A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP (emvigorate)

May 7, 2026 updated by: argenx

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

218

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Rosario, Argentina, S2000DTP
        • Recruiting
        • INECO Neurociencias Oroño
        • Contact:
  • Austria
      • Vienna, Austria, 1090
  • Czechia
      • Brno, Czechia
        • Recruiting
        • Fakultni nemocnice Brno
        • Contact:
  • Estonia
      • Tallinn, Estonia, 11315
      • Tartu, Estonia, 50406
        • Recruiting
        • Tartu University Hospital
        • Contact:
  • France
      • Bordeaux, France, 33076
      • Le Kremlin-Bicêtre, France, 94270
      • Nice, France, 6001
        • Recruiting
        • CHU de Nice-Hôpital Pasteur
        • Contact:
      • Strasbourg, France, 67200
      • Toulouse, France, 31059
        • Recruiting
        • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
        • Contact:
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
      • Kiel, Germany, 24105
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein - Campus Kiel
        • Contact:
  • Greece
      • Athens, Greece, 15562
        • Recruiting
        • University General Hospital of Alexandroupolis
        • Contact:
      • Chaïdári, Greece, 124 62
        • Recruiting
        • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
        • Contact:
  • Israel
      • Ashkelon, Israel, 78278
        • Recruiting
        • The Barzilai University Medical Center
        • Contact:
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center- Ein Kerem
        • Contact:
      • Tel Litwinsky, Israel, 52621
  • Italy
      • Bologna, Italy, 40139
        • Recruiting
        • AUSL di Bologna - Ospedale Bellaria
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
        • Contact:
      • Roma, Italy, 161
        • Recruiting
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I
        • Contact:
      • Roma, Italy, 00189
  • Japan
      • Aomori, Japan, 030-8553
      • Bunkyō City, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Contact:
      • Chūōku, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital
        • Contact:
      • Izunokuni, Japan, 410-2295
        • Recruiting
        • Juntendo Shizuoka University Hospital
        • Contact:
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital
        • Contact:
      • Saga, Japan, 849-8501
        • Recruiting
        • Saga University Hospital
        • Contact:
      • Tsuchiura, Japan, 300-0028
        • Recruiting
        • General Hospital Tsuchiura Kyodo Hospital
        • Contact:
      • Ube, Japan, 755-0067
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht
        • Contact:
  • Norway
      • Oslo, Norway, 450
        • Recruiting
        • Oslo Universitetssykehus HF, Ullevål
        • Contact:
  • Poland
      • Bydgoszcz, Poland, 85-065
        • Recruiting
        • MICS Centrum Medyczne Bydgoszcz
        • Contact:
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Neurocentrum Bydgoszcz
        • Contact:
      • Katowice, Poland, 40-689
      • Krakow, Poland, 30-721
        • Recruiting
        • Centrum Medyczne Linden
        • Contact:
      • Krakow, Poland, 30-688
        • Recruiting
        • SP ZOZ Szpital Uniwersytecki w Krakowie
        • Contact:
      • Lublin, Poland, 20-064
        • Recruiting
        • Galen Clinic - Lublin
        • Contact:
      • Poznan, Poland, 61-731
        • Recruiting
        • Clinical Research Center Sp. z o.o. Medic-R sp.k.
        • Contact:
      • Rzeszów, Poland, 35-210
        • Recruiting
        • Centrum Medyczne Medyk
        • Contact:
      • Szczecin, Poland, 71-252
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Nr 1
        • Contact:
      • Szczecin, Poland, 71-252
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie
        • Contact:
      • Warsaw, Poland, 02-097
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
        • Contact:
  • Portugal
      • Porto, Portugal, 4050-342
        • Recruiting
        • ULS de Santo António, EPE - Hospital de Santo António
        • Contact:
  • Romania
      • Bucharest, Romania, 41914
        • Recruiting
        • Institutul National de Neurologie si Boli Neurovasculare Bucuresti
        • Contact:
      • Constanța, Romania, 900348
        • Recruiting
        • Brainaxy Clinic SRL
        • Contact:
      • Târgu Mureş, Romania, 540136
        • Recruiting
        • Targu-Mures Emergency Clinical County Hospital
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia - Dr Subotica 6
        • Contact:
      • Niš, Serbia, 18 000
        • Recruiting
        • University Clinical Center Nis
        • Contact:
  • Singapore
      • Singapore, Singapore, 308433
  • Slovakia
      • Martin, Slovakia, 036 59
        • Recruiting
        • Univerzitna nemocnica Martin
        • Contact:
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • University Medical Centre Ljubljana
        • Contact:
      • Maribor, Slovenia, 2000
        • Recruiting
        • University Clinical Centre Maribor
        • Contact:
  • South Korea
      • Busan, South Korea, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Contact:
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 05030
        • Recruiting
        • Konkuk University Medical Center
        • Contact:
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System
        • Contact:
  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
      • Sant Andreu de la Barca, Spain, 08740
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
  • Sweden
      • Gothenburg, Sweden, 41346
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
  • Switzerland
      • Geneva, Switzerland, 1205
        • Recruiting
        • Hopitaux Universitaires de Geneve (HUG)
        • Contact:
  • Turkey (Türkiye)
      • Samsun, Turkey (Türkiye), 55200
        • Recruiting
        • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
        • Contact:
  • United States
    • California
      • Rancho Mirage, California, United States, 922701
        • Recruiting
        • Samir Macwan, M.D., Inc.
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Colorado Springs Neurological Associates
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Florida
      • Homestead, Florida, United States, 33033
      • Miami, Florida, United States, 33133
        • Recruiting
        • Visionary Investigators Network
        • Contact:
      • Tampa, Florida, United States, 33616
        • Recruiting
        • University Of South Florida
        • Contact:
    • Louisiana
      • Slidell, Louisiana, United States, 70458
        • Recruiting
        • Paradigm Health System
        • Contact:
    • Maryland
      • Columbia, Maryland, United States, 21044
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital
        • Contact:
    • Texas
      • Houston, Texas, United States, 77094
      • Irving, Texas, United States, 75063
        • Recruiting
        • National Neuromuscular Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
  • Has responded to IVIg in the past 5 years
  • Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
  • Has residual disability and active disease

