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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03285178
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

Brief Summary:
The primary objective of the 1701-202 STRONG SCD study is to evaluate the safety and tolerability of 3 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 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: IW-1701 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IW-1701 Low Dose Drug: IW-1701
Oral Tablet

Experimental: IW-1701 Medium Dose Drug: IW-1701
Oral Tablet

Experimental: IW-1701 High Dose Drug: IW-1701
Oral Tablet

Placebo Comparator: Placebo Drug: Placebo
Oral Tablet




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs [ Time Frame: From first dose of study treatment through Follow-Up Visit (Day 113 -3/+7 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Patient is ambulatory male or female 16 to 70 years of age at the Screening Visit.
  2. Patient has SCD, including HbSS, HbSC, HbSβ0-thalassemia, or HbSβ+-thalassemia, documented in their medical history.
  3. If patient is on medication(s) for SCD, such as hydroxyurea (HU), are on a stable regimen.
  4. 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.
  5. 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.
  6. 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.
  7. 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

  1. Patient requires a program of prescheduled, regularly administered chronic blood transfusion therapy.
  2. Patient has been hospitalized for an SCD-related complication in the 4 weeks before the Randomization Visit.
  3. Patient has taken opioid(s) >200 morphine mg equivalent/day within the 4 weeks before the Randomization Visit.
  4. Patient is taking aspirin ≥325 mg daily, P2Y12 inhibitors, any anticoagulant medication, specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors of 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.
  5. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285178


Contacts
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Contact: Holly John (857) 338-3303 hjohn@cyclerion.com

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Locations
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United States, California
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Study Coordinator    714-509-8423      
United States, District of Columbia
MedStar Health Research Institute, MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Study Coordinator    202-877-3657      
Howard University Center for Sickle Cell Disease Recruiting
Washington, District of Columbia, United States, 20060
Contact: Study Coordinator    202-602-6642      
United States, Florida
Innovative Medical Research of South Florida, Inc. Recruiting
Aventura, Florida, United States, 33180
Contact: Study Coordinator    305-759-1881      
Century Clinical Research, Inc. Recruiting
Fort Lauderdale, Florida, United States, 32117
Contact: Study Coordinator    386-274-4750      
Foundation for Sickle Cell Disease Research Terminated
Hollywood, Florida, United States, 33021
Omega Research Maitland, LLC Recruiting
Orlando, Florida, United States, 32810
Contact: Study Coordinator    407-988-1075      
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Study Coordinator    404-778-1311      
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30331
Contact: Study Coordinator    404-881-5800      
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Study Coordinator    312-996-5984      
Healthcare Research Network II, LLC Recruiting
Flossmoor, Illinois, United States, 60422
Contact: Study Coordinator    708-388-2245      
United States, Louisiana
Clinical Trials of SWLA, LLC Recruiting
Lake Charles, Louisiana, United States, 70601
Contact: Study Coordinator    337-602-6642      
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Study Coordinator    410-328-7931      
Johns Hopkins School of Medicine Children's Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Study Coordinator    410-502-8642      
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Study Coordinator    617-355-3748      
United States, Michigan
Children's Hospital of Michigan-Detroit Recruiting
Detroit, Michigan, United States, 33021
Contact: Study Coordinator    313-993-8825      
United States, Missouri
Healthcare Research Network Recruiting
Hazelwood, Missouri, United States, 63042
Contact: Study Coordinator    314-972-9600      
United States, New Jersey
Hackensack University Medical Center, Pediatric Hematology and Oncology Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Study Coordinator    551-996-8178      
United States, New York
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Study Coordinator    718-918-5349      
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Study Coordinator    914-594-2134      
United States, North Carolina
East Carolina University - Leo W. Jenkins Cancer Center Recruiting
Greenville, North Carolina, United States, 27834
Contact: Study Coordinator    252-744-3556      
East Carolina University Brody School of Medicine, Department of Pediatrics, Division of Pediatric Hematology Recruiting
Greenville, North Carolina, United States, 27834
Contact: Study Coordinator    252-744-5807      
United States, Oklahoma
Lynn Institute of Tulsa Recruiting
Tulsa, Oklahoma, United States, 74105
Contact: Study Coordinator    918-289-0083      
United States, Pennsylvania
The Clinical Trial Center LLC Recruiting
Jenkintown, Pennsylvania, United States, 19046
Contact: Study Coordinator    215-884-1700      
University of Pittsburgh Medical Center Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Study Coordinator    412-802-8498      
United States, Texas
Accurate Clinical Research Recruiting
Baytown, Texas, United States, 77521
Contact: Study Coordinator    281-481-8557      
"UT Health Clinical Research Unit Center for Clinical and Translational Sciences Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-704-6417      
Mays Cancer Center UT Health San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-450-1827      
United States, Virginia
Virginia Commonwealth University - Clinical Research Unit Recruiting
Richmond, Virginia, United States, 23298
Contact: Study Coordinator    804-263-4068      
United States, Wisconsin
Blood Center of Wisconsin (BCW) Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Study Coordinator    414-937-6814      
Sponsors and Collaborators
Cyclerion Therapeutics

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Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT03285178     History of Changes
Other Study ID Numbers: C1701-202
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cyclerion Therapeutics:
Sickle Cell Disease
SCD

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn