Romiplostim plus prednisone vs prednisone alone in adults with newly diagnosed ITP
Official title: A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP).
Run by Amgen · NCT07700238 · Data updated 2026-11-12
This phase 3 trial tests whether adding romiplostim to prednisone helps adults with newly diagnosed primary ITP respond better than prednisone alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Amgen Industry-sponsored |
| Locations | 3 sites (Long Beach, California and 2 other locations) |
| Status | Recruiting |
| Started | August 21, 2026 |
| Main results expected | September 14, 2029 |
| Study ends | October 14, 2029 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT07700238 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with newly diagnosed primary ITP and platelets below 30 or below 50 with significant bleeding, not yet treated before.
✕Probably not a fit
Patients with life-threatening bleeding at randomization or those with contraindications to prednisone or romiplostim may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with primary ITP who have not yet been treated will be randomized to receive romiplostim in addition to prednisone or prednisone alone. The study aims to measure treatment response and safety over time, using standard platelet thresholds to guide treatment decisions. Exclusion criteria include life-threatening bleeding at randomization and prior emergency use of TPO-RAs or splenectomy. Enrollment requires a confirmed diagnosis of primary ITP by excluding other causes and a low platelet count with bleeding risk. The trial is sponsored by Amgen and conducted at a few selected U.S. centers.
Why it matters
Potential benefit: If successful, the combination could improve platelet restoration and reduce bleeding risk in newly diagnosed adult ITP patients.
How similar studies have gone: Prior studies in ITP have explored TPO-RAs with steroids, showing potential benefit, though this specific combination in untreated adults is being evaluated.
Who can join: the full rules
Show full inclusion / 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. * 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. * Note: If emergency treatment is necessary, platelet count performed before emergency can be used for study inclusion. * 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.
Where it's running
-
MemorialCare Long Beach Medical Center
Long Beach, California, United States Recruiting -
The Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States Recruiting -
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States Recruiting
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.