An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia

An Open-label Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia) Who Participated in Study IMR-SCD-102

This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerability.

Study Overview

• Status: Active, not recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Drug: IMR-687

Detailed Description

This is an open-label extension study of IMR-687 in adult patients with SCA who were previously participants in the Phase 2a study titled "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)."

This open-label extension study with IMR-687 will evaluate the long-term safety and tolerability of IMR 687 in adult SCA patients. Exploratory long-term PD parameters will also be examined.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom
    • Bristol Haematology and Oncology Centre
  • London, United Kingdom
    • Royal London Hospital
  • London, United Kingdom, NW1 2PG
    • University College London Hospital NHS Foundation Trust
  • London, United Kingdom
    • Guy's and St Thomas Hospital CRF
• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
  • Florida
    • Hollywood, Florida, United States, 33021
      • Foundation for Sickle Cell Disease Research
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Medical Center - Temple

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Completed Study IMR-SCD-102.
2. Female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
3. Subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them
4. Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.

Exclusion Criteria:

1. Subjects with Hb >12.5 g/dL or <6 g/dL
2. Subjects with known active hepatitis B or hepatitis C, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (HIV)
3. eGFR <50 mL/min
4. AST/ALT > 3x the upper limit of normal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label	Drug: IMR-687; Oral administration of once daily IMR-687

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with adverse events and serious adverse events	Incidence of Adverse Events; Incidence of Serious Adverse Events	Baseline to Month 49
Proportion of patients with changes in safety cardiac parameters	a. 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.	Baseline to Month 49
Proportion of patients with changes in clinical laboratory tests	a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis	Baseline to Month 49
Proportion of patients with clinically significant abnormal vital signs	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	Baseline to Month 49

Collaborators and Investigators

• Sponsor: Imara, Inc.
• Investigators: Study Director: Karen Tang, MD, Imara, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: IMR-SCD-102-EXT; 2018-003805-25 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No