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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520805-10-00 | EU Trial (CTIS) Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - Empasiprubart | Experimental | Participants receive empasiprubart during part A |
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| Part A - Placebo | Placebo Comparator | Participants receive placebo during part A |
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| Part B - Empasiprubart | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empasiprubart IV | Biological | Intravenous infusion of empasiprubart |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 24 weeks (part A) + 96 weeks (Part B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Coppieters, MD | Contact | 857-350-4834 | clinicaltrials@argenx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham - 1720 University Blvd | Active, not recruiting | Birmingham | Alabama | 35233 | United States |
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| Label | URL |
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| Study website | View source |
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| Placebo IV | Other | Intravenous infusion of placebo |
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| 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) |
| Up to 24 weeks |
| Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24 | 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). | 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. | 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). | Up to 24 weeks |
| Change from baseline in grip strength (3-day moving average) of both hands over time | Up to 24 weeks (part A) |
| Change from baseline in grip strength (daily average) for both hands | 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). | 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). | 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). | 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. | 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. | 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. | 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. | Up to 24 weeks (Part A) + 96 weeks (Part B) |
| Incidence of ADA against empasiprubart in serum | Anti-drug antibodies | Up to 24 weeks + 96 weeks (Part B) |
| Incidence of NAb against empasiprubart in serum | Neutralizing antibodies | Up to 24 weeks + 96 weeks (Part B) |
| Incidence of AEs and SAEs | Up to 24 weeks + 96 weeks (Part B) |
| Percentage change from baseline in free C2 and total C2 over time | Up to 24 weeks (part A) + 96 weeks (Part B) |
| Serum concentrations of empasiprubart over time | 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) | 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). | Up to 96 weeks (Part B) |
| Samir Macwan, M.D., Inc. (S corporation) | Recruiting | Rancho Mirage | California | 92270 | United States |
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| Colorado Springs Neurological Associates | Recruiting | Colorado Springs | Colorado | 80907 | United States |
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| Medstar Health Research Institute | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Gables Neurology | Recruiting | Miami | Florida | 33133 | United States |
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| Aqualane Clinical Research | Recruiting | Naples | Florida | 34105 | United States |
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| Paradigm Health System | Recruiting | Slidell | Louisiana | 70458 | United States |
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| Penn Medicine University City | Recruiting | Philadelphia | Pennsylvania | 19104-5545 | United States |
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| National Neuromuscular Research Institute | Recruiting | Austin | Texas | 78756 | United States |
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| NeuroCarePlus | Recruiting | Houston | Texas | 77094 | United States |
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| INECO Neurociencias Oroño | Active, not recruiting | Rosario | Argentina |
| Kepler Universitätsklinikum Linz - Med Campus III | Active, not recruiting | Linz | Upper Austria | 4021 | Austria |
| Universitätsklinikum AKH Wien | Recruiting | Vienna | 1090 | Austria |
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| Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD | Active, not recruiting | Sofia | Sofia | 1113 | Bulgaria |
| University Multiprofile Hospital for Active Treatment | Recruiting | Pleven | 5803 | Bulgaria |
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| Medical Center Medika 2005 - Branch Sofia | Recruiting | Sofia | 1164 | Bulgaria |
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| University Multiprofile Hospital for Active Treatment Aleksandrovska EAD | Recruiting | Sofia | 1431 | Bulgaria |
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| University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD | Recruiting | Sofia | 1606 | Bulgaria |
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| Fujian Medical University Union Hospital - Yushan Campus | Active, not recruiting | Fuzhou | Fujian | 350108 | China |
| Peking University First Hospital - Changqiao Campus | Recruiting | Beijing | 100034 | China |
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| Guangdong Provincial Hospital of Chinese Medicine | Recruiting | Guangzhou | 510120 | China |
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| Nanfang Hospital Southern Medical University | Recruiting | Guangzhou | 510515 | China |
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| Xi'an Gaoxin Hospital | Recruiting | Xi'an | 710075 | China |
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| Fakultni nemocnice Brno | Recruiting | Brno | 625 00 | Czechia |
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| Rigshospitalet | Active, not recruiting | Copenhagen | 2100 | Denmark |
| Astra Kliinik | Recruiting | Tallinn | 11315 | Estonia |
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| CHU de Lille - Hôpital Roger Salengro | Active, not recruiting | Lille | Nord | 59000 | France |
| AP-HP - Hôpital de la Pitié Salpétrière | Active, not recruiting | Paris | Paris | 75013 | France |
| AP-HP - Hôpital Henri Mondor | Active, not recruiting | Créteil | Val-de-Marne | 94000 | France |
| CHU de Bordeaux - Hôpital | Not yet recruiting | Bourdeaux | France |
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| High Technology Hospital MedCenter Ltd | Recruiting | Batumi | 6000 | Georgia |
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| First Medical Clinic LLC | Recruiting | Batumi | Georgia |
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| Petre Sarajishvili Institute of Neurology | Recruiting | Tbilisi | 0112 | Georgia |
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| Aleksandre Aladashvili Clinic | Recruiting | Tbilisi | 102 | Georgia |
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| Curatio JSC | Recruiting | Tbilisi | 114 | Georgia |
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| LTD New Hospitals | Recruiting | Tbilisi | 114 | Georgia |
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| Geo Hospitals | Recruiting | Tbilisi | 144 | Georgia |
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| Jo Ann Medical Center | Recruiting | Tbilisi | 159 | Georgia |
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| University General Hospital of Alexandroupolis | Active, not recruiting | Alexandroupoli | Evros | 68100 | Greece |
| Fondazione Serena Onlus - Centro Clinico NeMO Brescia | Active, not recruiting | Gussago | Brescia | 25064 | Italy |
| Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara | Active, not recruiting | Trieste | Friuli-VeneziaGiulia | 34149 | Italy |
| IRCCS Istituto delle Scienze Neurologiche di Bologna | Recruiting | Bologna | 40139 | Italy |
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| Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS | Recruiting | Pavia | 27100 | Italy |
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| Institute of Science Tokyo Hospital | Active, not recruiting | Bunkyō-Ku | Tokyo | 113-8519 | Japan |
| Seirei Hamamatsu Hospital | Recruiting | Hiroshima | 430-8558 | Japan |
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| Southern TOHOKU Medical Clinic | Recruiting | Kōriyama | 963-8052 | Japan |
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| Saga University Hospital | Recruiting | Saga | 849-0937 | Japan |
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| Institutul de Neurologie si Neurochirurgie | Active, not recruiting | Chisinau | 2028 | Moldova |
| Centrum Medyczne Neurologia Slaska | Recruiting | Katowice | 40-689 | Poland |
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| SP ZOZ Szpital Uniwersytecki w Krakowie | Recruiting | Krakow | 30-688 | Poland |
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| Galen Clinic - Warszawa | Active, not recruiting | Warsaw | Poland |
| S.C. Neurocity S.R.L | Recruiting | Bucharest | Romania |
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| SC Clubul Sanatatii SRL | Recruiting | Campulung Muscel | 115100 | Romania |
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| Spitalul Judetean de Urgenta Deva | Recruiting | Deva | 330084 | Romania |
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| National Neuroscience Institute | Active, not recruiting | Singapore | Singapore |
| Univerzitna nemocnica MARTIN | Recruiting | Martin | 036 59 | Slovakia |
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| Nemocnica s poliklinikou S. Kukuru a.s. - Pentahospitals | Recruiting | Michalovce | 071 01 | Slovakia |
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| Penta Hospitals SK, a.s. - Rimavská Sobota | Recruiting | Rimavská Sobota | 979 01 | Slovakia |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
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| The National Hospital for Neurology and Neurosurgery - PPDS | Active, not recruiting | London | WC1N3BG | United Kingdom |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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