NCT04474314

A Study of IMR-687 in Subjects With Sickle Cell Disease

A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects With Sickle Cell Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (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 Efficacy of IMR-687 in Subjects with Sickle Cell Disease

Detailed description

A phase 2b, randomized, double-blind, placebo-controlled, multicenter study of subjects with sickle cell disease (SCD; homozygous sickle hemoglobin \[HbSS\], sickle-β0 \[HbSβ0\] thalassemia, or sickle-β+ \[HbSβ+\] thalassemia) to evaluate the safety and efficacy of the phosphodiesterase type 9 (PDE9) inhibitor, IMR-687, administered once daily (qd) for 52 weeks.

Conditions

• Sickle Cell Disease

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: 2020-08-13
• Primary completion: 2022-03-02
• Completion: 2022-05-04
• First posted: 2020-07-16
• Last updated: 2025-05-15
• Results posted: 2023-10-18

Locations

49 sites across 13 countries: United States, Ghana, Greece, Italy, Kenya, Lebanon, Morocco, Netherlands, Oman, Senegal, Tunisia, Uganda, United Kingdom

Regulatory

• FDA-regulated drug study