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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516473-72-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months.
More information can be found here: https://clinicaltrials.argenx.com/empassion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - empasiprubart + IVIg-placebo | Experimental | During the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm |
|
| Part A - IVIg + empasiprubart-placebo | Active Comparator | During the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm |
|
| Part B - empasiprubart | Experimental | After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empasiprubart | Biological | Intravenous infusion of empasiprubart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in grip strength (4-week average) in the most affected hand at week 24 | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MMN-RODS centile score at week 24 | The 25-Item Rasch-Built Overall Disability Scale for MMN (MMN-RODS) is a questionnaire about the relationship between daily activities and the participants' health | Up to 24 weeks |
| Change from baseline in mMRC-14 sum score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology | Scottsdale | Arizona | 85251 | United States | ||
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| Label | URL |
|---|---|
| Study website | View source |
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| IVIG (Intravenous Immunoglobulin) | Biological | Intravenous infusion of IVIg |
|
| Empasiprubart-placebo | Other | A placebo resembling the empasiprubart treatment |
|
| IVIg-placebo | Other | A placebo resembling the IVIg treatment |
|
The modified Medical Research Council (mMRC)-14 is a questionnaire where each muscle group is scored from 0 (paralysis) to 5 (normal strength). A higher value indicates better muscle strength. The total score is based on the sum of both the left and right side of the body. |
| Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| PGI-C actual value | The Patient Global Impression of Change (PGI-C) is a 7-point scale depicting a participant's rating of overall improvement. The lower the score, the better the improvement. | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Change from baseline in CAP-PRI total score | The Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) includes the assessment of 15 items. Items will be scored 0 (not at all), 1 (a little bit), or 2 (a lot), yielding a total score that ranges from 0 to 30. | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Percentage change from baseline in time to complete the 9-HPT with the dominant hand | The 9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and nondominant hands will be tested twice (2 consecutive trials of the dominant hand, followed immediately by 2 consecutive trials of the nondominant hand). | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Incidence of AEs, AESIs and SAEs | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Serum concentrations over time of empasiprubart | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Percent changes from baseline in free C2 and total C2 over time | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Incidence of anti-drug antibodies (ADA) against empasiprubart in serum | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Incidence of NAb against empasiprubart in serum | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Change from baseline in grip strength (3-day moving average) of the least affected hand over time | Up to 24 weeks |
| AUC of change from baseline in grip strength (3-day moving average) for the most and least affected hands | Up to 24 weeks |
| Percentage change from baseline in time to complete the 9-HPT with the nondominant hand over time | The 9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and nondominant hands will be tested twice (2 consecutive trials of the dominant hand, followed immediately by 2 consecutive trials of the nondominant hand). | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Change from baseline in sum scores for mMRC-10 and mMRC-14 restricted to the 2 most affected muscle groups over time | The modified Medical Research Council (mMRC) is a questionnaire where each muscle group is scored from 0 (paralysis) to 5 (normal strength). A higher value indicates better muscle strength. The total score is based on the sum of both the left and right side of the body. | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Proportion of participants and shift from baseline over time by level of severity on PGI-S | Patient Global Impression of Severity (PGIS) is a 7-point scale depicting a participant's rating of overall illness severity. Higher scores mean a higher severity. | Up to 24 weeks |
| Change from baseline in Rasch-Transformed Fatigue Severity Scale (RT-FSS) score over time | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Change from baseline in physical component and mental component scores of 12-Item Short Form Survey (SF-12) over time | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Proportion of participants and shift from baseline by each dimension of the EQ-5D-5L scale | Up to 24 weeks (Part A), Up to 120 weeks (Part B) |
| Changes from baseline in MMN-RODS centile score | The 25-Item Rasch-Built Overall Disability Scale for MMN (MMN-RODS) is a questionnaire about the relationship between daily activities and the participants' health | Up to 120 weeks (part B) |
| Changes from baseline in grip strength (3-day moving average; both hands) | Up to 120 weeks (part B) |
| Actual values of PGI-S over time | Patient Global Impression of Severity (PGIS) is a 7-point scale depicting a participant's rating of overall illness severity. Higher scores mean a higher severity. | Up to 120 weeks (part B) |
| Change from baseline in grip strength (3-day moving average) in the most affected hand at week 24 | Up to 24 weeks |
| The Neurology Group |
| Pomona |
| California |
| 91767 |
| United States |
| Samir Macwan, M.D., Inc. | Rancho Mirage | California | 92270 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic) | Aurora | Colorado | 80045 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | United States |
