An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT07696377 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-07-10
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.
Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Obinutuzumab β
Interventions
- DRUG
-
Obinutuzumab β
Administer Obinutuzumab β Injection 600mg intravenously on W1D1, W25D1 of the treatment period
Sponsors & Collaborators
-
Zhongming Qiu
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-15
- Primary Completion
- 2030-01-30
- Completion
- 2031-02-28
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