A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Vedolizumab — DRUG
  Vedolizumab intravenous infusion.
• Adalimumab — DRUG
  Adalimumab subcutaneous injection.
• Ustekinumab — DRUG
  Ustekinumab intravenous infusion.
• Ustekinumab — DRUG
  Ustekinumab subcutaneous injection.

Study Details

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.

Key Dates

Start date

Apr 18, 2024

Status verified

Mar 2026

Primary completion

Jun 28, 2027

Completion

Jun 28, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A, Cohort 1: Vedolizumab + Adalimumab
  Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then every 8 weeks (Q8W) until Week 22 and adalimumab SC 160, 80, and 40 mg at Weeks 0, 2, and 4, respectively, then 40 mg every 2 weeks (Q2W) until Week 26.
• Experimental: Part A, Cohort 2: Vedolizumab + Ustekinumab
  Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then Q8W until Week 22 and ustekinumab IV 520, 390, or 260 mg (weight-based), then SC 90 mg 8 weeks after initial IV dose, then Q8W until Week 24.
• Experimental: Part B: Vedolizumab Monotherapy
  Participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy, Q8W from Week 30 until Week 46 and will be followed up to Week 52.

Primary Outcome Measure

Part A: Percentage of Participants With an Endoscopic Response Based on the Simple Endoscopic Score for (SES-CD) at Week 26 [ Time Frame: At Week 26 ]

Central Contacts

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

Locations (45)

Find similar trials in Dothan, AL

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