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A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib

NCT07623161 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2026-08-05

No results posted yet for this study

Summary

The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.

Other aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.

The study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.

Conditions

Interventions

DRUG

Placebo

Elritercept-matching placebo

DRUG

Elritercept

Elritercept, SC, injection

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-25
Primary Completion
2029-12-07
Completion
2034-03-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Poland
  • Romania
  • Saudi Arabia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623161 on ClinicalTrials.gov