A Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)
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| ClinicalTrials.gov Identifier: NCT03401112 |
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Recruitment Status :
Completed
First Posted : January 17, 2018
Last Update Posted : January 19, 2021
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Sponsor:
Imara, Inc.
Information provided by (Responsible Party):
Imara, Inc.
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Brief Summary:
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients with Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sickle Cell Disease | Drug: IMR-687 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Double-blind |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia) |
| Actual Study Start Date : | January 26, 2018 |
| Actual Primary Completion Date : | August 28, 2020 |
| Actual Study Completion Date : | August 28, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Sickle cell disease
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo |
Drug: IMR-687
Oral administration of once daily IMR-687 |
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Experimental: Dose 1
IMR-687
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Drug: IMR-687
Oral administration of once daily IMR-687 |
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Experimental: Dose 2
IMR-687
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Drug: IMR-687
Oral administration of once daily IMR-687 |
Primary Outcome Measures :
- Proportion of patients with adverse events and serious adverse events [ Time Frame: Baseline to Week 24 ]
- Incidence of Adverse Events
- Incidence of Serious Adverse Events
- Proportion of patients with changes in safety cardiac parameters [ Time Frame: Baseline to Week 24 ]
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Changes in 12-lead ECG parameters that are clinically significant and measured in milliseconds (ms).
The parameters are: PR interval, QRS duration, QT interval, ST segment duration and T wave duration.
- Changes in 12-lead ECG parameters that are clinically significant and interpreted by the investigator as consistent with ischemia or infarction.
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- Proportion of patients with changes in clinical laboratory tests [ Time Frame: Baseline to Week 24 ]a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis
- Proportion of patients with clinically significant abnormal vital signs [ Time Frame: Baseline to Week 24 ]
- Blood pressure measured in mmHg
- Pulse measured in beats per minute
- Respiration rate measured in breaths per minutes
- Temperature as measured in degrees F0 or C0
Secondary Outcome Measures :
- PK of IMR-867: Maximum plasma concentration of IMR-687 (Cmax) [ Time Frame: 1, 4 and 12 weeks ]Cmax will be recorded from the PK serum samples collected.
- PK of IMR-867: Area under the Curve (AUC) of IMR-687 [ Time Frame: 1, 4 and 12 weeks ]AUC will be recorded from the PK serum samples collected
- PK of hydroxyurea: Maximum plasma concentration of hydroxyurea [ Time Frame: Baseline and 4 weeks ]Cmax will be recorded from the PK serum samples collected.
- PK of hydroxyurea: Area under the curve (AUC) of hydroxyurea [ Time Frame: Baseline and 4 weeks ]AUC will be recorded from the PK serum samples collected
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients with confirmed SCA
- Age 18-55 years, inclusive
- For patients on hydroxyurea, must have been on a stable dose for at least 60 days prior to screening
Exclusion Criteria:
- Total hemoglobin >12.5 or less than 6 g/dL
- RBC transfusion within 60 days of baseline
- >7 hospitalizations for vasoocclusive crises within the last year
- eGFR < 50 ml/min
- AST/ALT > 3x the upper limit of normal
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): NCT03401112
Locations
Show 24 study locations
Sponsors and Collaborators
Imara, Inc.
Investigators
| Principal Investigator: | Timothy Mant, MB FFPM FRCP | Guy's and St Thomas Hospital CRF |
| Responsible Party: | Imara, Inc. |
| ClinicalTrials.gov Identifier: | NCT03401112 |
| Other Study ID Numbers: |
IMR-SCD-102 2017-000653-39 ( EudraCT Number ) |
| First Posted: | January 17, 2018 Key Record Dates |
| Last Update Posted: | January 19, 2021 |
| Last Verified: | January 2021 |
| 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 |
Additional relevant MeSH terms:
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Anemia, Sickle Cell Thalassemia Anemia Hematologic Diseases |
Anemia, Hemolytic, Congenital Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn |