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

NCT04053803 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IMR-SCD-102-EXT2018-003805-25
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (4)

• Proportion of patients with adverse events and serious adverse events

  1. Incidence of Adverse Events 2. 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

  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

  Baseline to Month 49

Study Arms (1)

Open Label

EXPERIMENTAL

Drug: IMR-687

Interventions

IMR-687 DRUG

Oral administration of once daily IMR-687

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed Study IMR-SCD-102.
• 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.
• 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
• Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.

You may not qualify if:

• Subjects with Hb \>12.5 g/dL or \<6 g/dL
• 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)
• eGFR \<50 mL/min
• AST/ALT \> 3x the upper limit of normal

Sponsors & Collaborators

• Imara, Inc.: lead

Study Sites (7)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Foundation for Sickle Cell Disease Research

Hollywood, Florida, 33021, United States

Location

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508, United States

Location

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Location

University College London Hospital NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

Guy's and St Thomas Hospital CRF

London, United Kingdom

Location

Royal London Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Karen Tang, MD

  Imara, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: August 13, 2019
• Study Start: May 22, 2019
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

US (3); GB (4)