Comparing riliprubart with IVIg for chronic inflammatory demyelinating polyneuropathy

Exclusion

• −Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.
• −Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →).
• −hepatitis B surface antigen (HbsAg).
• −anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \[anti-HBs Ab\] are also positive, indicating natural immunity).
• −anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more →, only if a confirmatory negative Hepatitis RNA test is obtained.
• −Participants are excluded from the study if any of the following criteria apply:
• −Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy.
• −Sensory CIDP, distal CIDP and focal CIDP variants.
• −Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.
• −Poorly controlled diabetes
• −Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections).
• −Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.
• −Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per the Investigator's judgment.
• −Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.
• −Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.
• −Recent treatment with plasma exchange
• −Treatment within 3 months prior to dosing with immunosuppressive/ immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive/ chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine).
• −Prior treatment with riliprubart.
• −Recent use of any specific complement system inhibitor (eg, eculizumab).
• −Prior treatment with B-cell depleting agents such as rituximab within 6 months.
• −Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).
• −Participation in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening.
• −Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial.
• −Positive result of any of the following tests:
• −anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.
• −Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized.
• −Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
• −Participants are employees of the clinical study siteTrial siteA hospital or clinic where a study is actually run.Read more → or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.
• −Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocolProtocolThe detailed plan a study must follow.Read more →.
• −Recent treatment with efgartigimod.
• −The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
• −Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.
• −Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.
• −Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation.