A Study to Compare the Efficacy and Safety of Vedolizumab With and Without Upadacitinib in Adults With Moderately to Severely Active Crohn's Disease (VICTRIVA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Takeda Development Center Americas Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

2 Jun 2025 → ongoing

Decision date (initial)

2025-03-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Takeda Development Center Americas, Inc.

External identifiers

EU CT number

2023-509391-42-00

ClinicalTrials.gov

NCT06227910

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To evaluate whether DTT (vedolizumab and upadacitinib) during induction improves clinical and endoscopic outcomes by Week 12, compared with vedolizumab monotherapy, in participants with moderately to severely active CD.

Secondary objectives 2

1. To evaluate further the short-term clinical and endoscopic benefits of DTT during induction, compared with vedolizumab monotherapy, in participants with moderately to severely active CD.
2. To evaluate the efficacy of vedolizumab maintenance therapy after DTT during induction, compared with vedolizumab monotherapy throughout the study, in participants with moderately to severely active CD.

Conditions and MedDRA coding

Chron's Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report.
2. The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.
3. The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score of ≥6 (or ≥4 for participants with isolated ileal disease), as confirmed by a central reader.
4. The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.

Exclusion criteria 8

1. The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
2. The participant has infection(s) requiring treatment with IV anti-infectives within 30 days before baseline or oral/intramuscular anti-infectives within 14 days before baseline.
3. The participant has evidence of an active infection during the screening period, or clinically significant infection (for example, pneumonia or pyelonephritis) within 30 days prior to screening, or ongoing chronic infection.
4. The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
5. The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study.
6. The participant has an ostomy or ileoanal pouch.
7. The participant has severe renal impairment, defined as an estimated glomerular filtration rate of <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2).
8. The participant has severe (Child-Pugh C) hepatic impairment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. CDAI-defined clinical remission at Week 12, defined as CDAI <150
2. Endoscopic response at Week 12, defined as a 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 a ≥ 2-point reduction in SES-CD from baseline) read centrally.

Secondary endpoints 2

1. 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
2. a. CDAI-defined clinical remission at Week 52. b. Endoscopic response at Week 52. c. PRO2-defined clinical remission at Week 52.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Takeda Development Center Americas Inc.

Sponsor organisation

Takeda Development Center Americas Inc.

Address

500 Kendall Street

City

Cambridge

Postcode

02142-1108

Country

United States

Scientific contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Pooja Oberai

Public contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Takeda

Third parties 8

Locations

18 EU/EEA countries · 92 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 371 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications