A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)
NCT ID: NCT03401112
Last Updated: 2025-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2018-01-26
2020-08-28
Brief Summary
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Detailed Description
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IMR-687 was administered in 2 populations of participants with SCA: those who were not receiving hydroxyurea (HU) and those who were receiving a stable dose of HU according to standard of care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IMR-687 50 mg/100 mg
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants. Duration of administration was 16 (Week 17) or 24 weeks (Week 25).
IMR-687
Oral administration of IMR-687 once daily with or without HU.
IMR-687 100 mg/200 mg
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants. Duration of administration was 24 weeks (Week 25).
IMR-687
Oral administration of IMR-687 once daily with or without HU.
Placebo
Matching placebo was administered for 16 (Week 17) or 24 weeks (Week 25).
Placebo
Oral administration of placebo once daily with or without HU.
Interventions
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IMR-687
Oral administration of IMR-687 once daily with or without HU.
Placebo
Oral administration of placebo once daily with or without HU.
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 55 years, inclusive
* For participants on HU, must have been on a stable dose for at least 60 days prior to screening
Exclusion Criteria
* Red blood cell transfusion within 60 days of baseline
* \>7 hospitalizations for vaso-occlusive crises (VOCs) within the last year
* Estimated glomerular filtration rate \<50 milliliter/minute
* Aspartate aminotransferase/alanine aminotransferase \>3x the upper limit of normal
18 Years
55 Years
ALL
No
Sponsors
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Imara, Inc.
INDUSTRY
Cardurion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Regulatory Operations
Role: STUDY_DIRECTOR
Cardurion Pharmaceuticals
Locations
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UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States
University of Illinois
Chicago, Illinois, United States
Loretto Hospital
Chicago, Illinois, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor Scott & White Health
Temple, Texas, United States
Sandwell & West Birmingham Hospital
Birmingham, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Royal London Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
Oxford Cancer & Haematology Centre, The Churchill Hospital
Oxford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-000653-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IMR-SCD-102
Identifier Type: -
Identifier Source: org_study_id
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