drugset / Trial / NCT03285178

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

NCT03285178 ↗

Phase 2 Completed 88 enrolled Cyclerion Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2017-12-22
Primary completion
2020-07-22
Completion
2020-07-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Olinciguat Small molecule 2 mg Oral
Subject Olinciguat Small molecule 4 mg Oral
Subject Olinciguat Small molecule 6 mg Oral
Subject Olinciguat Small molecule 18 mg Oral

Indications