Phase 1b/2 TL-895 + Ruxolitinib Study in JAKi Treatment-Naïve/ Low Ruxolitinib Response MF Subjects
Research type
Research Study
Full title
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined with Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects with MF who have a Suboptimal Response to Ruxolitinib
IRAS ID
1004985
Contact name
Luke Duthie
Contact email
Sponsor organisation
Telios Pharma, Inc.
Eudract number
2021-005724-38
Clinicaltrials.gov Identifier
Research summary
Myelofibrosis (MF) is an uncommon blood cancer. It causes scarring within the bone marrow which means blood cells are not made properly. People with MF may have too few red blood cells (known as anaemia) or the blood cells may build up in the spleen (an organ in the abdomen) causing it to enlarge. MF is part of a group of conditions known as myeloproliferative neoplasms or myeloproliferative disorders.
Symptoms include feeling tired, weak, or short of breath and a pain or fullness below your ribs on the left side. Other symptoms include easy bruising, easy bleeding, excessive sweating during sleep (night sweats), and fever.MF can affect anyone, but it is most often diagnosed in people over 50 years old.
Treatment for MF depends on a number of factors including blood count at diagnosis and symptoms. Treatments can include blood transfusions, low dose aspirin, chemotherapy, and treatment with a type of medicine called a Janus kinase (JAK) inhibitor. JAK inhibitors stop a gene from signalling to stem cells to make blood cells. An example of a JAK inhibitor is ruxolitinib, which is taken as a tablet. Ruxolitinib is an approved drug in the UK for patients with MF.
Patients treated with JAK inhibitors often continue to experience some symptoms of MF.
TL-895 is an investigational medicine. Investigational means it is not yet approved for everyday use and can only be used in clinical trials such as this one.
The purpose of this study is to determine if TL-895 is well-tolerated and effective at treating MF in combination with ruxolitinib instead of ruxolitinib alone. Patients in this study will receive TL-895 (a tablet) along with ruxolitinib.
Telios Pharma, Inc. (the Sponsor) is responsible for the development of TL-895 and the oversight of this study. Approximately 70 patients are expected to take part in this study at medical centres in North America, South America, and Europe, including the UK.
REC name
West of Scotland REC 1
REC reference
22/WS/0081
Date of REC Opinion
27 Jul 2022
REC opinion
Further Information Favourable Opinion