Experimental drug aims to tame rare nerve disorder
NCT ID NCT07696377
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This trial tests a drug called obinutuzumab β in people with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a condition where the immune system attacks nerves, causing weakness and numbness. Participants receive two intravenous infusions of the drug and are monitored for about 73 weeks to see if it reduces relapses. The goal is to find a safer and more effective way to control this rare nerve disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- obinutuzumab β
- What this could lead to
- If successful, this could provide a new treatment option for people with CIDP, potentially reducing relapses and the need for rescue therapies.
- What could go wrong
- This is a small, early-phase trial (Phase 1/2) with only 24 participants, so results may not apply broadly. The drug may cause side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged ≥ 18 and ≤ 75 years at screening. 2. 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). 3. CIDP Disease Activity Status (CDAS) score ≥ 2 at screening. 4. Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale score ≥ 2 at the initial screening. 5. Voluntarily sign the informed consent form. 6. 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. Exclusion Criteria: 1. Pure sensory atypical CIDP (as defined by EFNS/PNS). 2. 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. 3. Any other disease that could better account for the patient's symptoms and signs. 4. History of any myelopathy or evidence of central demyelination. 5. Current or history of alcohol, drug, or substance abuse within 12 months prior to screening. 6. 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. 7. 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. 8. Total immunoglobulin G (IgG) level \< 6 g/L at screening. 9. Received the following treatments within 6 months prior to screening: any other investigational drug; any anti-CD20 monoclonal antibody or other biologic agents (e.g., rituximab); alemtuzumab; any other monoclonal antibody; cyclophosphamide; interferon; tumor necrosis factor-α inhibitors; fingolimod; methotrexate; azathioprine; mycophenolate mofetil; any other immunomodulatory or immunosuppressive drugs; and oral corticosteroids \> 10 mg/day. 10. Presence of any other known autoimmune disease that, in the investigator's opinion, may interfere with the accurate assessment of CIDP clinical symptoms. 11. Receipt of live-attenuated vaccine within 1 month prior to screening (patients who have received inactivated, subunit, polysaccharide, or conjugate vaccines at any time prior to screening are not excluded). 12. History of malignancy, unless the patient is considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years before the first dose. Patients with the following cancers may be included at any time: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or prostate cancer (TNM stage T1a or T1b). 13. Patients who have previously participated in an obinutuzumab beta trial and have received at least one dose of obinutuzumab beta. 14. Known history of allergy to any component of obinutuzumab beta. 15. Clinical evidence of other significant severe diseases; patients who have recently undergone major surgery or are scheduled for major surgery; or any other condition that, in the investigator's judgment, may confound the trial results or place the patient at undue risk.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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