Samples / OBX-319

OBX-319 — Systemic Lupus Erythematosus (moderate-to-severe active)

Drug
OBX-319
Modality
anti-CD19 x anti-CD20 B-cell-depleting bispecific antibody
Indication
Systemic Lupus Erythematosus (moderate-to-severe active)
Phase
3
Protocol
OBX319-301
Design
randomized, double-blind, placebo-controlled
Randomized
480
Primary endpoint
SRI-4 response at Week 52 (operationalised as low disease activity, SLEDAI-2K <= 4)
Arms
OBX-319 High · OBX-319 Low · Placebo

From study definition to dossier

One study.yaml drives every step; the dossier engine regenerates all of it from source.

1 · Study definitionstudy.yaml
2 · Simulated raw data6 files
3 · SDTMAE, DM, LB, VS
4 · ADaMADAE, ADLB, ADSL, ADTTE, ADVS
5 · Analysis outputs2 tables
6 · CTD dossier98 documents

Numbers the gate traced

The engine's reconciliation gate recomputed these 35 values from the analysis outputs and found each one in the dossier text. Re-run at build time; a mismatch stops the build.

ValueNumberStated in
FAS N OBX-319 High145Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +26
LS-mean change OBX-319 High-6.37Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +18
diff vs placebo OBX-319 High-2.91Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +17
diff CI low OBX-319 High-3.12Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +11
diff CI high OBX-319 High-2.69Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +11
FAS N OBX-319 Low145Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +26
LS-mean change OBX-319 Low-5.62Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +18
diff vs placebo OBX-319 Low-2.17Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +17
diff CI low OBX-319 Low-2.38Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +11
diff CI high OBX-319 Low-1.95Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +11
FAS N Placebo150Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +33
LS-mean change Placebo-3.46Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +18
remitters OBX-319 High76/145Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
remission rate OBX-319 High52.4Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
risk diff OBX-319 High46.4Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Administrative & US Prescribing Information (OBX-319) +8
remitters OBX-319 Low49/145Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
remission rate OBX-319 Low33.8Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
risk diff OBX-319 Low27.8Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Administrative & US Prescribing Information (OBX-319) +8
remitters Placebo9/150Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
remission rate Placebo6.0Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +25
randomized N OBX-319 High162Clinical Development Plan (OBX-319), Quality Management Plan (OBX319-301), Module 1 (EU) — IMPD Summary (OBX-319) +32
randomized N Placebo160Clinical Development Plan (OBX-319), Quality Management Plan (OBX319-301), Module 1 (EU) — IMPD Summary (OBX-319) +34
randomized N OBX-319 Low158Clinical Development Plan (OBX-319), Quality Management Plan (OBX319-301), Module 1 (EU) — IMPD Summary (OBX-319) +32
[label M1-EU_SmPC.md] LS-mean change OBX-319 High-6.37Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +18
[label M1-EU_SmPC.md] LS-mean change OBX-319 Low-5.62Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +18
[label M1-EU_SmPC.md] remission rate OBX-319 High52.4Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
[label M1-EU_SmPC.md] remission rate OBX-319 Low33.8Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
[label M1-US_admin_and_USPI.md] LS-mean change OBX-319 High-6.37Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +18
[label M1-US_admin_and_USPI.md] LS-mean change OBX-319 Low-5.62Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +18
[label M1-US_admin_and_USPI.md] remission rate OBX-319 High52.4Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
[label M1-US_admin_and_USPI.md] remission rate OBX-319 Low33.8Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
[label M1-KR_admin_and_label.md] LS-mean change OBX-319 High-6.37Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +18
[label M1-KR_admin_and_label.md] LS-mean change OBX-319 Low-5.62Clinical Development Plan (OBX-319), Module 1 (EU) — Summary of Product Characteristics (OBX-319), Module 1 (US) — Application Summary (OBX-319) +18
[label M1-KR_admin_and_label.md] remission rate OBX-319 High52.4Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24
[label M1-KR_admin_and_label.md] remission rate OBX-319 Low33.8Program Risk Register (OBX-319), Clinical Development Plan (OBX-319), Module 1 (EU) — IMPD Summary (OBX-319) +24

Dossier (98 documents)

program-management

quality

regulatory/m1

regulatory/m2

regulatory/m3-quality

regulatory/m4-nonclinical

regulatory/m5-clinical

tmf