Chronic Inflammatory Demyelinating PolyneuropathyPhase 3emnergizeNCT07091630
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
A Phase 3 study testing Empasiprubart IV in people with Chronic Inflammatory Demyelinating Polyneuropathy and CIDP, run by argenx at 89 sites in 25 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- What is being tested?
- Empasiprubart IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 89 sitesin 25 countries
- Study dates
- 16 Sep 2025to 23 Jan 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
- Has residual disability and active disease
- Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
- Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP
Who cannot join
- Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
- Sensory CIDP (including sensory-predominant CIDP)
- Polyneuropathy of other causes
- Clinical diagnosis of systemic lupus erythematosus (SLE)
- Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation
Trial locations and contacts
89 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
89 sites in 25 countries
United States13 sites, 13 recruiting
- Recruiting
National Neuromuscular Research Institute
Austin, Texas, 78756
Yessar Hussain, MD, 512-920-0140, yessar@austinneuromuscle.com
- Recruiting
University of Alabama at Birmingham - 1720 University Blvd
Birmingham, Alabama, 35233
Eroboghene Ubogu, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
David Stevens, MD, 719-389-1159, dstevens@csneuro.com
- Recruiting
NeuroCarePlus
Houston, Texas, 77094
Nicolas Nammour, MD, 281-579-6800, nicolas.nammour@sclamanagement.com
- Recruiting
University Neurology
Knoxville, Tennessee, 37920-1511
Christopher Scheiner, MD, 865-521-6174, cscheiner@utmck.edu
- Recruiting
Gables Neurology
Miami, Florida, 33133
Andrew Lerman, MD, 954-243-5559, alerman@fcneurology.net
- Recruiting
Aqualane Clinical Research
Naples, Florida, 34105
Matthew Baker, MD, 650-723-6961, Matthew@aqualaneresearch.com
- Recruiting
Penn Medicine University City
Philadelphia, Pennsylvania, 19104-5545
Sami Khella, MD, 215-662-8870, sami.khella@pennmedicine.upenn.edu
- Recruiting
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
Goran Rakocevic, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, California, 92270
Samir Macwan, MD, 760-834-3540, smacwan@southlandneuromuscular.com; samirmacwan@gmail.com
- Recruiting
Paradigm Health System
Slidell, Louisiana, 70458
Patrick Glynn, MD, 985-882-4500, trickpatglynn@yahoo.com
- Recruiting
Vero Beach Neurology and Research Institute
Vero Beach, Florida, 32960-4806
Stuart Shafer, (888) 888-8888, sshafer@geodysseyrsch.com
- Recruiting
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010
Yasir Al-Khalili, MD, 857-350-4834, yasir.al-khalili@medstar.net
Georgia8 sites, 8 recruiting
- Recruiting
High Technology Hospital MedCenter Ltd
Batumi, 6000
Shorena Vashadze, MD, +995 577 413 466, dake58@mail.ru
- Recruiting
First Medical Clinic LLC
Batumi
Gucha Kobaidze, MD, +995 595 252 925, kobaidze.guchi@gmail.com
- Recruiting
Petre Sarajishvili Institute of Neurology
Tbilisi, 0112
Roman Shakarishvili, MD, +995599167442, info.sarion@gmail.com
- Recruiting
Aleksandre Aladashvili Clinic
Tbilisi, 102
Mariam Kheladze, MD, +995 595 040 101, marikheladze@yahoo.com
- Recruiting
Curatio JSC
Tbilisi, 114
Tengiz Tsuladze, MD, +995 599 156 391, ttsuladze@curatio.ge
- Recruiting
LTD New Hospitals
Tbilisi, 114
Temur Margania, MD, +995577753204, temargania@yahoo.com
- Recruiting
Geo Hospitals
Tbilisi, 144
Kakhaber Akhvlediani, MD, +995 599 542 236, kaxabra@gmail.com
- Recruiting
Jo Ann Medical Center
Tbilisi, 159
Miranda Demuria, MD, +995 598 359 525, mirandademuria@gmail.com
Brazil7 sites, 7 recruiting
- Recruiting
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
Brasília, 70200-730
Hamilton Cirne, MD, +55 61-99161-4490, hamiltoncirne@gmail.com
