NCT03285178

A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)

A Randomized, Placebo-controlled, Phase 2 Study to Evaluate the Safety and Pharmacodynamics of Once-daily Oral IW-1701 in Patients With Stable Sickle Cell Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Cyclerion Therapeutics · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the 1701-202 STRONG SCD study is to evaluate the safety and tolerability of different dose levels of IW-1701 compared with placebo when administered daily for approximately 12 weeks to patients with stable SCD. Exploratory objectives include evaluation of pharmacokinetic (PK) as well as evaluation of the effect of IW-1701 on symptoms of SCD, health-related quality of life, and biomarkers of pharmacodynamic (PD) activity.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	IW-1701	Oral Tablet
DRUG	Placebo	Oral Tablet

Timeline

• Start date: 2017-12-22
• Primary completion: 2020-07-22
• Completion: 2020-07-22
• First posted: 2017-09-15
• Last updated: 2023-07-21
• Results posted: 2023-07-21

Locations

37 sites across 3 countries: United States, Lebanon, United Kingdom

Regulatory

• FDA-regulated drug study