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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04053803
• Other study ID #: IMR-SCD-102-EXT
• Secondary ID: 2018-003805-25
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 22, 2019
• Est. completion date: March 2025

Study information

• Verified date: March 2022
• Source: Imara, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• IMR-687
Oral administration of once daily IMR-687

Locations

Country	Name	City	State
United Kingdom	Bristol Haematology and Oncology Centre	Bristol
United Kingdom	Guy's and St Thomas Hospital CRF	London
United Kingdom	Royal London Hospital	London
United Kingdom	University College London Hospital NHS Foundation Trust	London
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Foundation for Sickle Cell Disease Research	Hollywood	Florida
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Imara, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with adverse events and serious adverse events	Incidence of Adverse Events; Incidence of Serious Adverse Events	Baseline to Month 49
Primary	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
Primary	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
Primary	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