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, 90560-032
Marcelo Vianna Raffo, MD, +55 (51) 3314-3209, marceloraffo82@gmail.com
- Recruiting
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Pôrto Alegre, Rio Grande do Sul, 90560-030
Pablo Brea Winckler, 5551992614676, pwinckler@hcpa.edu.br
- Recruiting
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - UPS - PPDS
Ribeirão Preto, São Paulo, 14051-140
Wilson Marques, 551636022391, wmjunior@fmrp.usp.br
- Recruiting
Unidade de Pesquisa Clinica e Inovacao da Estacio
Rio de Janeiro, Rio de Janeiro, 22640-100
Osvaldo Nascimento, 5521999846044, osvaldo_nascimento@hotmail.com
- Recruiting
Escola Bahiana de Medicina e Saude Publica
Salvador, Estado de Bahia, 40290-000
Marcela Costa, +55 71 32768232 / +55 71 9889, marcelamachado@bahiana.edu.br
- Recruiting
PSEG Centro de Pesquisa Clinica
São Paulo, 04038-002
Paulo Sgobbi de Souza, MD, +551150845436, pvsgobbi@gmail.com
Italy7 sites, 7 recruiting
- Recruiting
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, 40139
Vincenzo Donadio, MD, +390514966113, vincenzo.donadio@unibo.it
- Recruiting
IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
Genova, 16132
Chiara Gemelli, MD, +1 857-350-4834, chiara.gemelli@aomliguria.it
- Recruiting
Fondazione Serena Onlus - Centro Clinico NeMO Brescia
Gussago, Brescia, 25064
Massimiliano Filosto, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Ospedale San Raffaele S.r.l.
Milan, 20132
Stefano Previtali, MD, +390226433036, previtali.stefano@hsr.it
- Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, 27100
Elisa Vegezzi, MD, +393487648786, elisa.vegezzi@mondino.it
- Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
Trieste, Friuli-VeneziaGiulia, 34149
Paolo Manganotti, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
Trieste, 34149
Alberto Benussi, MD, +390303995632, alberto.benussi@units.it
China6 sites, 6 recruiting
- Recruiting
Peking University First Hospital - Changqiao Campus
Beijing, 100034
Lingchao Meng, MD, +8613811624903, xcc198616@163.com
- Recruiting
Fujian Medical University Union Hospital - Yushan Campus
Fuzhou, Fujian, 350108
Zhangyu Zou, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
The People's Hospital of Baiyun District Guangzhou
Guangzhou, Guangdong, 510440
Haishan Jiang, MD, 18665604153, 156760888@qq.com
- Recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, 510120
Yuanqi Zhao, MD, +8613725137130, tcm2008@126.com
- Recruiting
Nanfang Hospital Southern Medical University
Guangzhou, 510515
Haishan Jiang, MD, +862061641888, 156760888@qq.com
- Recruiting
Xi'an Gaoxin Hospital
Xi'an, 710075
Zunbo Li, MD, +862988330116, lzb88031347@126.com
Bulgaria5 sites, 5 recruiting
- Recruiting
University Multiprofile Hospital for Active Treatment
Pleven, 5803
Maya Danovska-Mladenova, MD, +359887381827, mdanovska@yahoo.com
- Recruiting
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
Sofia, Sofia, 1113
Ivan Milanov, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Medical Center Medika 2005 - Branch Sofia
Sofia, 1164
Plamen Tsvetanov, MD, +359888677914, tsvetanovmd@mail.bg
- Recruiting
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, 1431
Ivaylo Tarnev, MD, +359899844317, itournev@emhpf.org
- Recruiting
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, 1606
Mariya Dimitrova, MD, +359886850961, dr.m.i.dimitrova@gmail.com
France5 sites, 5 recruiting
- Recruiting
CHU de Bordeaux - Hôpital
Bourdeaux
Gwendal Le Masson, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
AP-HP - Hôpital Henri Mondor
Créteil, Val-de-Marne, 94000
Thierry Gendre, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
CHU de Lille - Hôpital Roger Salengro
Lille, Nord, 59000
Celine Tard, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
CHU de Nice-Hôpital Pasteur
Nice, 6001
Sabrina Sacconi, MD, +33492035757, sacconi.s@chu-nice.fr
- Recruiting
AP-HP - Hôpital de la Pitié Salpétrière
