A Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)

Status:	Recruiting
Conditions:	Anemia, Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	18 - 55
Updated:	1/18/2019
Start Date:	January 26, 2018
End Date:	June 2019
Contact:	ShiYin Foo, MD PhD MMSc
Email:	syfoo@imaratx.com
Phone:	+1617-231-6721

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)

A Phase 2a randomized, placebo-controlled, multicenter study of orally administered IMR-687
in adults with Sickle Cell Anaemia (SCA).

This is a proof of concept study in adult SCA patients, age 18-55 years old. The primary goal
is to examine the safety, pharmacokinetics and preliminary pharmacodynamics of escalating
doses of IMR-687 as compared to placebo.

Inclusion Criteria:

- Male or female patients with confirmed SCD

- Age 18-55 years, inclusive

- For patients on hydroxyurea, must have been on a stable dose for at least 60 days
prior to screening

Exclusion Criteria:

- Total hemoglobin >12.5 or less than 6 g/dL

- RBC transfusion within 60 days of baseline

- >7 hospitalizations for vasoocclusive crises within the last year

- eGFR < 50 ml/min

- AST/ALT > 3x the upper limit of normal

We found this trial at

sites

East Carolina University

1001 E 5th St
Greenville, North Carolina 27858

(252) 328-6131