Phase 3 study evaluating efficacy and safety of riliprubart versus IVIg in CIDP - VITALIZE
Study Description
Eligibility
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/ Peripherial Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).
- Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.
- Participants must have responded to IVIg in the past 5 years. Response must be an objective clinically meaningful improvement defined by at least one of the following: greater or equal to 1 point decrease in adjusted INCAT score, greater or equal to 4 points increase in I-RODS total score, greater or equal to 3 points increase in the MRC-SS, greater or equal to 8 kilopascal improvement in mean grip strength (1 hand), or an equivalent improvement based on information documented in medical records as per the Investigator's judgment.
- Participant must be on a stable maintenance dosage of IVIg, defined as no change greater than 10% in frequency or dose of IVIg within 8 weeks prior to Screening, and remaining stable until baseline.
- Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT).
- Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN/PNS 2021 CIDP guidelines: 0.4 to 1 g/kg every 2 to 6 weeks.
- Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline.
- Participant must have active disease, defined by a CIDP disease activity score (CDAS) XE " CDAS " \f Abbreviation \t "CIDP disease activity score" of greater or equal to 2 points at Screening.
- Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years of Screening or initiated a minimum of 14 days prior to first dose of study intervention.
- All participants must agree to use contraception methods during and after the study as required.
- Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- A male participant is eligible to participate if they agree to the following during the study intervention period and for at least 55 weeks after the last dose of study medication.
- Refrain from donating or cryopreserving sperm.
PLUS, either:
--Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
OR
Must agree to use contraception/barrier as detailed below:
- A male condom and an additional highly effective contraceptive method (Contraceptive and barrier guidance per protocol) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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