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

NCT07700238 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 20250124
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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

Keywords

Adult ITP

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Durable Platelet Response (DPR)

  8 weeks

Secondary Outcomes (9)

• Time to Next Treatment (TTNT)

  12 months

• Cumulative Exposure to Corticosteroids

  12 months

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

  12 months

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

  12 months

• Incidence of Hospitalization and Rescue Medication in Part 1

  6 months

Study Arms (2)

Romiplostim + Predniso(lo)ne

EXPERIMENTAL

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.

Drug: Romiplostim; Drug: Predniso(lo)ne

Predniso(lo)ne

ACTIVE COMPARATOR

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.

Drug: Predniso(lo)ne

Interventions

Romiplostim DRUG

Administered subcutaneously.

Also known as: AMG 531, Nplate®

Romiplostim + Predniso(lo)ne

Predniso(lo)ne DRUG

Administered orally.

Predniso(lo)ne; Romiplostim + Predniso(lo)ne

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): September 14, 2029
• Study Completion (Estimated): September 14, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.