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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |