Vedolizumab-4051

Recruiting

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

Clinicaltrials.gov

Other

#MACS-2022-120102

Other

#EXPLORER 2.0

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab together with ustekinumab 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.

Interventional Phase 4 clinical trial.

What medical conditions are being studied?

Crohn's Disease

What is the clinical trial testing?

Vedolizumab, Adalimumab, Ustekinumab

How many participants are being enrolled?

150

Are placebos part of the clinical trial?

When is the clinical trial being conducted?

Apr 2024 - Jun 2027

How long is participation in the clinical trial?

Participants will be in this study for up to 76 weeks.

Sexes

All

Age

18 to 65 Years

Healthy volunteers?

Men and women aged 18 to 65 years can participate in the study.

Must have Crohn’s Disease for at least 3 months before the study.

Must not have been responding properly to earlier treatment with ustekinumab, risankizumab, infliximab (or biosimilar), adalimumab or certolizumab pegol.

Cannot have short bowel syndrome, ulcerative colitis, an abscess in the belly (abdominal abscess) or fistula in the anus (perianal fistula) with abscess.

Cannot have parts of their bowels removed (colon resection) within 6 months of study participation

Cannot have had a stomach (gastric) bypass surgery.

Cannot have any organ transplantation.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

Part A: Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 26 [Time Frame: Week 26]

Part B: Percentage of Participants in Clinical Remission Based on the CDAI at Week 52 [Time Frame: Week 52]

Secondary outcome measures

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

Percentage of Participants Achieving 2-item Patient-reported Outcome Measure (PRO2) Remission at Weeks 12, 26, and 52 [Time Frame: Weeks 12, 26 and 52]

Change in PRO2 Score from Week 26 to 52 [Time Frame: Weeks 26 and 52]

Percentage of Participants with Stool Frequency Remission at Weeks 12, 26, and 52 [Time Frame: Weeks 12, 26, and 52]

Percentage of Participants with Abdominal Pain Remission at Weeks 12, 26, and 52 [Time Frame: Weeks 12, 26, and 52]

Percentage of Participants Achieving Endoscopic Remission Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Weeks 26 and 52 [Time Frame: Weeks 26 and 52]

Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Both Weeks 26 and 52 [Time Frame: Weeks 26 and 52]

Percentage of Participants Exhibiting an Endoscopic Response Based on SES-CD at Weeks 26 and 52 [Time Frame: Weeks 26 and 52]

Percentage of Participants in Deep Remission Based on the CDAI and SES-CD at Weeks 26 and 52 [Time Frame: Weeks 26 and 52]

Percentage of Participants in Deep Remission Based on the CDAI and SES-CD at Both Weeks 26 and 52 [Time Frame: Weeks 26 and 52]

Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Weeks 12, 26, and 52 [Time Frame: Weeks 12, 26, and 52]

Percentage of Participants Using Oral Corticosteroids at Baseline who have Discontinued Corticosteroids and are in Clinical Remission Based on the CDAI [Time Frame: Week 30 through Week 64]

Percentage of Participants Achieving Complete Endoscopic Healing Based on SES-CD at Weeks 26 and 52 [Time Frame: Weeks 26 and 52]

Change in SES-CD from Baseline to Weeks 26 and 52 [Time Frame: Baseline, Weeks 26 and 52]

Percentage of Participants with First CD Exacerbation After 26 Weeks [Time Frame: Week 26 through Week 52]

Change in FCP Concentrations from Baseline to Weeks 12, 26, 42, and 52 [Time Frame: Baseline, Weeks 12, 26, 42, and 52]