NCT05693909

A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes

An Open-label, Dose-escalation, Dose-finding, and Proof-of-concept Trial of SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about SP-420 ability to remove iron from organs in subjects with transfusion-dependent β-thalassemia or transfusion-dependent low-risk myelodysplastic syndrome. The main questions it aims to answer are: * How efficient is SP-420 in cleaning iron from the liver? * How is the safety and tolerability of ascending doses of SP-420? Participants will: * Take medication three times weekly * Attend up to 20 site visits * Undergo MRI scans

Conditions

• Beta Thalassemia Major Anemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	SP-420	Capsules for oral intake

Timeline

• Start date: 2023-09-04
• Primary completion: 2027-10-01
• Completion: 2028-05-01
• First posted: 2023-01-23
• Last updated: 2025-09-24

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study