Exclusion Criteria:

  • Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes
  • Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Use of other long-acting immunomodulatory treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A - empasiprubart + IVIg-placebo
During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.
Other: IVIg-placebo
A placebo resembling the IVIg treatment
Biological: empasiprubart
Intravenous infusion of empasiprubart
Active Comparator: Part A - IVIg + empasiprubart-placebo
During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.
Biological: IVIg
Intravenous infusion of IVIg
Other: empasiprubart-placebo
A placebo resembling the empasiprubart treatment
Experimental: Part B - empasiprubart
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
Intravenous infusion of empasiprubart
Other: empasiprubart-placebo
A placebo resembling the empasiprubart treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of ≥1 point compared with baseline in aINCAT score at week 24
Time Frame: up to 24 weeks
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).
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in I-RODS centile points score at week 24
Time Frame: up to 24 weeks
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).
up to 24 weeks
Change from baseline in MRC-SS at week 24
Time Frame: up to 24 weeks
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).
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
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.
up to 24 weeks
Time to reduction of ≥1 point from baseline in aINCAT score
Time Frame: up to 24 weeks
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).
up to 24 weeks
Change from baseline in TUG at week 24
Time Frame: up to 24 weeks
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.
up to 24 weeks
Time to increase of ≥1 point compared with baseline in aINCAT score
Time Frame: Up to 24 weeks
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).
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 + 96 weeks (Part B)
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.
up to 24 weeks + 96 weeks (Part B)
Change from baseline in grip strength (daily average) for both hands
Time Frame: up to 24 weeks + 96 weeks (Part B)
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.
up to 24 weeks + 96 weeks (Part B)
Change from baseline in MRC-SS over time
Time Frame: up to 96 weeks (Part B)
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).
up to 96 weeks (Part B)
Change from baseline in aINCAT over time
Time Frame: up to 24 weeks (Part A) + 96 weeks (Part B)
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).
up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in EQ-5D-5L over time
Time Frame: up to 24 weeks (Part A) + 96 weeks (Part B)
EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).
up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in RT-FSS over time
Time Frame: up to 24 weeks (Part A) + 96 weeks (Part B)
Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression.
up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in SF-12 over time
Time Frame: up to 24 weeks (Part A) + 96 weeks (Part B)
12-Item Short Form Health Survey (SF-12) is a general patient-reported outcome measure.
up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in BPI-SF over time
Time Frame: up to 24 weeks (Part A) + 96 weeks (Part B)
The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference.
up to 24 weeks (Part A) + 96 weeks (Part B)
PGI-S values over time
Time Frame: up to 24 weeks (Part A) + 96 weeks (Part B)
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.
up to 24 weeks (Part A) + 96 weeks (Part B)
PGI-C values over time
Time Frame: up to 24 weeks (Part A) + 96 weeks (Part B)
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.
up to 24 weeks (Part A) + 96 weeks (Part B)
Values for work-related and household chore activities of the HRPQ
Time Frame: up to 24 weeks
The Health-Related Productivity Questionnaire (HRPQ) assesses health-related and work-related productivity, with questions related to 'hours lost because of absenteeism'.
up to 24 weeks
Percentage of scheduled hours lost in total (absenteeism+ presenteeism)
Time Frame: up to 24 weeks
up to 24 weeks
Change from baseline in I-RODS centile points score over time
Time Frame: Up to 96 weeks (Part B)
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).
Up to 96 weeks (Part B)
Change from baseline in TUG over time
Time Frame: Up to 96 weeks (Part B)
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.
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)
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)
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)
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)
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)
up to 24 weeks (Part A) + 96 weeks (Part B)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-117-2401
  • 2024-520097-36-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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