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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 : Recruiting
First Posted : January 17, 2018
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Imara, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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 : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Thalassemia

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




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. Maximum plasma concentration of IMR-687 (Cmax) [ Time Frame: 1, 4 and 12 weeks ]
  2. Area under the Curve (AUC) of IMR-687 [ Time Frame: 1, 4 and 12 weeks ]
  3. Maximum plasma concentration of hydroxyurea [ Time Frame: Baseline and 4 weeks ]
  4. Area under the curve (AUC) of hydroxyurea [ Time Frame: Baseline and 4 weeks ]


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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


Contacts
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Contact: Eleanor Lisbon, MD, MPH +1 913-449-4319 ELisbon@imaratx.com

Locations
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United States, California
UCSF Benioff Children's Hospital Oakland Recruiting
Oakland, California, United States, 94609
Contact: Kacie Smith       kasmith@mail.cho.org   
United States, Connecticut
University of Connecticut Health Center (UCONN Health) Recruiting
Farmington, Connecticut, United States, 06030
Contact: Sasia Jones       sajones@uchc.edu   
United States, Florida
Foundation for Sickle Cell Disease Research Recruiting
Hollywood, Florida, United States, 33021
Contact: Lanetta Bronte       LBronte@fscdr.org   
United States, Georgia
Primary Care Research Center Active, not recruiting
Atlanta, Georgia, United States, 30312
United States, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Lani Krauz       lignacio@uic.edu   
Loretto Hospital Recruiting
Chicago, Illinois, United States, 60644
Contact: Maina Palumbo       Marina.Palumbo@acri-research.com   
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Kaitlyn Walker       WALKERKAI16@ECU.EDU   
United States, South Carolina
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
United Kingdom
Birmingham and Sandwell Recruiting
Birmingham, United Kingdom
Contact: Elizabeth Green         
Croydon University Hospital Recruiting
Croydon, United Kingdom, CR7 7YE
Contact: Linda Sawyer         
Darent Valley Hospital Recruiting
Dartford, United Kingdom, DA2 8DA
Whittington Hospital Recruiting
London, United Kingdom, N19 5NF
University College Hospital (UCLH) Recruiting
London, United Kingdom, NW1 2BU
Contact: Alyna Sheikh         
University Hospital Lewisham Recruiting
London, United Kingdom, SE13 6LH
Kings College Hospital Recruiting
London, United Kingdom, SE5 9RS
Guy's and St Thomas Hospital Recruiting
London, United Kingdom
Contact: Yemi Adelaja         
Homerton Hospital Recruiting
London, United Kingdom
Contact: Anna Price         
Sponsors and Collaborators
Imara, Inc.
Investigators
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Principal Investigator: Timothy Mant, MB FFPM FRCP Guy's and St Thomas Hospital CRF

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Responsible Party: Imara, Inc.
ClinicalTrials.gov Identifier: NCT03401112     History of Changes
Other Study ID Numbers: IMR-SCD-102
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
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, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn