A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

Conditions

• Crohn's Disease
• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Vedolizumab IV — DRUG
  Vedolizumab IV infusion
• Vedolizumab SC — DRUG
  Vedolizumab SC injection

Study Details

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.

Key Dates

Start date

Mar 27, 2025

Status verified

Jun 2026

Primary completion

Oct 1, 2027

Completion

Jun 1, 2028

Study Design

Enrollment

400 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: UC Participants: Vedolizumab
  Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
• Experimental: CD Participants: Vedolizumab
  Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.

Primary Outcome Measure

Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14 [ Time Frame: At Week 14 ]

Central Contacts

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

Locations (100)

Find similar trials in Birmingham, AL

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