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Crohn's Disease

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Sponsored by Takeda

About this trial

Last updated 10 months ago

Study ID

Vedolizumab-3043

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started a year ago

What is this trial about?

The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn’s Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants. All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks. During the study, participants will visit their study clinic 15 times.

What are the participation requirements?

Yes

Inclusion Criteria

Men and women aged 18 to 65 years can participate in the study.
Must have been diagnosed with moderately or severely active Crohn’s Disease (CD), with CD diagnosed at least 3 months before participation in the study.
Must not be responding very well or is no longer responding to biologic therapy, therapies that suppress the immune system (corticosteroids) or increase or decrease the immune response (immunomodulators).
No

Exclusion Criteria

Cannot have ulcerative colitis or indeterminate colitis.
Cannot have a history of herpes zoster or herpes simplex.
Cannot have tuberculosis (TB).
Cannot have received an organ transplant that requires ongoing suppression of the immune system.
Cannot have had removal of bowel parts (bowel resection) within the past 3 months prior to participating in the study.
Cannot have been diagnosed with short bowel syndrome.
Must not have had any surgery with general anesthesia within 30 days prior to study participation.
Cannot have severe hepatic impairment. Additional entry criteria will be discussed with the study doctor.

Locations

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For more information, view the full study details:

NCT06227910