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

• Status: Completed
• Trial end date: 2020-08-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imara, Inc.

Criteria

Inclusion Criteria:

• 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

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