A Phase 3 interventional study of Empasiprubart IV and Placebo IV in Chronic Inflammatory Demyelinating Polyneuropathy, CIDP and Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by argenx. Recruiting at 85 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by argenx · Phase 3, Interventional, and Treatment
The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).
More information can be found here: https://clinicaltrials.argenx.com/emnergize
Exclusion Criteria:
Participants receive empasiprubart during part A
Biological: Empasiprubart IV
Participants receive placebo during part A
Other: Placebo IV
Participants receive empasiprubart during part B. Participants from the empasiprubart arm in part A will receive placebo once to maintain the blind of part A.
Biological: Empasiprubart IV
Intravenous infusion of empasiprubart
Intravenous infusion of placebo
Reduction of ≥1 point compared with baseline in aINCAT score at 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 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)
Plan to share: No
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating→
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