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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 : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Imara, Inc.

Study Description
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Brief Summary:
A Phase 2a randomized, placebo-controlled, multicenter study of orally administered IMR-687 in adults with Sickle Cell Anaemia (SCA).

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, age 18-50 years old. The primary goal is to examine the safety, pharmacokinetics and preliminary pharmacodynamics of escalating doses of IMR-687 as compared to placebo.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 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 : June 2019
Estimated Study Completion Date : June 2019

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: PBO 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. Incidence of treatment-emergent adverse events (safety and tolerability). [ Time Frame: Baseline to Week 24 ]
    Proportion of patients with adverse events


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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients with confirmed SCD
  • Age 18-50 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 >11 or less than 6 g/dL
  • RBC transfusion within 60 days of baseline
  • >3 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


Contacts
Contact: Joe Datt, MD, MRCPCH +447900-801804 JDatt@imaratx.com

Locations
United States, Connecticut
University of Connecticut Health Center (UCONN Health) Recruiting
Farmington, Connecticut, United States, 06030
Contact: Sasia Jones         
Principal Investigator: Biree Andemariam, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Emily Warner         
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: Jaspreet Kaur         
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: Jitka Fucikova         
Homerton Hospital Recruiting
London, United Kingdom
Contact: Anna Price         
Sponsors and Collaborators
Imara, Inc.
Investigators
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     History of Changes
Other Study ID Numbers: IMR-SCD-102
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
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:
Anemia, Sickle Cell
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn