Clinical Study Report Synopsis (OBX-319)
๐ Part of the OBX-319 Regulatory Dossier โ Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing โ the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. Clinical Study Report Synopsis (OBX-319)
Why it exists. Clinical study documentation supporting the efficacy and safety of the program.
How it is produced here. The numbers come straight from the study's simulated Phase 3 dataset โ they are calculated from the data, not typed in by hand. That is why you see the same figures repeated across the protocol, the analysis plan, the report, and the summaries: they all read from the same source.
Format & governing standard. โ
Clinical Study Report Synopsis (OBX-319)
Document ID: CSR-301
Version: 1.0
Change History: 1.0 โ 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 ฮ 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 | โ (reference) | โ |
Responder analysis โ 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% | โ (reference) | โ |
Safety results
| Arm | N | โฅ1 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.
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