Clinical Study Report Synopsis (OBX-319)
Document ID: CSR-301
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH E3
Synopsis
- Compound: OBX-319
- Indication: Systemic Lupus Erythematosus (moderate-to-severe active)
- Phase: 3
- Design: randomized, double-blind, placebo-controlled, allocation 1:1:1, N randomized 480
- Primary endpoint: SRI-4 response at Week 52 (operationalised as low disease activity, SLEDAI-2K <= 4)
Efficacy results
| 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) | — |
Responder analysis — Low disease activity (SLEDAI-2K <= 4)
| Arm | N | Responders, n/N | Rate | Risk diff vs placebo (95% CI, %) | p |
|---|---|---|---|---|---|
| OBX-319 High | 145 | 76/145 | 52.4% | 46.4% (37.4, 55.4) | 0.0000 |
| OBX-319 Low | 145 | 49/145 | 33.8% | 27.8% (19.2, 36.4) | 0.0000 |
| Placebo | 150 | 9/150 | 6.0% | — (reference) | — |
Safety results
| Arm | N | ≥1 TEAE | SAE | Deaths | Discontinued |
|---|---|---|---|---|---|
| OBX-319 High | 162 | 78 | 2 | 1 | 17 |
| OBX-319 Low | 158 | 74 | 1 | 0 | 13 |
| Placebo | 160 | 78 | 1 | 0 | 10 |
Most frequent adverse events (subjects, by arm)
| Preferred term | OBX-319 High | OBX-319 Low | Placebo |
|---|---|---|---|
| Upper respiratory tract infection | 25 | 18 | 13 |
| Urinary tract infection | 16 | 14 | 14 |
| Nasopharyngitis | 11 | 14 | 16 |
| Headache | 11 | 11 | 16 |
| Lupus nephritis flare | 4 | 8 | 16 |
| Injection site reaction | 14 | 7 | 6 |
Conclusion
OBX-319 demonstrated a dose-ordered, statistically significant and clinically meaningful effect on SLEDAI-2K versus placebo, with an acceptable and well-characterised safety profile over the 52-week induction period.