An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhongming Qiu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 and ≤ 75 years at screening.
Diagnosed with definite chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) according to the 2021 criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS).
CIDP Disease Activity Status (CDAS) score ≥ 2 at screening.
Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale score ≥ 2 at the initial screening.
Disqualifiers
Pure sensory atypical CIDP (as defined by EFNS/PNS).
Polyneuropathy due to other causes, including but not limited to: multifocal motor neuropathy, monoclonal gammopathy of undetermined significance with anti-myelin-associated glycoprotein (MAG) IgM antibodies, hereditary demyelinating neuropathy, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, lumbosacral radiculoplexus neuropathy, polyneuropathy most likely caused by diabetes mellitus, polyneuropathy most likely caused by systemic diseases, and drug- or toxin-induced polyneuropathy.
Any other disease that could better account for the patient's symptoms and signs.
History of any myelopathy or evidence of central demyelination.
Trial design
Design model
Single group
Treatments tested in this trial
Obinutuzumab β
DrugAdminister Obinutuzumab β Injection 600mg intravenously on W1D1, W25D1 of the treatment period
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Within 49 weeks, relapse risk is defined as a ≥1-point increase from baseline in INCAT score. The primary outcome is the proportion of patients meeting this criterion, with 95% CI.
Time frame
Within 49 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhongming Qiu
Lead sponsor
Xinqiao Hospital of Chongqing
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: