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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)

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ClinicalTrials.gov Identifier: NCT03285178
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

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

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. Patient has had at least 1 and no more than 10 protocol-defined sickle cell related pain crises in the 12 months before the Screening Visit and none 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 in the 4 weeks before the Randomization Visit.
  3. Patient has taken opioid(s) >90 morphine mg equivalent/day within the 4 weeks before the Randomization Visit.
  4. Patient is taking aspirin, 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
Contact: Meghan Bratton 617-894-5374 mbratton@ironwoodpharma.com

Locations
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 Recruiting
Hollywood, Florida, United States, 33021
Contact: Study Coordinator    954-397-3251      
United States, Louisiana
Clinical Trials of SWLA, LLC Recruiting
Lake Charles, Louisiana, United States, 70601
Contact: Study Coordinator    337-602-6642      
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      
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03285178     History of Changes
Other Study ID Numbers: C1701-202
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Ironwood Pharmaceuticals, Inc.:
Sickle Cell Disease
SCD

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