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New hope for rare nerve disease: rituximab trial targets good responders

NCT ID NCT05136976

Disease control Sponsor: Centre Hospitalier Universitaire de Saint Etienne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether the drug rituximab can improve disability in people with anti-MAG neuropathy, a rare nerve condition that causes progressive weakness and numbness. The study will enroll 90 participants who have had the disease for 5 years or less and have shown recent worsening. Participants receive two infusions of rituximab or a placebo, and researchers measure changes in daily function after 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rituximab (Mabthera) infusion
What this could lead to
If it works, this could provide an effective treatment for anti-MAG neuropathy, a rare nerve disease with no proven therapy.
What could go wrong
Two previous trials of rituximab for this condition failed to show benefit. This trial selects patients with specific characteristics that may improve chances, but success is not guaranteed.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Disease duration of 5 years or less and documented clinical worsening (clinical or ENMG or disability) over the past 24 months * IgM gammopathy, either MGUS or Waldenstrom Macroglobulinemia (WM) * Demyelinating polyneuropathy according to European Federation of Neurological Societies/Peripheral Nerve Society guidelines for chronic inflammatory demyelinating polyneuropathy on nerve conduction studies. * Anti-MAG titre of 10 000 BTU or more * Total INCAT score of 1 point or more at baseline * Absence of immunoglobulin treatment within 3 months prior to inclusion. * Absence of immunosuppressive therapy within 6 months prior to inclusion, including steroid therapy of 2 months or more as part of the management of neuropathy. * Negative β-human chorionic gonadotropin (HCG) in women of childbearing potential * Women of childbearing potential must agree to use contraception for 365 days following administration of rituximab. Exclusion Criteria: * \- Unable to give informed consent * History of severe allergic or anaphylactic reaction to chimeric monoclonal antibody * Hypersensitivity known to one of the compounds of polaramine or methylprednisolone * Previous treatment with rituximab * Diseases known to cause polyneuropathy (e.g. diabetes, uncontrolled thyroid disease, vitamin B1 or B12 deficiency, renal (GFR \< 60ml ml/min/1,73 m2- Modification of Diet in Renal Disease (MDRD) formula) or liver disorder, myeloma, amyloidosis, cryoglobulinemia) * Indication of specific immunosuppressive therapy for WM * Significant uncontrolled disease at baseline such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal or any other significant disease that may prevent patient from participating in the study * Congestive heart failure (NYHA III or IV) * Known active bacterial, viral, fungal mycobacterial infection * History or known presence of recurrent or chronic infection (e.g. viral hepatitis, HIV syphilis, tuberculosis). * History of cancer, including solid tumors and haematological malignancies (except basal cell and in situ squamous carcinoma of the skin, in situ carcinoma of the cervix of the uterus that have been excised and resolved, with documented clear margins on pathology) * History of alcohol (more than two drinks a day for a woman, more than 4 glasses a day for a man \[World Health Organization (WHO) definition\]) or other drug abuse within 6 months prior to randomization * History or currently active primary or secondary immunodeficiency * White blood cell count \< 1500/mm3 or platelet count \< 75 000/mm3 * Angle closure glaucoma, * Urinary retention related to urethroprostatic disorders, * Uncontrolled psychotic disorders, * Severe liver failure, * Recent vaccination with live vaccines (\<3months) and vaccination with live virus vaccines is not recommended during the overall study period.

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Conditions

The condition(s) this trial relates to.

polyneuropathy associated with IgM monoclonal gammapathy with anti-MAG

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-mag neuropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • APHP - Kremlin-Bicêtre

    RECRUITING

    Paris, 94270, France

  • APHP Pitié Salpêtrière

    RECRUITING

    Paris, 75651, France

  • CHU Brest - La cavale blanche

    RECRUITING

    Brest, 29200, France

  • CHU Grenoble - La tronche

    RECRUITING

    Grenoble, 38700, France

  • CHU La Timone - APHM

    RECRUITING

    Marseille, 13915, France

  • CHU Lille - Roger Salengro

    RECRUITING

    Lille, 59037, France

  • CHU Limoges - Dupuytren

    RECRUITING

    Limoges, 87170, France

  • CHU Nancy- Hôpital central

    RECRUITING

    Nancy, 54035, France

  • CHU Nice - Pasteur

    RECRUITING

    Nice, 06031, France

  • CHU Strasbourg - Hautepierre

    RECRUITING

    Strasbourg, 67091, France

  • CHU Toulouse - Pierre-Paul Riquet

    RECRUITING

    Toulouse, 31059, France

  • CHU Tours - Bretonneau

    RECRUITING

    Tours, 37044, France

  • CHU de Saint-Etienne

    RECRUITING

    Saint-Etienne, France

  • HCL lyon

    RECRUITING

    Lyon, 69002, France

  • Hôtel-Dieu et Hôpital GR Laënnec - CHU Nantes

    RECRUITING

    Nantes, France

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Other studies related to the condition(s) this trial covers.