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A Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE January 2, 2018
First Posted Date  ICMJE January 17, 2018
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE January 26, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • 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
  • 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.
  • 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 ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
Incidence of treatment-emergent adverse events (safety and tolerability). [ Time Frame: Baseline to Week 24 ]
Proportion of patients with adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
  • Maximum plasma concentration of IMR-687 (Cmax) [ Time Frame: 1, 4 and 12 weeks ]
  • Area under the Curve (AUC) of IMR-687 [ Time Frame: 1, 4 and 12 weeks ]
  • Maximum plasma concentration of hydroxyurea [ Time Frame: Baseline and 4 weeks ]
  • Area under the curve (AUC) of hydroxyurea [ Time Frame: Baseline and 4 weeks ]
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 Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Official Title  ICMJE 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)
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).
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 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
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Drug: IMR-687
Oral administration of once daily IMR-687
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: IMR-687
  • Experimental: Dose 1
    IMR-687
    Intervention: Drug: IMR-687
  • Experimental: Dose 2
    IMR-687
    Intervention: Drug: IMR-687
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 2, 2020)
100
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2018)
54
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03401112
Other Study ID Numbers  ICMJE IMR-SCD-102
2017-000653-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imara, Inc.
Study Sponsor  ICMJE Imara, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy Mant, MB FFPM FRCP Guy's and St Thomas Hospital CRF
PRS Account Imara, Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP