drugset / Trial / NCT07663526

Treatment of Chinese Adult Subjects With Moderate to Severe Crohn's Disease With Tabellvi®

NCT07663526

Phase 4 Not yet recruiting 50 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled. The primary endpoints include the incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs) and serious ADRs, as well as the proportion of subjects achieving clinical remission (CDAI score \< 150) at Week 26.

Timeline

Start
2026-08
Primary completion
2028-12
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous

Indications