Celltrion (KRX:068270) said it submitted an amendment to the Phase 3 clinical trial protocol for CT-P44, a biosimilar candidate for Darzalex, to South Korea's Ministry of Food and Drug Safety.
The trials will evaluate the efficacy and safety of CT-P44 against Darzalex Faspro in patients with relapsed or refractory multiple myeloma, according to a Tuesday filing with the Korea Exchange.
The amendment is filed to adjust the number of trial participants following a change in its regulatory strategy, and the randomized, double-blind trial is expected to involve 394 participants and run for two years.