Federal State Budgetary Educational Institution Bashkir State Medical University of the Ministry of Health of the Russian Federation

Ufa, 450008, Russia

Location

Related Publications (1)

• Melikyan AL, Protsenko EA, Salogub GN, Bakirov BA, Davydkin IL, Kovalik VV, Gefen ML, Matvienko YD, Saparova VB, Khokhlov AL, Makarenko IE, Drai RV. Multicenter Single-Blind Randomized Controlled Trial of the Romiplostim Biosimilar. EJHaem. 2025 Jul 24;6(4):e70105. doi: 10.1002/jha2.70105. eCollection 2025 Aug.

  PMID: 40708707 DERIVED

MeSH Terms

Interventions

romiplostim

Study Officials

• Bulat Bakirov, MD

  Bashkir State Medical University of the Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

• Elena Borisenkova

  Kaluga Regional Clinical Hospital

  PRINCIPAL INVESTIGATOR

• Olga Vinogradova

  City Clinical Hospital named after S.P. Botkin of the Moscow City Health Department

  PRINCIPAL INVESTIGATOR

• Igor Davydkin

  Samara State Medical University of the Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

• Dmitry Kirtbaya

  Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

  PRINCIPAL INVESTIGATOR

• Galina Salogub

  National Medical Research Center VA Almazov Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients will not have access to the treatment assignment code and, therefore, will not know which study drug they are receiving
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, single-blind, randomized controlled trial of efficacy and safety in two parallel groups

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: April 4, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 11, 2024

Record last verified: 2023-10

Locations

RU (6)