Samples / TILA-278

TILA-278 — Ulcerative Colitis (moderate-to-severe)

Drug
TILA-278
Modality
anti-TL1A / IL-22 agonist bispecific antibody
Indication
Ulcerative Colitis (moderate-to-severe)
Phase
2
Protocol
TILA278-201
Design
randomized, double-blind, placebo-controlled
Randomized
900
Primary endpoint
Clinical remission (modified Mayo) at Week 12
Arms
TILA-278 High · TILA-278 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 TILA-278 High284Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +45
LS-mean change TILA-278 High-3.36Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
diff vs placebo TILA-278 High-2.36Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
diff CI low TILA-278 High-2.49Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
diff CI high TILA-278 High-2.23Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
FAS N TILA-278 Low283Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +45
LS-mean change TILA-278 Low-2.76Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
diff vs placebo TILA-278 Low-1.77Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
diff CI low TILA-278 Low-1.90Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
diff CI high TILA-278 Low-1.64Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
FAS N Placebo273Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +45
LS-mean change Placebo-1.00Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
remitters TILA-278 High106/284Project Charter (TILA-278), Governance & RACI (TILA-278), Vendor / CRO Management (TILA-278) +36
remission rate TILA-278 High37.3Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +47
risk diff TILA-278 High36.6Clinical Development Plan (TILA-278), Module 1 (EU) — Summary of Product Characteristics (TILA-278), End-of-Phase-2 Briefing Book (TILA-278) +13
remitters TILA-278 Low46/283Project Charter (TILA-278), Governance & RACI (TILA-278), Vendor / CRO Management (TILA-278) +36
remission rate TILA-278 Low16.2Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +48
risk diff TILA-278 Low15.5Clinical Development Plan (TILA-278), Module 1 (EU) — Summary of Product Characteristics (TILA-278), End-of-Phase-2 Briefing Book (TILA-278) +13
remitters Placebo2/273Project Charter (TILA-278), Governance & RACI (TILA-278), Vendor / CRO Management (TILA-278) +36
remission rate Placebo0.7Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +47
randomized N Placebo301Project Charter (TILA-278), Program Budget & Cost Model (TILA-278), Vendor / CRO Management (TILA-278) +43
randomized N TILA-278 Low300Project Charter (TILA-278), Program Budget & Cost Model (TILA-278), Vendor / CRO Management (TILA-278) +51
randomized N TILA-278 High299Project Charter (TILA-278), Program Budget & Cost Model (TILA-278), Vendor / CRO Management (TILA-278) +45
[label M1-EU_SmPC.md] LS-mean change TILA-278 High-3.36Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
[label M1-EU_SmPC.md] LS-mean change TILA-278 Low-2.76Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
[label M1-EU_SmPC.md] remission rate TILA-278 High37.3Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +47
[label M1-EU_SmPC.md] remission rate TILA-278 Low16.2Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +48
[label M1-US_admin_and_USPI.md] LS-mean change TILA-278 High-3.36Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
[label M1-US_admin_and_USPI.md] LS-mean change TILA-278 Low-2.76Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
[label M1-US_admin_and_USPI.md] remission rate TILA-278 High37.3Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +47
[label M1-US_admin_and_USPI.md] remission rate TILA-278 Low16.2Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +48
[label M1-KR_admin_and_label.md] LS-mean change TILA-278 High-3.36Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
[label M1-KR_admin_and_label.md] LS-mean change TILA-278 Low-2.76Module 1 (EU) — Summary of Product Characteristics (TILA-278), Module 1 (KR) — Administrative & Label (TILA-278), Module 2.5.6 — Benefit–Risk Assessment (TILA-278) +5
[label M1-KR_admin_and_label.md] remission rate TILA-278 High37.3Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +47
[label M1-KR_admin_and_label.md] remission rate TILA-278 Low16.2Project Charter (TILA-278), Governance & RACI (TILA-278), Program Budget & Cost Model (TILA-278) +48

Dossier (98 documents)

program-management

quality

regulatory/m1

regulatory/m2

regulatory/m3-quality

regulatory/m4-nonclinical

regulatory/m5-clinical

tmf