Paris, Paris, 75013
Charline Benoit, MD, +1 857-350-4834, clinicaltrials@argenx.com
Japan4 sites, 4 recruiting
- Recruiting
Institute of Science Tokyo Hospital
Bunkyō-Ku, Tokyo, 113-8519
Sonoko Misawa, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Seirei Hamamatsu Hospital
Hiroshima, 430-8558
Keishiro Sato, MD, +81534741264, k-sato@sis.seirei.or.jp
- Recruiting
Southern TOHOKU Medical Clinic
Kōriyama, 963-8052
Chikako Kaneko, MD, +81249345432, kanekochikako_chiken@yahoo.co.jp
- Recruiting
Saga University Hospital
Saga, 849-0937
Haruki Koike, MD, +81952316511, koike-haruki@med.nagoya-u.ac.jp
Romania4 sites, 4 recruiting
- Recruiting
Regina Maria Brasov Hospital
Brasov, 500091
Letitia Zecheru-Lapusneanu, MD, +400740143118, letitialapusneanu@yahoo.com
- Recruiting
S.C. Neurocity S.R.L
Bucharest
Dan Mitrea, MD, +40723226233, dan.mitrea@neuroaxis.ro
- Recruiting
SC Clubul Sanatatii SRL
Campulung Muscel, 115100
Silviu Manescu, MD, +40722559718, silviumanescu@yahoo.com
- Recruiting
Spitalul Judetean de Urgenta Deva
Deva, 330084
Cecilia Albu, MD, +40740067124, albu.cecilia@yahoo.com
United Kingdom4 sites, 4 recruiting
- Recruiting
Kent and Canterbury Hospital
Canterbury, Kent, CT13NG
Sarah Siddiqui, +1 857-350-4834, ekhuft.researchandinnovation@nhs.net
- Recruiting
The National Hospital for Neurology and Neurosurgery - PPDS
London, WC1N3BG
Junie (Shiwen) Koay, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Queen's Medical Centre
Nottingham, Nottinghamshire, NG72UH
Philip Ambrose, MD, + 44 8888888888, philip.ambrose@nuh.nhs.uk
- Recruiting
Salford Royal Hospital
Salford, M6 8HD
Ryan (Yann Shern) Keh, MD, +44 161 206 2427, ryan.keh2@nca.nhs.uk
Argentina3 sites, 3 recruiting
- Recruiting
Instituto Privado Kremer
Córdoba, X5004AOA
Carlos Deabato, MD, deabatoarg@gmail.com
- Recruiting
Instituto Médico de la Fundación Estudios Clínicos
Rosario, S2000DEJ
Bernardo Tentella, MD, bernardotentella@consultoriosintegrados.org
- Recruiting
INECO Neurociencias Oroño
Rosario
Dario Tavolini, MD, +1 857-350-4834, clinicaltrials@argenx.com
Poland3 sites, 3 recruiting
- Recruiting
Centrum Medyczne Neurologia Slaska
Katowice, 40-689
Marek Smilowski, MD, +48500282494, marek.smilowski@neurologiaslaska.pl
- Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 30-688
Agnieszka Slowik, MD, +48 12 400 25 51, neurologiabk@su.krakow.pl
- Recruiting
Galen Clinic - Warszawa
Warsaw
Urszula Chyrchel-Paszkiewicz, MD, 857-350-4834, clinicaltrials@argenx.com
Slovakia3 sites, 3 recruiting
- Recruiting
Univerzitna nemocnica MARTIN
Martin, 036 59
Monika Turcanova Koprusakova, MD, +421434203660, koprusakova@gmail.com
- Recruiting
Nemocnica s poliklinikou S. Kukuru a.s. - Pentahospitals
Michalovce, 071 01
Martin Suc, MD, +421566416813, martin.suc@pentahospitals.sk
- Recruiting
Penta Hospitals SK, a.s. - Rimavská Sobota
Rimavská Sobota, 979 01
Erika Zacharova, MD, +421905729028, erika.zacharova@pentahospitals.sk
Austria2 sites, 2 recruiting
- Recruiting
Kepler Universitätsklinikum Linz - Med Campus III
Linz, Upper Austria, 4021
Christian Eggers, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum AKH Wien
Vienna, 1090
Jakob Rath, MD, +4314040031170, jakob.rath@meduniwien.ac.at
Greece2 sites, 2 recruiting
- Recruiting
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Aikaterini Terzoudi, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Eginitio Hospital
Athens
Leonidas Stefanis, MD, +302107289448, lstef.clinicaltr@gmail.com
Israel2 sites, 2 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 3820302
Adi Hersalis-Eldar, MD, +972 52 56103121, adie@hymc.gov.il
- Recruiting
The Chaim Sheba Medical Center - PPDS
Ramat Gan, 52621
Amir Dori, MD, 972 52 5837575, amir.dori@sheba.health.gov.il
Moldova2 sites, 2 recruiting
- Recruiting
Institutul de Neurologie si Neurochirurgie
Chisinau, 2028
Vitalie Lisnic, MD, +373-79456641, vitalie.lisnic@usmf.md
