Clinical Research Studies

CC-93538 is a recombinant humanized, high-affinity neutralizing (immunoglobulin G1 kappa [IgG1?]) monoclonal antibody (mAb) selective for interleukin-13 (IL-13). CC-93538 binds to IL-13, thus preventing its interaction with both IL-13 receptors, IL-13 receptor alpha 1 (IL-13Ra1) and IL-13 receptor alpha 2 (IL-13Ra2). Eosinophilic esophagitis (EoE) is a chronic immune/antigen-mediated esophageal disease characterized clinically by symptoms related to esophageal dysfunction and histologically by eosinophil-predominant inflammation, and IL-13 has been shown to be a key driver of disease pathology in patients with EoE. The Phase 3 program includes a multi-center, multi-national, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC-93538 in adult and adolescent subjects with EoE (Study CC-93538-EE-001) with a separate, optional Open-Label Extension Study (OLE; Study CC-93538-EE-002). Results of the Phase 2 Study, RPC02-201, in adult subjects with EoE showed that administration of CC-93538 180 mg and 360 mg subcutaneously (SC) weekly for 16 weeks reduced the mean esophageal eosinophil count (the primary endpoint) and improved other inflammatory parameters. A greater reduction in dysphagia symptoms was observed with the 360 mg dose although it did not reach statistical significance. The study also demonstrated the safety and tolerability of CC-93538 in adult subjects with symptomatic EoE treated with one of two dose levels (CC-93538 180 mg or 360 mg SC) compared to placebo. CC-93538 was generally safe and well-tolerated for up to 68 weeks of treatment (including data from a 52-week CC-93538 Open-Label Extension). These data support the continued development of CC-93538 as a novel treatment for EoE. The single pivotal Phase 3 study is designed to confirm and extend the findings obtained from the positive Phase 2 study with CC-93538.