An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating Pol… (NCT07696377) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy
24 participantsStarted 2026-07-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Voluntarily sign the informed consent form.
. Female participants of childbearing potential must have a negative pregnancy test (serum β-HCG)at screening .Effective contraception shall be used during the study period and for 12 months after the last dose. Male participants and their partners must also agree to use effective contraception.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
. 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.
. Current or history of alcohol, drug, or substance abuse within 12 months prior to screening.
. Severe psychiatric disorders (e.g., major depressive disorder, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that, in the opinion of the investigator, may place the patient at undue risk or interfere with the patient's compliance with the study protocol.
. Any uncontrolled active infection or serious infection within 8 weeks prior to screening; clinically significant active or chronic uncontrolled bacterial, viral, or fungal infections, including patients with active viral infection detected at screening: active hepatitis B virus (as indicated by serological tests showing active \[acute or chronic\] infection), active hepatitis C virus (positive HCV-Ab serology), or human immunodeficiency virus (HIV)-positive serology associated with acquired immunodeficiency syndrome (AIDS)-defining conditions or with a CD4 count ≤ 200 cells/mm³.
. Total immunoglobulin G (IgG) level \< 6 g/L at screening.