Module 2.7.6 — Synopses of Individual Studies (OBX-319)
Document ID: M276
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH M4E(R2)
2.7.6 Synopses of Individual Studies — OBX-319
Structured synopses of each study in the OBX-319 programme. The pivotal study OBX319-301 (randomized, double-blind, placebo-controlled, Phase 3) is summarised below; full synopses appear in the corresponding Module 5 study reports.
| Arm | N | LS-mean Δ SLEDAI-2K @ Wk 52 (points) | Diff vs placebo (95% CI) | p |
|---|---|---|---|---|
| OBX-319 High | 162 | -6.37 | -2.91 (-3.12, -2.69) | 0.0000 |
| OBX-319 Low | 158 | -5.62 | -2.17 (-2.38, -1.95) | 0.0000 |
| Placebo | 160 | -3.46 | — (reference) | — |