NCT06887803

A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors

A Phase I/II Open-Label, Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to an Approved JAK Inhibitors (HEMA-MED)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: iOnctura · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn how roginolisib works in comparison to standard treatment in adult patients with Myelofibrosis. The main questions it aims to answer is to evaluate the safety and tolerability of roginolisib when administered in combination with ruxolitinib.

Detailed description

A Phase I/II Open-Label, Single Arm Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) who are Unresponsive to JAK inhibitors (HEMA-MED). This study will enrol approximately 26 male and female patients aged over 18 years with MF, who have been treated with ruxolitinib for ≥ 3 months with a stable dose ≥ 10 mg for at least the last 8 weeks prior to Day 1 and no significant spleen reduction. The study will initially enrol 13 patients in Part 1 to assess the benefit/risk profile of roginolisib when combined with ruxolitinib. Part 2 will enrol an additional 13 patients to further characterize the benefit/risk.

Conditions

• Myelofibrosis (MF)

Interventions

Type	Name	Description
DRUG	Roginolisib	IOA-244: 80 mg (corresponding to 72 mg roginolisib) Ruxolitinib: up to 25 mg BD

Timeline

• Start date: 2025-11-17
• Primary completion: 2028-03-01
• Completion: 2028-07-01
• First posted: 2025-03-20
• Last updated: 2026-01-16

Locations

7 sites across 2 countries: Italy, Spain