| Medstar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| EZR Research LLC | Boca Raton | Florida | 33486 | United States |
| Healthcare Innovations Institute, LLC | Coral Springs | Florida | 33067 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Indiana University Health Neuroscience Center | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center | Fairway | Kansas | 66205 | United States |
| Perelman Center for Advanced Medicine | Columbia | Maryland | 21044 | United States |
| UC Irvine - MDA ALS and Neuromuscular Center | Columbia | Maryland | 21044 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| Dent Neurologic Institute Amherst | Amherst | New York | 14226 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of North Carolina at Chapel Hill | Morrisville | North Carolina | 27560 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| National Neuromuscular Research Institute | Austin | Texas | 78759-8402 | United States |
| NeuroCarePlus | Houston | Texas | 77094 | United States |
| Royal Melbourne Hospital | Parkville | 3050 | Australia |
| Gold Coast University Hospital | Southport | 4215 | Australia |
| Brain and Mind Center | Sydney | 2609 | Australia |
| Princess Alexandra Hospital | Woolloongabba | 4102 | Australia |
| Universitätsklinikum AKH Wien | Vienna | 1090 | Austria |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Hôpital de la Citadelle | Liège | 4000 | Belgium |
| Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto | 14051 | Brazil |
| Sociedade de Ensino Superior Estacio de Sa Ltda | Rio de Janeiro | 22620-172 | Brazil |
| Escola Bahiana de Medicina e Saude Publica | Salvador | 40290-000 | Brazil |
| PSEG Centro de Pesquisa Clínica | São Paulo | 04038-002 | Brazil |
| Neuro-Outaouais Clinic | Gatineau | J8Y 1W2 | Canada |
| London Health Sciences Centre | London | N6A 5A5 | Canada |
| St. Paul's Neurology Associates | Vancouver | V6Z 2H2 | Canada |
| Huashan Hospital Fudan University | Shanghai | 200040 | China |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Vseobecna Fakultni Nemocnice V Praze | Prague | 128 08 | Czechia |
| Aarhus Universitetshospital | Aarhus | 8200 | Denmark |
| Rigshospitalet-Inge Lehmanns Vej 8 | Copenhagen | 2100 | Denmark |
| CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | 33000 | France |
| CHU de Brest - Hôpital La Cavale Blanche | Brest | 29609 | France |
| Hospices Civils de Lyon - Hôpital Pierre Wertheimer | Bron | 69500 | France |
| AP-HP - Hôpital Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| Hôpital Roger Salengro | Lille | 59000 | France |
| CHU Limoges - Dupuytren 1 | Limoges | 87042 | France |
| AP-HM- Hôpital de La Timone | Marseille | 13005 | France |
| AP-HM- Hôpital de La Timone | Marseille | 13385 | France |
| CHU de Nice-Hôpital Pasteur | Nice | 6001 | France |
| AP-HP - Hôpital de la Pitié Salpétrière | Paris | 75013 | France |
| CHU de Strasbourg - Hôpital de Hautepierre | Strasbourg | 67200 | France |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Universität Georg August | Göttingen | 37075 | Germany |
| Universitätsklinikum Schleswig-Holstein - Campus Lübeck | Lübeck | 23538 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Alexianer - MVZ St. Josefs-Krankenhaus Potsdam GmbH | Potsdam | 14471 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA | Chaïdári | 124 62 | Greece |
| AHEPA University General Hospital of Thessaloniki | Thessaloniki | 546 36 | Greece |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Ospedale Policlinico San Martino IRCCS | Genova | 16132 | Italy |
| Fondazione Serena Onlus - Centro Clinico NeMO Brescia | Gussago | 25064 | Italy |
| Az. Ospedaliera Universitaria Policlinico G. Martino | Messina | 98124 | Italy |
| Ospedale San Raffaele S.r.l. | Milan | 20132 | Italy |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Milan | 20133 | Italy |
| Azienda Ospedaliero-Universitaria Sant'Andrea | Roma | 00189 | Italy |
| Fondazione PTV Policlinico Tor Vergata | Roma | 133 | Italy |
| IRCCS Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Juntendo University Hospital | Bunkyō City | 113-8431 | Japan |
| Institute of Science Tokyo Hospital | Bunkyō City | 113-8519 | Japan |
| Chiba University Hospital | Chūōku | 260-8677 | Japan |
| National Center of Neurology and Psychiatry | Kodaira | 187-8502 | Japan |
| Nagoya University Hospital | Nagoya | 4668560 | Japan |
| Teikyo University Hospital | tabashi City | 173-8606 | Japan |
| Yamaguchi University Hospital | Ube | 755-0067 | Japan |
| Pauls Stradins Clinical University Hospital | Riga | LV-1002 | Latvia |
| Hospital of Lithuanian University of Health Sciences Kauno klinikos | Kaunas | 50161 | Lithuania |
| Amsterdam UMC | Amsterdam | 1105 AZ | Netherlands |
| Oslo Universitetssykehus HF, Ullevål | Oslo | 0450 | Norway |
| MICS Centrum Medyczne Bydgoszcz | Bydgoszcz | 85-065 | Poland |
| Centrum Medyczne Neurologia Slaska | Katowice | 40-689 | Poland |
| SP ZOZ Szpital Uniwersytecki w Krakowie | Krakow | 30-688 | Poland |
| Galen Clinic -- Lublin | Lublin | 20--64 | Poland |
| UCK WUM, Centralny Szpital Kliniczny | Warsaw | 02-097 | Poland |
| ULS de Santo António, EPE - Hospital de Santo António | Porto | 4099-001 | Portugal |
| University Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Univerzitna nemocnica Bratislava | Bratislava | 821 01 | Slovakia |
| Univerzitna nemocnica MARTIN | Martin | 036 59 | Slovakia |
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| Hospital General Universitario Dr. Balmis | Alicante | 03010 | Spain |
| Hospital Universitario Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de La Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Clinico San Carlos | Madrid | 28039 | Spain |
| Hospital Universitario de Basurto | Madrid | 48013 | Spain |
| Hospital Quironsalud Malaga | Málaga | 29004 | Spain |
| Hospital Universitario de Donostia | San Sebastián | 8035 | Spain |
| Inselspital - Universitätsspital Bern | Bern | 3010 | Switzerland |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 7LE | United Kingdom |
| Salford Royal Hospital | Salford | M6 8HD | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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