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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
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Imara, Inc.

Study Description
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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

Detailed Description:
This is a proof-of-concept study in adult SCA patients, ages 18 to 55 years old, to examine the safety, tolerability, and PK, as well as the potential PD effects and clinical efficacy, of IMR-687 across a range of doses.
Study Design
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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
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: IMR-687
Oral administration of once daily IMR-687
Experimental: Dose 1
IMR-687
 Drug: IMR-687
Oral administration of once daily IMR-687
Experimental: Dose 2
IMR-687
 Drug: IMR-687
Oral administration of once daily IMR-687


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with adverse events and serious adverse events [ Time Frame: Baseline to Week 24 ]
    1. Incidence of Adverse Events
    2. Incidence of Serious Adverse Events

  2. Proportion of patients with changes in safety cardiac parameters [ Time Frame: Baseline to Week 24 ]

    1. 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.

    2. Changes in 12-lead ECG parameters that are clinically significant and interpreted by the investigator as consistent with ischemia or infarction.

  3. 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

  4. Proportion of patients with clinically significant abnormal vital signs [ Time Frame: Baseline to Week 24 ]
    1. Blood pressure measured in mmHg
    2. Pulse measured in beats per minute
    3. Respiration rate measured in breaths per minutes
    4. Temperature as measured in degrees F0 or C0


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. PK of hydroxyurea: Maximum plasma concentration of hydroxyurea [ Time Frame: Baseline and 4 weeks ]
    Cmax will be recorded from the PK serum samples collected.

  4. 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


Eligibility Criteria
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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
Contacts and Locations
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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
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Sponsors and Collaborators
Imara, Inc.
Investigators
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Principal Investigator: Timothy Mant, MB FFPM FRCP Guy's and St Thomas Hospital CRF
More Information
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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: July 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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