Celltrion Submits Phase 4 Trial Plan for Zymfentra

Celltrion has submitted an IND application to the US FDA for a Phase 4 trial to evaluate a high-dose 240 mg regimen of Zymfentra (Remsima SC) targeting autoimmune diseases like Crohn’s and ulcerative colitis, aiming to provide evidence for long-term safety and efficacy. The trial will involve 447 patients in 55 US sites, comparing the high-dose intravenous treatment with the subcutaneous version.

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