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

Locations

4 United Kingdom sites

3 United States sites

Age

> 18 Years

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

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.

participation requirements

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.

participation restrictions

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

Locations

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