morf-057 vs vedolizumab

NCT05291689 · Phase 2 · completed

This was a single-group, open-label study with 39 participants overall and no placebo or active comparator. The primary clinical/histopathology endpoint was reported as a mean change, but without a comparator there was no formal between-group comparison to establish efficacy.

NCT00783718 · Phase 3 · completed

Randomized, triple-blind, placebo-controlled, adequately powered (n=895) phase 3 design with hard clinical endpoints (Mayo score-based clinical response/remission), and both primary endpoint comparisons reached statistical significance in the favorable direction (Induction: p<0.0001, RD 21.7%; Maintenance: p<0.0001 for both dose arms vs placebo) — meeting the 'strong' test.

NCT05291689 · Phase 2 · completed

This was a single-group, open-label study with 39 participants overall and no placebo or active comparator. The primary clinical/histopathology endpoint was reported as a mean change, but without a comparator there was no formal between-group comparison to establish efficacy.

NCT00783692 · Phase 3 · completed

Design is strong (randomized, triple-blind, placebo-controlled, large adequately powered N=1115, hard clinical endpoint of CDAI-based remission), but per the mixed/partially-met test in the moderate definition, one of three co-primary endpoints (induction enhanced clinical response) missed significance while the others met it, so the overall primary endpoint result is discordant/mixed rather than a clean 'met' -- good design cannot upgrade a mixed result to strong.