CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 160 target
Drug / intervention
Elriterceptdrug
Likely dose
Not stated in record
Key inclusion· 16
  • Age ≥18 years at informed consent
  • ECOG performance status 0-2 (if PS 2, must be related to anemia)
  • Part 1: MDS with IPSS-R very low, low, or intermediate risk
  • Part 1: <5% blasts in bone marrow
Key exclusion· 28
  • MDS with deletion of chromosome 5q (Del5q)
  • Secondary MDS from chemical injury or prior chemotherapy/radiation
  • Active infection requiring parenteral antibiotics within 28 days or oral antibiotics within 14 days
  • Uncontrolled heart disease or NYHA Class III/IV heart failure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04419649
NCT04419649Phase 2RecruitingOn TrackUpdated 4mo ago
Long Recruiting

A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

Takeda·interventional·Posted Jun 5, 2020·Updated Feb 6, 2026

In Brief

A Phase 2 clinical trial evaluating Elritercept for Myelodysplastic Syndromes and Cytopenia. Currently recruiting, targeting 160 participants across 47 sites in 8 countries.

Detailed Summary

The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Czechia, France, Germany, Israel, New Zealand, Spain, United States
Collaborators--

Timeline

Phase 2Recruiting
202120222023202420252026202720282029203020312032
First PostedJun 5, 2020
Enrollment StartAug 19, 2020
Primary CompletionOct 30, 2029
Study CompletionOct 30, 2031
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 6.1 years agoPrimary completion in 3.3 years

Interventions

Elriterceptdrug

Elritercept SC injection.