WithdrawnPhase 2

Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy

Stopped: Unable to acquire funding

0Started 2025-07

Plain-language summary

CIDP is a heterogeneous disease with variable responses to therapy. Recently, a distinctive subgroup of patients with serum autoantibodies to the paranodal proteins contactin and neurofascin have been identified. Although they present with active and serious disease, multiple clinical reports suggest that these patients can be cured with a treatment that depletes B cells and presumably eliminates pathogenic autoantibodies. However, beyond that subgroup of CIDP patients, which CIDP patients might benefit from Rituximab and B cell depletion is unknown. This Phase II study will treat 3 homogenous groups of 16 CIDP patients each with Rituximab in order to determine if there are subgroups that can be taken off current medications and put into long-term remission. The results from this study will be used to design a future larger trial. Biomarkers including paranodal antibodies, serum neurofilament light chains, anti-ganglioside antibodies will be obtained in order to learn about disease pathogenesis and possibly target therapy

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent obtained from subjects indicating that they understand the purpose of and procedures required for the study and are willing to participate
✓. Male or female, aged ≥18 years
✓. Documented diagnosis of typical CIDP according to the European Academy of Neurology/Peripheral Nerve Society criteria 202127
✓. Must be willing to complete the study and return for follow-up visits.
✓. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
✓. Successfully treated CIDP patients. Data at or prior to the screening visit must show evidence that during the course of therapy either the INCAT score improved by 1 or more points or improvement occurred according to the physician opinion.
✓. CIDP disease stability is based on 2 visits that are 3 or more months apart documented at or prior to the screening visit by assessing unchanged CIDP status per physician opinion. The subject must be at the same dosage and frequency of CIDP therapy in between these 2 timepoints.
✓. Belonging to 1 of the following 2 treatment groups:

Exclusion criteria

What they're measuring

Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

Timeframe: 48 Weeks

Trial details

NCT IDNCT04480450

SponsorUniversity of Kansas Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09

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