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A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT 232 in Subjects with Primary Myelofibrosis (PMF), Post Polycythemia Vera MF (Post-PV-MF), Or Post Essential Thrombocythemia MF (Post-ET-MF) who are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513912-89-00
Acronym
KRT-232-101
Enrollment
253
Registered
2024-11-14
Start date
2018-12-13
Completion date
Unknown
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Or Secondary (Post-PV MF or Post-ET-MF) Myelofibrosis (MF) With Intermediate Or High-Risk TP53 Wild-Type (TP53 WT) Who Are Relapsed Or Refractory to Janus Kinase (JAK) - Inhibitor Treatment

Brief summary

Part A: The proportion of subjects achieving a ≥35% spleen volume reduction from Baseline to Week 24, as assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan., Part B: The proportion of subjects in each arm achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review)

Detailed description

Part A: Proportion of subjects with a reduction in total symptom score, Part A: To determine the duration of reduction of spleen volume, Part A: To determine the need for red blood cell (RBC) transfusion, Part A: The proportion of subjects who have RBC transfusion independence at week 24, Part A: To determine complete and partial remission of treated subjects, Part A: To determine time to death from any cause in treated subjects, Part A: To determine the pharmacokinetic/pharmacodynamic (PK/PD) profile of KRT-232, Part B: The proportion of subjects with reduction from Baseline to Week 24 in the total symptom score, Part B: Time from randomization to death from any cause, Part B: Progression free survival (PFS): time from randomization to either first occurrence of disease progression or death due to any cause, Part B: The proportion of subjects in each arm achieving spleen volume reduction, Part B: Time from initial spleen volume reduction until the first occurrence of disease progression, Part B: The proportion of subjects who have red blood cell transfusion independence at week 24

Interventions

Sponsors

Kartos Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A: The proportion of subjects achieving a ≥35% spleen volume reduction from Baseline to Week 24, as assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan., Part B: The proportion of subjects in each arm achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review)

Secondary

MeasureTime frame
Part A: Proportion of subjects with a reduction in total symptom score, Part A: To determine the duration of reduction of spleen volume, Part A: To determine the need for red blood cell (RBC) transfusion, Part A: The proportion of subjects who have RBC transfusion independence at week 24, Part A: To determine complete and partial remission of treated subjects, Part A: To determine time to death from any cause in treated subjects, Part A: To determine the pharmacokinetic/pharmacodynamic (PK/PD) profile of KRT-232, Part B: The proportion of subjects with reduction from Baseline to Week 24 in the total symptom score, Part B: Time from randomization to death from any cause, Part B: Progression free survival (PFS): time from randomization to either first occurrence of disease progression or death due to any cause, Part B: The proportion of subjects in each arm achieving spleen volume reduction, Part B: Time from initial spleen volume reduction until the first occurrence of disease progressi

Countries

Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, Italy, Lithuania, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026