afimkibart vs duvakitug

NCT04090411 · Phase 2 · completed

This was a randomized, double-blind, placebo-controlled Phase 2 study (N=246) in moderate-to-severe ulcerative colitis, with Week 14 clinical remission on the Mayo score as the primary endpoint. Although remission rates were numerically higher in all afimkibart dose groups (25.5%, 23.3%, 23.9%) than placebo (11.6%), the differences were not statistically significant (one-sided p-values 0.055–0.082; 90% confidence intervals crossed zero), so the primary efficacy comparison was not met. The well-controlled design is real evidence, but because the primary endpoint was missed, the trial does not rise to strong evidence of benefit.

NCT05499130 · Phase 2b · completed

Randomized, double-blind, placebo-controlled, with the high dose reaching significance (p=.003) and replicating in a Crohn's disease cohort. The low dose was only borderline (p=.050) and the sample size per arm was modest. A well-designed trial with a partial, dose-dependent result is capped at moderate rather than strong. Progressed to Phase 3.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

No graded featured trial for this indication yet; the grade above reflects that absence, not a judgment.

NCT05499130 · Phase 2b · completed

Randomized, double-blind, placebo-controlled, with the high dose reaching significance (p=.003) and replicating in a Crohn's disease cohort. The low dose was only borderline (p=.050) and the sample size per arm was modest. A well-designed trial with a partial, dose-dependent result is capped at moderate rather than strong. Progressed to Phase 3.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.