A Study of IMR-687 in Subjects With Sickle Cell Disease
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ClinicalTrials.gov Identifier: NCT04474314 |
Recruitment Status :
Terminated
(A recently conducted Interim analysis of IMR-SCD-301 demonstrated that while IMR-687 was generally well-tolerated, it failed to meet its primary efficacy endpoint. So, the sponsor has decided to discontinue this study.)
First Posted : July 16, 2020
Last Update Posted : May 13, 2022
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Sponsor:
Imara, Inc.
Information provided by (Responsible Party):
Imara, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | June 26, 2020 | ||||
First Posted Date ICMJE | July 16, 2020 | ||||
Last Update Posted Date | May 13, 2022 | ||||
Actual Study Start Date ICMJE | August 13, 2020 | ||||
Actual Primary Completion Date | March 2, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of IMR-687 in Subjects With Sickle Cell Disease | ||||
Official Title ICMJE | A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects With Sickle Cell Disease | ||||
Brief Summary | A Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease | ||||
Detailed Description | A phase 2b, randomized, double-blind, placebo-controlled, multicenter study of subjects with sickle cell disease (SCD; homozygous sickle hemoglobin [HbSS], sickle-β0 [HbSβ0] thalassemia, or sickle-β+ [HbSβ+] thalassemia) to evaluate the safety and efficacy of the phosphodiesterase type 9 (PDE9) inhibitor, IMR-687, administered once daily (qd) for 52 weeks. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Masking Description: Double-Blind Primary Purpose: Treatment
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Condition ICMJE | Sickle Cell Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
115 | ||||
Original Estimated Enrollment ICMJE |
99 | ||||
Actual Study Completion Date ICMJE | May 4, 2022 | ||||
Actual Primary Completion Date | March 2, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Ghana, Greece, Italy, Kenya, Lebanon, Morocco, Netherlands, Oman, Senegal, Tunisia, Uganda, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04474314 | ||||
Other Study ID Numbers ICMJE | IMR-SCD-301 2019-004471-39 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Imara, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Imara, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Imara, Inc. | ||||
Verification Date | March 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |