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Will Be Recruiting
Sponsor ID
20250124

A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)ROMISTER

Sponsor ID
20250124
Clinicaltrials.gov ID
NCT07700238
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).

Additional Study Details

Phase
Phase 3
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
126
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage of Participants With a Durable Platelet Response (DPR)

Timeframe: 8 weeks

Secondary Outcome Measures

Time to Next Treatment (TTNT)

Timeframe: 12 months

Cumulative Exposure to Corticosteroids

Timeframe: 12 months

Change From Baseline in ITP Patient Assessment Questionnaire (ITP-PAQ)

Timeframe: 12 months

Change in Summary Scores and Visual Analogue Scale (VAS) Scores per EuroQol 5-Dimension 5-Level (EQ 5D-5L)

Timeframe: 12 months

Incidence of Hospitalization and Rescue Medication in Part 1

Timeframe: 6 months

Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Interest (EOI), and Fatal TEAEs

Timeframe: 12 months

Percentage of Participants With Clinically Significant Bleeding Events in the Immune Thrombocytopenia-specific Bleeding Assessment Tool (ITP-BAT)

Timeframe: 6 months

Serum Trough Concentration (Ctrough) of Romiplostim

Timeframe: 6 months

Number of Participants With Anti-Romiplostim Antibodies and Anti-Thrombopoietin (TPO) Antibodies

Timeframe: 6 months

Locations

No locations found.
Study Info
Age
18 - 100 Years
Condition
  • Immune Thrombocytopenia (ITP)
    • Sex
    All
    Trial Dates
    Jul 2026 - Sep 2029
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Age ≥18 years or adult legal age within country if older than 18 years. - Diagnosis of primary ITP according to the 2019 International Consensus (ICR) that is previously untreated and requires treatment. o Note: The investigator should ensure that the diagnosis of primary ITP is established by excluding other causes of isolated thrombocytopenia, as outlined in the 2019 ICR, which states that the diagnosis of primary ITP is principally based on the exclusion of other causes of isolated thrombocytopenia. o Note: If emergency treatment is necessary, platelet count performed before emergency can be used for study inclusion. o Note: Emergency ITP treatment with any thrombopoietin receptor agonists (TPO-RAs), or splenectomy is not allowed. - Platelet count < 30 × 10^9/L or Platelet count < 50× 10^9/L with clinically significant bleeding before any medical intervention.
    Exclusion Criteria:
    - Life-threatening bleeding at randomization. - Known sensitivity or intolerance to any of the products to be administered during study (eg, uncontrolled diabetes) or to any Escherichia coli-derived product (eg, filgrastim, pegfilgrastim, certain insulins). - Uncontrolled hypertension before randomization. - Abnormal hepatic or renal function at screening. - History of total splenectomy. - Use of concurrent anticoagulation therapy and/or antiplatelet therapy. - Need for nonsteroidal anti-inflammatory drugs (NSAIDs) use and use of NSAIDs within 7 days before randomization. - Venous or arterial thrombotic event within 3 or 6 months, respectively, before randomization. - Other protocol-defined Inclusion/Exclusion may apply.