A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP

Change from baseline in I-RODS centile points score

Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).

Time frame: Up to 24 weeks (part A) + 96 weeks (Part B)

Change from baseline in MRC-SS at week 24

The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome)

Time frame: Up to 24 weeks

Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24

Time frame: Up to 24 weeks

Time to reduction of ≥1 point from baseline in aINCAT score

The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

Time frame: Up to 24 weeks

Change from baseline in TUG

The Timed Up and Go Test (TUG) is a simple test top assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.

Time frame: Up to 24 weeks (part A) + 96 weeks (Part B)

Time to increase of ≥1 point compared with baseline in aINCAT score up to week 24

The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

Time frame: Up to 24 weeks

Change from baseline in grip strength (3-day moving average) of both hands over time

Time frame: Up to 24 weeks (part A)

Change from baseline in grip strength (daily average) for both hands

Time frame: Up to 96 weeks (Part B)

Change from baseline in MRC-SS over time

The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).

Time frame: Up to 96 weeks (Part B)

Change from baseline in aINCAT score over time

The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

Time frame: Up to 24 weeks + 96 weeks (Part B)

Change from baseline in EQ-5D-5L over time

EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).

Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

Change from baseline in RT-FSS over time

Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression.

Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

Change from baseline in BPI-SF over time

The Brief Pain Inventory-Short Form (BPI-SF) is a patientreported outcome measure to assess pain severity and pain interference.

Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

PGI-S values over time

The Patient Global Impression of Severity (PGI-S) is a patient-reported outcome measure that reflects the patient's belief about the severity of the illness.

Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

PGI-C values over time

The Patient Global Impression of Change (PGI-C) is a patient-reported outcome measure that reflects the patient's belief about the efficacy of treatment.

Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

Incidence of ADA against empasiprubart in serum

Anti-drug antibodies

Time frame: Up to 24 weeks + 96 weeks (Part B)

Incidence of NAb against empasiprubart in serum

Neutralizing antibodies

Time frame: Up to 24 weeks + 96 weeks (Part B)

Incidence of AEs and SAEs

Time frame: Up to 24 weeks + 96 weeks (Part B)

Percentage change from baseline in free C2 and total C2 over time

Time frame: Up to 24 weeks (part A) + 96 weeks (Part B)

Serum concentrations of empasiprubart over time

Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

Reduction of ≥1 point in aINCAT over time

The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome)

Time frame: Up to 96 weeks (Part B)

Increase of ≥1 point from baseline in aINCAT over time

The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

Time frame: Up to 96 weeks (Part B)