A Randomized, Double-blind, Phase 3b Study to Evaluate the Short- and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn’s Disease

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509391-42-00

Acronym

Vedolizumab-3043

Enrollment

224

Registered

2025-03-10

Start date

2025-06-02

Completion date

Unknown

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chron's Disease

Brief summary

CDAI-defined clinical remission at Week 12, defined as CDAI <150, Endoscopic response at Week 12, assessed as proportion of participants achieving decrease in Simple Endoscopic Score for Crohn’s Disease (SES CD) >50% from baseline (or for participants with isolated ileal disease, SES-CD ≤4 or ≤2-point reduction from baseline) read centrally.

Detailed description

PRO2-defined clinical remission at Week 12, defined as 7-day average of very soft or liquid stool frequency ≤2.8, 7-day average of abdominal pain score ≤1.0, and neither worse than baseline, a. CDAI-defined clinical remission at Week 52. b. Endoscopic response at Week 52. c. PRO2-defined clinical remission at Week 52.

Interventions

DRUGPlacebo to Match Blinded Upadacitinib

DRUGEntyvio 300 mg powder for concentrate for solution for infusion

DRUGRINVOQ 45 mg prolonged-release tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
CDAI-defined clinical remission at Week 12, defined as CDAI <150, Endoscopic response at Week 12, assessed as proportion of participants achieving decrease in Simple Endoscopic Score for Crohn’s Disease (SES CD) >50% from baseline (or for participants with isolated ileal disease, SES-CD ≤4 or ≤2-point reduction from baseline) read centrally.	—

Secondary

Measure	Time frame
PRO2-defined clinical remission at Week 12, defined as 7-day average of very soft or liquid stool frequency ≤2.8, 7-day average of abdominal pain score ≤1.0, and neither worse than baseline, a. CDAI-defined clinical remission at Week 52. b. Endoscopic response at Week 52. c. PRO2-defined clinical remission at Week 52.	—

Countries

Austria, Belgium, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026