Recruiting
Phase 3

Romiplostim & Predniso(lo)ne

Sponsor:

Amgen

Code:

NCT07700238

Conditions

Primary Immune Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Romiplostim

Predniso(lo)ne

Study Details

Brief summary:

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).

Conditions

Primary Immune Thrombocytopenia

Study ID

NCT07700238

Start date

Aug 21, 2026

Status verified date

Sep, 2026

Completion date

Oct 14, 2029

Anticipated

Primary completion date

Sep 14, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Romiplostim + Predniso(lo)ne

Participants will receive romiplostim administered subcutaneously (SC) in combination with predniso(lo)ne administered orally during Part 1 of the study.

Participants who complete Part 1 of the study will enter Part 2 and continue participation for study assessments.

active comparator: Predniso(lo)ne

Participants will receive predniso(lo)ne administered orally during Part 1 of the study.

Participants who complete Part 1 of the study will enter Part 2 and continue participation for study assessments.

Interventions

Romiplostim

Administered subcutaneously.

Predniso(lo)ne

Administered orally.

Primary outcome measure

  • Percentage of Participants With a Durable Platelet Response (DPR) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

MemorialCare Long Beach Medical Center

Recruiting

Long Beach, California, United States, 90806

The Bleeding and Clotting Disorders Institute

Recruiting

Peoria, Illinois, United States, 61614

Hematology Oncology Associates of Fredericksburg

Recruiting

Fredericksburg, Virginia, United States, 22408

More Information

Sponsor

Amgen

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • Adult ITP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Amgen on 2026-09-17.