Flexion enrolls first patients in Phase 2 trial of ZILRETTA
Flexion Therapeutics announced that the first three patients were enrolled in a clinical trial to evaluate the efficacy of ZILRETTA in patients with either shoulder osteoarthritis or adhesive capsulitis, also known as frozen shoulder. The Phase 2 double-blind, placebo-controlled, study is expected to enroll up to 250 patients - approximately 135 with shoulder OA and 115 with shoulder AC. The Phase 2 trial, known as the RANGE study, will separate cohorts of patients by their diagnosis of shoulder OA or AC into two parallel groups. Patients in each cohort will be randomized to either a single intra-articular injection of ZILRETTA or normal saline. The primary endpoint for both cohorts of the trial is the magnitude of pain relief versus placebo as measured by the overall change in daily shoulder pain with movement score from baseline to 8 weeks post injection. Patients in each cohort will be stratified by baseline pain scores. Shoulder AC patients will be further stratified by pain duration since onset and will also utilize a home exercise program during the study. Each participant will be evaluated for 24 weeks following injection. The trial is expected to complete in the first half of 2021.