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
Qualifiers
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
Treatments tested in this trial
- Obinutuzumab β
Treatment groups
24 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Zhongming Qiu
Lead sponsor
Xinqiao Hospital of Chongqing
Sponsor institution
Source ClinicalTrials.gov