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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT03285178

Run by

Cyclerion Therapeutics

People needed

88

Starts

2017-12-22

Expected to finish

2020-07-22

Last updated by the study team

2023-07-21

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is ambulatory male or female 16 to 70 years of age at the Screening Visit.
• Patient has SCD, including homozygous hemoglobin S (HbSS), hemoglobin SC disease (HbSC), heterozygous hemoglobin S-beta zero (HbSβ0)-thalassemia, or heterozygous hemoglobin S-beta plus (HbSβ+)-thalassemia, documented in their medical history.
• If patient is on medication(s) for SCD, such as hydroxyurea (HU), are on a stable regimen.
• Per medical history and/or patient recall, patient has had at least 1 and no more than 10 sickle cell-related pain crises in the 12 months before the Screening Visit and none occurring in the 4 weeks before the Randomization Visit.
• Patient completes daily eDiary entries for at least 10 days during the last 14 days of the Run in Period as assessed at the Randomization Visit.
• Women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the Screening Visit through 90 days after the final dose of study drug.
• Male patients must be surgically sterile by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception and agree to refrain from sperm donation from the Screening Visit through 90 days after the final dose of study drug.

You may not qualify if…

• Patient requires a program of prescheduled, regularly administered chronic blood transfusion therapy.
• Patient has been hospitalized for an SCD-related complication in the 4 weeks before the Randomization Visit.
• Patient has taken opioid(s) >200 morphine mg equivalent/day within the 4 weeks before the Randomization Visit.
• Patient is taking aspirin ≥325 mg daily, P2Y12 inhibitors, any anticoagulant medication, specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors of phosphodiesterase 5 (PDE5), moderate or strong cytochrome P450 3A (CYP3A) inhibitors, any supplements for the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide donors in any form.
• Patient has major concurrent illness or medical condition that in the opinion of the Investigator would preclude participation in a clinical study.
• NOTE: Other inclusion and exclusion criteria apply, per protocol

Where it is running

• Children's Hospital of Orange County — Orange, California, United States
• MedStar Health Research Institute, MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Howard University Center for Sickle Cell Disease — Washington D.C., District of Columbia, United States
• Innovative Medical Research of South Florida, Inc. — Aventura, Florida, United States
• Century Clinical Research, Inc. — Fort Lauderdale, Florida, United States
• Foundation for Sickle Cell Disease Research — Hollywood, Florida, United States
• Omega Research Maitland, LLC — Orlando, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Healthcare Research Network II, LLC — Flossmoor, Illinois, United States
• Clinical Trials of SWLA, LLC — Lake Charles, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins School of Medicine Children's Center — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Hospital of Michigan-Detroit — Detroit, Michigan, United States
• Healthcare Research Network — Hazelwood, Missouri, United States
• Hackensack University Medical Center, Pediatric Hematology and Oncology — Hackensack, New Jersey, United States
• Jacobi Medical Center — The Bronx, New York, United States
• New York Medical College — Valhalla, New York, United States
• East Carolina University - Leo W. Jenkins Cancer Center — Greenville, North Carolina, United States
• East Carolina University Brody School of Medicine, Department of Pediatrics, Division of Pediatric Hematology — Greenville, North Carolina, United States
• Lynn Institute of Tulsa — Tulsa, Oklahoma, United States
• The Clinical Trial Center LLC — Jenkintown, Pennsylvania, United States
• University of Pittsburgh Medical Center Hillman Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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