A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis
Condition(s) studied
Investigational drug(s) / intervention(s)
Elritercept: Elritercept SC injection.
Ruxolitinib: Ruxolitinib tablet.
Study summary
The main aim of this study is to learn how safe elritercept is and how well it is tolerated when taken alone and in combination with the JAK inhibitor, ruxolitinib. Other aims are to learn about the effects of elritercept on the signs and symptoms of MF when taken with or without ruxolitinib and to learn how elritercept affects the body, how the body processes elritercept, and the effects of elritercept on anemia when taken with or without ruxolitinib The study will also check on how safe elritercept is and how well it is tolerated.
Eligibility
Primary outcome measure(s)
- Part 1: Number of Participants with Adverse Events (AEs), Dose Limiting Toxicities (DLTs), Severe Adverse Events (AEs) and Serious Adverse Events (SAEs) — From signing of the informed consent form (ICF) through 30 days after the last dose of study drug (approximately 8 years)
AE:any untoward medical occurrence (MO) in clinical study participant administered medicinal product not necessarily having causal relationship with treatment.Severe AE medically significant AE but not immediately life-threatening;may result in hospitalization/ prolonged hospital stay;disability.SAE:any untoward MO that,at any dose results in death,is life-threatening,requires in-patient hospitalization/ prolongation of existing hospitalization,results in persistent or significant disability/incapacity,is congenital anomaly/birth defect,is medically important event.DLT: any following safety events-death,Grade 4 neutropenia/ thrombocytopenia \>7 days,Grade 3 thrombocytopenia with bleeding,Neutropenic fever,assessments meeting Hy's law,Grade ≥3 nonhematologic treatment-emergent adverse events(TEAEs),elevated hemoglobin(Hgb)/ platelet count requiring dose modification, other safety event considered by Safety Review Committee(SRC) to be significant to warrant categorization as DLT. - Part 2 and Long-Term Extension: Number of Participants with Adverse Events (AEs), Severe AEs and SAEs — From signing of the ICF through 30 days after the last dose of study drug, (approximately 8 years)
An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. Severe AE is defined as an AE which is medically significant but not immediately life-threatening; may result in hospitalization or prolonged hospital stay; disabling. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| Concord Hospital | Concord | New South Wales | Recruiting |
| The Tweed Hospital | Tweed Heads | New South Wales | Recruiting |
| Flinders Medical Centre | Woodville South | South Australia | Recruiting |
| St. Vincents Hospital Melbourne | Fitzroy | Victoria | Recruiting |
| Royal Melbourne Hospital | Melbourne | Victoria | Recruiting |
| Ballarat Oncology & Haematology Service | Wendouree | Victoria | Recruiting |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Brazil | Recruiting |
| IMV-Pesquisa Cardiologica Sociedade Simples | Porto Alegre | Brazil | Recruiting |
| Albert Einstein Sociedade Beneficente Israelita Brasiliera | São Paulo | Brazil | Recruiting |
| Hospital Beneficencia Portuguesa de Sao Paulo | São Paulo | Brazil | Recruiting |
| Hospital Das Clinicas Da Faculdade de Medicina Da U S P | São Paulo | Brazil | Recruiting |
| Instituto de Ensino e Pesquisas Sao Lucas | São Paulo | Brazil | Recruiting |
| CHU Amiens - Hopital Sud | Amiens | France | Completed |
| Hopital Morvan | Brest | France | Completed |
| Hopital Prive Sevigne | Cesson-Sévigné | France | Completed |
| Centre Hospitalier Lyon Sud | Lyon | France | Recruiting |
| Institut de Cancerologie du Gard | Nîmes | France | Recruiting |
| Hopital de la Source - CHR Orleans | Orléans | France | Completed |
| Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Bari | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi | Bologna | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Brescia | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Careggi | Florence | Italy | Recruiting |
| Ospedale Policlinico San Martino | Genova | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda, Niguarda Cancer Center | Milan | Italy | Recruiting |
| Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Milan | Italy | Completed |
| Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia | Reggio Emilia | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Umberto I | Roma | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Sette Laghi | Varese | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy | Recruiting |
| Gachon University Gil Medical Center | Incheon | South Korea | Completed |
| Samsung Medical Center | Seoul | South Korea | Completed |
| Seoul St. Marys Hospital, The Catholic University of Korea | Seoul | South Korea | Recruiting |
| Soonchunhyang University Seoul Hospital | Seoul | South Korea | Recruiting |
| ICO Badalona - Hospital Universitari Germans Trias i Pujol | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Hospital Universitario La Princesa | Madrid | Spain | Recruiting |
| Hospital Universitario de Salamanca | Salamanca | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Recruiting |
+ 6 more sites — see the full list on the official registry below.
On this site
📄 Jakafi (ruxolitinib) drug profile →More Takeda trials in Australia
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05037760 on ClinicalTrials.gov ↗ ← All trials in Australia