An investigator-sponsored Phase II trial of Corbus Pharmaceuticals’ lenabasum has randomised 96 systemic lupus erythematosus (SLE) patients out of an expected 100, an investigator said.
Prior to the Covid-19 pandemic, the study was on pace to enrol more than the expected 100 patients, a second investigator noted. However, during the pandemic, the majority of SLE patients visiting clinic had severe or unstable SLE, and these patients are excluded from the trial, the second investigator explained.
The trial enrolled its first patient on 21 December 2017 and completion was expected in December 2020, according to its ClinicalTrials.gov page, but the trial’s record was last updated in March 2020. The study’s primary endpoint is measured at day 84.
In a 10 November 2020 press release, Corbus announced that the Phase II trial was expected to close recruitment in 1H. While the NIH’s National Institute of Allergy and Infectious Diseases is sponsoring the study, Corbus—which has a $230.3m market cap —is a collaborator along with Autoimmunity Centres of Excellence.
The trial protocol was written prior to Corbus’ involvement with the study, and Corbus supplied the drug, helped each site acquire its Schedule 1 licenses, and reviewed and made suggestions to the original protocol, the investigator said. Lenabasum is a cannabinoid receptor type 2 (CB2) agonist.
Initially, the plan was to cap enrolment of patients who exceeded a specific fibromyalgia symptom score at around 30% of the study population, the investigator noted. But an unexpectedly high number of candidates exceeding that score threshold led to dropping that constraint several years ago, the investigator added. Most of the SLE patients screened for the study did not have a co-diagnosis of fibromyalgia, but administration of the symptom scale showed that pain from fibromyalgia was more pervasive in SLE patients than treating clinicians had anticipated, the investigator explained.
The Phase II trial, which measures change from baseline in the seven-day average of the maximum daily Numerical Rating Scale (NRS) pain score as the primary endpoint, is enrolling patients with active joint disease and a baseline NRS-pain score of at least 4, according to ClinicalTrials.gov. Pain was chosen as the primary endpoint because of its ability to measure quality of life from a patient standpoint, the first investigator said.
Corbus did not respond to a request for comment. The company is also studying lenabasum in a Phase III systemic sclerosis trial, a Phase III dermatomyositis trial, and a Phase II cystic fibrosis trial in collaboration with the Cystic Fibrosis Foundation, according to the company website.
William Newton is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.