drugset / Trial / NCT07696377

An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy

NCT07696377 ↗

Phase 1/2 Not yet recruiting 24 enrolled Zhongming Qiu
NaSingle-groupOpen-labelTreatment

Summary

This clinical trial aims to evaluate the safety and efficacy of obinutuzumab β in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The key research objectives are as follows:1. To assess the efficacy of obinutuzumab β for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy.2. To assess the safety of obinutuzumab β for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy.Study participants are required to:Receive two intravenous infusions of obinutuzumab β.Attend follow-up examinations and laboratory tests at the study site at Week 1, Week5, Week9, Week 13, Week 25, Week 37, Week 49, Week 61, Week 73.Maintain a daily symptom diary and record the number of rescue treatments.

Timeline

Start
2026-07-15
Primary completion
2030-01-30
Completion
2031-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Obinutuzumab β Monoclonal antibody 600 mg Intravenous