Triple Combination Therapy in High Risk Crohn's Disease (CD)

• Status: Active, not recruiting
• Trial end date: 2022-07-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Adalimumab; Methotrexate; Vedolizumab

Criteria

Inclusion Criteria:

1. Has an initial diagnosis of CD established within 24 months prior to screening with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.

2. Has moderate to severely active CD during Screening defined by a centrally assessed simple endoscopic score for Crohn disease (SES-CD) score >=7 (or >=4 if isolated ileal disease).

Exclusion Criteria:

Gastrointestinal (GI) Exclusion Criteria

1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.

2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal abscess.

3. Has a known perianal fistula with abscess. (The participant may have a perianal fistula without abscess.)

4. Has a known fistula (other than perianal fistula).