Module 2.7.6 — Synopses of Individual Studies (TILA-278)
Document ID: M276
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH M4E(R2)
2.7.6 Synopses of Individual Studies — TILA-278
Structured synopses of each study in the TILA-278 programme. The pivotal study TILA278-201 (randomized, double-blind, placebo-controlled, Phase 2) is summarised below; full synopses appear in the corresponding Module 5 study reports.
| Arm | N | LS-mean Δ Modified Mayo Score @ Wk 12 (points) | Diff vs placebo (95% CI) | p |
|---|---|---|---|---|
| TILA-278 High | 299 | -3.36 | -2.36 (-2.49, -2.23) | 0.0000 |
| TILA-278 Low | 300 | -2.76 | -1.77 (-1.90, -1.64) | 0.0000 |
| Placebo | 301 | -1.00 | — (reference) | — |