The Efficacy and Safety of Elritercept in Adults With Very Low to Intermediate Risk MDS With Anemia
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)
IRAS ID
1010708
Contact name
Miranda Ross
Contact email
Sponsor organisation
Keros Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
This trial is evaluating the experimental drug elritercept to see if it may safely and effectively reduce the need for blood transfusions due to myelodysplastic neoplasms/syndromes (MDS)-related anaemia.
Participants in this trial will have a 2 in 3 (67%) chance of receiving elritercept and a 1 in 3 (33%) chance of receiving a placebo (medicine that looks like the study drug but contains no active ingredient).
Study treatment will be given as subcutaneous (under the skin) injections once every 4 weeks.
The time a participant spends in the trial will depend on how they respond to treatment. After the trial doctors confirm participants are eligible to join (which could take up to 6 weeks), participants will enter the trial's treatment period, which will be done in 3 parts. In Part 1, participants will get elritercept or placebo for 24 weeks and may, if they are benefiting from treatment and their MDS has not progressed, then continue treatment in Part 2 (for another 24 weeks) and further in Part 3 (until they or the trial doctor decide to stop treatment). Trial doctors will assess a participant’s MDS during treatment through bone marrow and blood exams every 24 weeks. After the last participant completes Part 2, participants receiving elritercept in Part 3 may continue treatment for as long as they are benefitting and their MDS is not progressing. Participants receiving placebo in Part 3 will stop treatment in the trial at this point and continue their standard MDS treatment outside the trial.
During the trial, participants will visit hospital regularly so trial doctors can monitor their health. After participants finish treatment, they will visit hospital 1 time as soon as possible then 2 more times within 8 weeks for follow-up health checks. Thereafter, participants will have follow-up checks every 3 months, for up to 5 years from their first dose of trial treatment or 3 years after their last dose, so trial doctors can monitor their MDS and overall condition.REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0375
Date of REC Opinion
16 Dec 2024
REC opinion
Further Information Favourable Opinion