Summary

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

Description

Summary

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).

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, ages 18 to 55 years old, to examine the safety, tolerability, and PK, as well as the potential PD effects and clinical efficacy, of IMR-687 across a range of doses.

Keywords

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

Eligibility

You can join if…

Open to people ages 18-55

  • Male or female patients with confirmed SCA
  • 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
    Oakland California 94609 United States
  • Baylor Scott & White Health
    Temple Texas 76508 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Imara, Inc.
ID
NCT03401112
Phase
Phase 2
Study Type
Interventional
Last Updated