Open-label Extension Study of IMR-687
Research type
Research Study
Full title
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
IRAS ID
254831
Contact name
Timothy Mant
Contact email
Sponsor organisation
Imara
Eudract number
2018-003805-25
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Summary of Research
Imara is currently studying the safety, tolerability, and exploratory pharmacodynamics (PD) of IMR-687 in a proof-of-concept study IMR-SCD-102 entitled, “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)”. In this study, patients were dosed through the end of week 24, with an end of treatment visit at week 25, and EOS follow up at week 29. To allow for patients to continue on IMR-687 at their choice after the end of study IMR-SCD-102, and to collect longer term safety data, all patients participating in study IMR-SCD-102 will be eligible for enrollment in this open-label extension study of IMR-687 (IMR-SCD-102-EXT). Patients are eligible for this open-label extension study as soon as they complete the End-of-Study visit for study IMR-SCD-102 (i.e., approximately 30 days after the last dose of study drug in the Phase 2a study). The OLE study with IMR-687 will evaluate the long-term safety and tolerability of IMR 687 in adult SCD patients. Exploratory long-term PD parameters will also be examined. A total of up to 70 patients are expected to be enrolled in the OLE study.
Summary of Results
A recently conducted Interim analysis of IMR-SCD-301 demonstrated that while IMR-687 was generally well-tolerated, it failed to meet its primary efficacy endpoint. So, the sponsor has decided to discontinue the entire Sickle Cell program, including the IMR-SCD-102-EXT study. All study information is posted to clinicaltrials.gov.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0086
Date of REC Opinion
18 Apr 2019
REC opinion
Favourable Opinion