A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

JRCT ID: jRCT2061220065

Registered date:21/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis or Crohn's Disease
• Date of first enrollment: 13/10/2023
• Target sample size: 21
• Countries of recruitment: United States,Japan,Canada,Japan,Czechia,Japan,France,Japan,Germany,Japan,Italy,Japan,Poland,Japan,Slovakia,Japan,Spain,Japan,Israel,Japan,United Kingdom,Japan,Bulgaria,Japan,Hungary,Japan,Sweden,Japan
• Study type: Interventional
• Intervention(s): Eligible patients will be randomized (1:1:1 ratio) to receive either sc infusion of TEV-48574 (dose A), TEV-48574 (dose B) or matching placebo once every 2 weeks in a double-blind fashion.

Outcome(s)

Primary Outcome

Number of patients with moderate to severe UC who show clinical remission as defined by the Mayo score at week 14
Number of patients with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease at Week 14

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

-Diagnosis of UC or CD for >= 3 months
-Patient with moderate to severe active UC or CD
a note: Additional criteria apply

Exclude criteria

-Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis,
diverticular disease associated with colitis, or microscopic colitis.
-Patient has colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known non-passable colonic stricture, presence of colonic or small bowel stoma, presence of non-passable colonic or small bowel obstruction or resection preventing the endoscopy procedure, or fulminant colitis.
a note: Additional criteria apply

Related Information

• Primary Sponsor: Yamasaki Fumie
• Secondary ID(s): NCT05499130