Summary

for people ages 18-55 (full criteria)
at Oakland, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

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)

Details

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.

Keywords

Sickle Cell Disease Anemia, Sickle Cell Thalassemia IMR-687 PBO Dose 1 Dose 2

Eligibility

You can join if…

Open to people ages 18-55

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Benioff Children's Hospital Oakland accepting new patients
    Oakland California 94609 United States
  • Loretto Hospital accepting new patients
    Chicago Illinois 60644 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Imara, Inc.
ID
NCT03401112
Phase
Phase 2
Study Type
Interventional
Last Updated