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

A Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study (RELIEVE UCCD LTE)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061230004

Enrollment

Registered

2023-04-11

Start date

2024-04-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis or Crohn's Disease

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Austria, Belguim, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Poland, Slovakia, Spain, United Kingdom, United States

Contacts

Public ContactTaiki Maeda

CMIC Co., Ltd.

ClinicalTrialInformation@cmic.co.jp+81-3-6779-8000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026