Comparing KITE-363 with Fludarabine for chronic inflammatory demyelinating polyneuropathy

Inclusion

• +Expanded Disability Status Scale (EDSS) 0 to 5.5
• +EDSS of 3 to 6.5 who are ambulatory
• +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for multiple sclerosis (MS):
• +MS (Relapsing and progressive forms):
• +Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria
• +Relapsing forms of MS (relapsing-remitting multiple sclerosis (RRMS), active secondary-progressive multiple sclerosis (aSPMS)):
• +Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more → while on high efficacy disease-modifying therapy (DMT) OR Inadequate response to previous therapies defined as intolerance to ≥ 2 DMTs due to side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more → prohibiting the chronic use of the DMT.
• +Progressive forms of MS (primary-progressive multiple sclerosis (PPMS) and non-active secondary-progressive multiple sclerosis (naSPMS)):
• +Inadequate response to previous therapies is defined as evidence of disease progression within 12 months prior to screening despite standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → therapy for naSPMS or despite ocrelizumab, where available, for PPMS
• +Absence of clinical relapses for at least 24 months
• +No evidence of Gadolinium enhancing (GadE+) on magnetic resonance imaging (MRI) brain at screening or baselineBaselineYour starting measurements, taken before treatment begins.Read more →
• +Inclusion Criteria for myasthenia gravis (MG):
• +Documentation of autoantibodies against acetylcholine receptor (AChR), muscle-specific kinase (MuSK), or low-density lipoprotein receptor-related protein 4 (LRP4)
• +Diagnosis of MG with generalized weakness meeting criteria as defined by the Myasthenia Gravis Foundation of American (MGFA) classification of II- IV at screening
• +Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6 (\> 50% of the total score due to non-ocular symptoms)
• +Quantitative Myasthenia Gravis (QMG) score ≥ 10
• +Inadequate response to previous therapies while taking at least 2 classes of immunosuppressants (ie, steroids, azathioprine (AZA), mycophenolate mofetil (MMF), intravenous immunoglobulin (IVIg), biologics (eg, rituximab, anti-neonatal fragment crystallizable (Fc) receptor (FcRN) class, and anti-complement class))
• +Thymectomy allowed if completed ≥ 12 months prior to screening
• +Inclusion Criteria for chronic inflammatory demyelinating polyneuropathy (CIDP):
• +Probable or definite CIDP as defined by the 2010 European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria, relapsing or progressive forms
• +CIDP Disease Activity Status (CDAS) score ≥ 3 at screening
• +Inflammatory neuropathy cause and treatment (INCAT) score ≥ 3
• +Inadequate response to previous therapies despite standard of care therapy (ie, steroids, IVIg, subcutaneous immunoglobulin (SCIg), plasmapheresis exchange (PLEX), rituximab, or anti FcRN) OR Unable to tolerate standard of care due to side effects with ongoing disease activity
• +Except for nodal/paranodal CIDP, historical documentation of objective improvement in the past 24 months while on IVIg, SCIg, PLEX, or anti-FcRN OR Historical documentation of objective disease worsening in the past 24 months when IVIg, SCIg, PLEX, or anti-FcRN has been reduced or interrupted
• +Reproductive status-related eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → and contraception requirements:
• +Participants must agree to use protocolProtocolThe detailed plan a study must follow.Read more →-specified method(s) of contraception where applicable