A Phase 3 interventional study of empasiprubart and IVIg in Chronic Inflammatory Demyelinating Polyneuropathy, CIDP and CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by argenx. Recruiting at 107 sites in 31 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by argenx · Phase 3, Interventional, and Treatment
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart 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/emvigorate
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
This study's planned enrollment of 218 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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.
Biological: empasiprubart · Other: IVIg-placebo
During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.
Biological: IVIg · Other: empasiprubart-placebo
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.
Biological: empasiprubart · Other: empasiprubart-placebo
Intravenous infusion of empasiprubart
Intravenous infusion of IVIg
A placebo resembling the empasiprubart treatment
A placebo resembling the IVIg treatment
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 at week 24
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
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
The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days.
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 at week 24
The Timed Up and Go Test (TUG) is a simple test to 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
Time to increase of ≥1 point compared with 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 grip strength (3-day moving average) of both hands over time
The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days.
Time frame: up to 24 weeks + 96 weeks (Part B)
Change from baseline in grip strength (daily average) for both hands
The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. A daily average will be generated based on the average of the obtained averages for each hand.
Time frame: up to 24 weeks + 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 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 (Part A) + 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 SF-12 over time
12-Item Short Form Health Survey (SF-12) is a general patient-reported outcome measure.
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 patient-reported 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)
Values for work-related and household chore activities of the HRPQ
The Health-Related Productivity Questionnaire (HRPQ) assesses health-related and work-related productivity, with questions related to 'hours lost because of absenteeism'.
Time frame: up to 24 weeks
Percentage of scheduled hours lost in total (absenteeism+ presenteeism)
Time frame: up to 24 weeks
Change from baseline in I-RODS centile points score over time
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 96 weeks (Part B)
Change from baseline in TUG over time
The Timed Up and Go Test (TUG) is a simple test to 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 96 weeks (Part B)
Incidence of antidrug antibodies against empasiprubart in serum
Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)
Incidence of neutralizing antibodies against empasiprubart in serum
Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)
Incidence of (serious) adverse events
Time frame: up to 24 weeks (Part A) + 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)
Showing the first 100 of 107 sites across 31 countries. Choose a country and city above to see the rest.
Plan to share: No
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 ↗
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Studies of the drug tested here: Empasiprubart
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →