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 94 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
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
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
This study's planned enrollment of 160 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →argenx is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 16 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Sep 2025 (actual). Primary completion is estimated for Oct 2027, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Empasiprubart
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →