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

JRCT ID: jRCT2061230004

Registered date:11/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis or Crohn's Disease
• Date of first enrollment: 05/04/2024
• Target sample size: 11
• 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,Austria,Japan,Belguim,Japan
• Study type: Interventional

Intervention(s)

- TEV-48574(dose regimmen A)
- TEV-48574(dose regimen B)

Outcome(s)

Primary Outcome

Number of patients with moderate to severe UC who show clinical remission as defined by the Mayo score at week 44
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 44

Key inclusion & exclusion criteria

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

Include criteria

- Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study.
- Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study
a note: Additional criteria apply

Exclude criteria

-Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons) and participants who didn't meet the definition of clinical response or clinical remission based on their DRF week 14 assessment.
-Participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician.
a note: Additional criteria apply

Related Information

• Primary Sponsor: Yamasaki Fumie
• Secondary ID(s): NCT05668013