Hemay007 vs infliximab-dyyb (Zymfentra)

NCT02603185 · Phase 1 · status unknown

This is a randomized, double-blind, placebo-controlled early-phase safety and pharmacokinetics study conducted in healthy volunteers rather than in patients with the target condition, with adverse-event monitoring as its primary endpoint rather than a measure of disease benefit. No results have been posted yet.

NCT04205643 · Phase 3 · completed

The trial was randomized, quadruple-blind, and placebo-controlled, with 548 participants enrolled and 438 participants included in the reported maintenance analysis. The hard clinical primary endpoint—clinical remission by the modified Mayo score at week 54—was met, with 127 of 294 participants receiving CT-P13 versus 30 of 144 receiving placebo (p<0.0001).

NCT02603185 · Phase 1 · status unknown

This is a randomized, double-blind, placebo-controlled early-phase safety and pharmacokinetics study conducted in healthy volunteers rather than in patients with the target condition, with adverse-event monitoring as its primary endpoint rather than a measure of disease benefit. No results have been posted yet.

NCT03945019 · Phase 3 · completed

This was a randomized, quadruple-blind, placebo-controlled trial with 396 participants entering induction and 343 entering the randomized maintenance comparison (231 receiving CT-P13 SC and 112 placebo). Both prespecified primary endpoints—CDAI-based clinical remission and endoscopic response at week 54—were met, with each comparison reported as p<0.0001.