October, 10 2019

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

1 United States site

Age

> 18 Years

Genotypes

SS

Phase

Phase 2

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.

Study Type

Interventional

Phase

Phase 2

Age

> 18 Years

Genotype

SS

Gender

All

Inclusion Criteria

1. Must have been previously enrolled in the IMR-687 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)”, i.e., Study
IMR-SCD-102.

2. Female subjects must not be pregnant and be highly unlike to become pregnant. Male
subjects must be unlikely to impregnate their 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 at screening >12.5 g/dL or <6 g/dL 2. Subjects who test positive for human immunodeficiency virus (HIV), hepatitis C (HCV) antibodies (unless the patient has successfully completed drug therapy that results in cure/clearance of HCV), and hepatitis B surface antigen (HBsAg) 3. Female subjects who test positive for a serum pregnancy test at screening or a urine pregnancy test at Day 1 4. eGFR <50 mL/min 5. AST/ALT > 3x the upper limit of normal

Interventions

  • Drug

Outcome measures

  • Proportion of patients with adverse events and serious adverse events
  • Proportion of patients with changes in clinical laboratory tests
  • Proportion of patients with changes in safety cardiac parameters
  • Proportion of patients with clinically significant abnormal vital signs

Location

  • Foundation for Sickle Cell Disease Research, Hollywood, Florida, United States, 33021

More info

View on ClinicalTrials
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