NCT04411082

A Study of IMR-687 in Subjects With Beta Thalassemia

A Phase 2 Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects With Beta Thalassemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Cardurion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia

Detailed description

A phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of IMR-687 (phosphodiesterase (PDE) 9 inhibitor) administered once daily (qd) orally for 36 weeks in 2 populations of adult subjects with β-thalassemia: Population 1 (Transfusion Dependent Thalassemia (TDT) subjects) and Population 2 (Non-Transfusion Dependent Thalassemia (NTDT) subjects).

Conditions

• β Thalassemia

Interventions

Type	Name	Description
DRUG	IMR-687	Oral administration of once daily IMR-687
DRUG	Placebo	Oral administration of once daily Placebo

Timeline

• Start date: 2020-10-16
• Primary completion: 2022-03-11
• Completion: 2022-05-04
• First posted: 2020-06-02
• Last updated: 2025-05-15
• Results posted: 2022-06-30

Locations

36 sites across 13 countries: Denmark, France, Georgia, Greece, Israel, Italy, Lebanon, Malaysia, Morocco, Netherlands, Tunisia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study