Actively Recruiting
A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Elritercept Alone or With Ruxolitinib in Adults With Myelofibrosis
Led by Takeda · Updated on 2026-02-05
135
Participants Needed
46
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of an investigational drug called elritercept, both alone and in combination with the JAK inhibitor ruxolitinib, in adults with myelofibrosis MF. The study also aims to understand how elritercept affects the signs and symptoms of MF, how the body processes the drug, and its effects on anemia when used with or without ruxolitinib. This is a Phase 2 open-label study focusing on participants with anemia related to MF.
CONDITIONS
Brief Title
A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide signed informed consent
- Willing and able to follow study procedures and attend visits
- Male or female aged 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance score of 2 or less
- Life expectancy of 12 months or longer as assessed by Investigator
- Confirmed diagnosis of primary, post-polycythemia vera, or post-essential thrombocythemia myelofibrosis per specified criteria
- Anemia defined by red blood cell transfusion history or hemoglobin levels as specified
- Arm-specific criteria related to prior JAK inhibitor treatment or current ruxolitinib use
- Agreement to use effective contraception if applicable
You will not qualify if you...
- Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before treatment
- Certain heart conditions including severe heart failure, serious arrhythmias, recent heart attack, or unstable angina
- Body mass index of 40 kg/m² or higher
- Uncontrolled high blood pressure despite treatment
- History of drug or alcohol abuse within last 2 years
- Recent stroke, deep vein thrombosis, or arterial embolism within 6 months
- Major surgery within 28 days before treatment
- Known positive HIV or active hepatitis B or C infection
- Recent or active malignancies other than specified myelofibrosis types
- History of organ transplantation
- Allergic reactions to study drugs
- Certain blood disorders causing anemia
- Recent significant bleeding events
- Recent transfusions unrelated to myelofibrosis
- Prior treatment with similar investigational drugs
- Recent use of certain medications or therapies as specified
- Abnormal laboratory values outside defined limits
- Pregnant or breastfeeding females
- Other conditions that may prevent participation as judged by Investigator or Sponsor
- Study staff and immediate family members involved in the trial
Research Team
T
Takeda Contact
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