Chronic Polyradiculoneuritis Clinical Trials

⁃ 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)/Peripheral 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.

• Participant must be on a stable maintenance dosage of IVIg.

• 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.

• 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) of ≥2 points at Screening.

• Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention.

• Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant

• Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.

• Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records.