- Recruiting
Institutul de Neurologie si Neurochirurgie
Chisinau, 2028
Olesea Odainic, MD, +37379443354, oodainic@mail.ru
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Sung Min Kim, MD, +821054056194, sueh916@gmail.com
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Hye Lim Lee, MD, 888888888, hllee@korea.ac.kr
Colombia1 site, 1 recruiting
- Recruiting
Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico
Medellín, Antioquia, 50012
Lina Maria Agudelo Ramos, 57 604 5766666, lina.agudelo@neurologico.org.co
Czechia1 site, 1 recruiting
- Recruiting
Fakultni nemocnice Brno
Brno, 625 00
Magda Horakova, MD, +420734427851, horakova.magda@fnbrno.cz
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Tina Dysgaard, MD, 857-350-4834, clinicaltrials@argenx.com
Estonia1 site, 1 recruiting
- Recruiting
Astra Kliinik
Tallinn, 11315
Katrin Gross-Paju, MD, +37253323052, katrin.gross-paju@astrakliinik.ee
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete
Budapest, 1082
Maria Judit Molnar, MD, molnarmj@gmail.com
Netherlands1 site, 1 recruiting
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Ludo van der Pol, MD, w.l.vanderpol@umcutrecht.nl
Singapore1 site, 1 recruiting
- Recruiting
National Neuroscience Institute
Singapore
Peng Soon Ng, MD, 857-350-4834, clinicaltrials@argenx.com
About this study
Official title: A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
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
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Being tested
- Empasiprubart IV, Placebo IV
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empasiprubart IVBiological
Intravenous infusion of empasiprubart
Placebo IVOther
Intravenous infusion of placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A - Empasiprubart | Experimental | Participants receive empasiprubart during part A Receives: Biological: Empasiprubart IV |
| Part A - Placebo | Placebo comparator | Participants receive placebo during part A Receives: Other: Placebo IV |
| 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. Receives: Biological: Empasiprubart IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 24 weeks
Secondary outcomes (22)
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).
Measured: 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)
Measured: Up to 24 weeks
Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24
Measured: 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).
Measured: 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.
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).
Measured: Up to 24 weeks
Change from baseline in grip strength (3-day moving average) of both hands over time
Measured: Up to 24 weeks (part A)
Change from baseline in grip strength (daily average) for both hands
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 weeks (Part A) + 96 weeks (Part B)
Incidence of ADA against empasiprubart in serum
Anti-drug antibodies
Measured: Up to 24 weeks + 96 weeks (Part B)
Incidence of NAb against empasiprubart in serum
Neutralizing antibodies
Measured: Up to 24 weeks + 96 weeks (Part B)
Incidence of AEs and SAEs
Measured: Up to 24 weeks + 96 weeks (Part B)
Percentage change from baseline in free C2 and total C2 over time
Measured: Up to 24 weeks (part A) + 96 weeks (Part B)
Serum concentrations of empasiprubart over time
Measured: 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)
Measured: 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).
Measured: Up to 96 weeks (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start16 Sep 2025
- Primary completion7 Oct 2027 (estimated)
- Study completion23 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091630
- Sponsor's protocol ID
- ARGX-117-2402
- Other IDs
- 2025-520805-10-00, 2025
- Acronym
- emnergize
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No