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



Status:Recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:16 - 70
Updated:4/5/2019
Start Date:December 22, 2017
End Date:July 2019
Contact:Holly John
Email:hjohn@cyclerion.com
Phone:(857) 338-3303

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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

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.


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
We found this trial at
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-3748
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Phone: 714-509-8423
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Phone: 404-881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Phone: 404-778-1311
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Aventura, Florida 33180
Phone: 305-759-1881
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Baltimore, Maryland 21205
Phone: 410-502-8642
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Phone: 410-328-7931
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baytown, Texas 77521
Phone: 281-481-8557
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
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Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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Detroit, Michigan 33021
Phone: 313-993-8825
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232 Main Street Northwest
Flossmoor, Illinois 60422
Phone: 708-388-2245
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1410 Lpga Boulevard
Fort Lauderdale, Florida 32117
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Greenville, North Carolina 27834
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Hackensack, New Jersey 07601
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Hazelwood, Missouri 63042
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Jenkintown, Pennsylvania 19046
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1 Lakeshore Drive
Lake Charles, Louisiana 70601
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7912 Forest City Road
Orlando, Florida 32810
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Pittsburgh, Pennsylvania 15232
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Tulsa, Oklahoma 74105
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Washington, District of Columbia 20010
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1840 7th Street Northwest
Washington, District of Columbia 20001
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Wauwatosa, Wisconsin 53226
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