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

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Vedolizumab — DRUG
  Vedolizumab IV infusion.
• Upadacitinib — DRUG
  Upadacitinib over-encapsulated tablets.
• Placebo — DRUG
  Upadacitinib matched placebo capsules.

Study Details

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.

Key Dates

Start date

Jan 2, 2025

Status verified

May 2026

Primary completion

Jun 8, 2027

Completion

Aug 1, 2028

Study Design

Enrollment

396 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Double-blind Induction Phase: Vedolizumab + Upadacitinib
  Participants will receive vedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, 6 and 10 along with upadacitinib 45 mg, orally, once daily (QD) for 12 weeks.
• Placebo Comparator: Double-blind Induction Phase: Vedolizumab + Placebo
  Participants will receive vedolizumab IV 300 mg infusion, at Weeks 0, 2, 6 and 10 along with upadacitinib matched placebo, orally, QD for 12 weeks.
• Experimental: Main Study Maintenance Phase: Vedolizumab Monotherapy
  Participants who achieve a CDAI reduction of \>=70 points from baseline at Week 12 will receive vedolizumab 300 mg IV infusion (monotherapy), every 8 weeks (Q8W) starting at Week 14 to 52. The Q8W vedolizumab monotherapy may be escalated to Q4W at the investigator's discretion.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12 [ Time Frame: Week 12 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (19)

Find similar trials in La Jolla, CA

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