Observational Long-Term Safety of Participants from Corbus Pivotal CT
Research type
Research Study
Full title
An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials
IRAS ID
286088
Contact name
Patrick Gordon
Contact email
Sponsor organisation
Corbus Pharmaceuticals, Inc.
Eudract number
2020-001762-11
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Corbus Pharmaceuticals, Inc., is developing the novel synthetic selective oral agonist of cannabinoid receptor type 2 (CB2), lenabasum, for the treatment of several chronic inflammatory and fibrotic diseases. Multiple nonclinical pharmacology studies have demonstrated that lenabasum activates resolution of innate immune responses. The clinical efficacy and safety of lenabasum for the treatment of cystic fibrosis (CF), dermatomyositis (DM), and systemic sclerosis (SSc) is currently being evaluated in 3 Phase 2/3 studies.
The goal of this observational safety study is to collect the long-term safety data from subjects who received study treatment (lenabasum or placebo) in a Corbus sponsored essential clinical trials. Participating subjects will be assessed (by telephone or office visit) approximately every 6 ±1 month for AEs (adverse events) for the duration of 2 years from the subject’s last safety visit in a qualifying Corbus lenabasum clinical trial, unless Corbus discontinues the lenabasum development program.
It is not known if AEs associated with class effects of CB1/CB2 agonists might emerge several months after treatment lenabasum is discontinued. Thus, this study was designed to assess potential late-emerging AEs (such as psychiatric or other events) biannually, for the duration of two years, after discontinuation of lenabasum treatment.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0216
Date of REC Opinion
17 Sep 2020
REC opinion
Unfavourable Opinion