Status:
COMPLETED
A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)
Lead Sponsor:
Cyclerion Therapeutics
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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.
- EXCLUSION CRITERIA
- 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
Exclusion
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2020
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03285178
Start Date
December 22 2017
End Date
July 22 2020
Last Update
July 21 2023
Active Locations (37)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868
2
MedStar Health Research Institute, MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Howard University Center for Sickle Cell Disease
Washington D.C., District of Columbia, United States, 20060
4
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, United States, 33180