NCT04280718Active, not recruitingPhase 2
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Source: ClinicalTrials.gov · Last updated 29 Jun 2025
Brief summary (registry, in English)
This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 229 (actual)
- First submitted
- 20 Feb 2020
- Start date
- 18 Sept 2020
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- argenx
- NCT number
- NCT04280718
- EU CT number
- 2023-507885-21-00
- EudraCT number
- 2019-003107-35
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 229
- From 18 Sept 2020 to the primary completion date, 30 Apr 2027
- 135 sites in 24 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP.
Other illness
- Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.
Other
- Pregnant and lactating women and those intending to become pregnant during the trial.
Who the study is looking for
- Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial.
- Male or female patient with one of the following options:
- Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or
- Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or
- Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
- Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment.
- Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
- Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (135)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johannes Kepler University Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Military Medical Academy Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| Alexandrovska University Hospital Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Investigator site 0860033 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Investigator site 860041 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Investigator site 0860036 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Investigator site 860049 Coordinator of this site? Confirm its status | Chifeng | China | Unknown status |
| Investigator site 0860038 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Investigator site 0860050 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Investigator site 0860032 Coordinator of this site? Confirm its status | Guanzhou | China | Unknown status |
| Investigator site 0860045 Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Investigator site 0860035 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Investigator site 0860031 Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Investigator site 0860040 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Investigator site 0860043 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Investigator site 860047 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Investigator site 0860028 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Investigator site 0860042 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Investigator site 0860034 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Investigator site 0860029 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Investigator site 0860048 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Investigator site 0860054 Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| Investigator site 4200010 Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Kiel | Germany | Completed |
| St. Josef-Hospital Coordinator of this site? Confirm its status | Potsdam | Germany | Completed |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Chu Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Et Universitaire De Limoges Coordinator of this site? Confirm its status | Limoges Cedex 1 | France | Recruiting |
| Hospital Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Recruiting |
| Investigator site 440026 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Investigator site 0440016 Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Investigator site 0440018 Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Investigator site 9950020 Coordinator of this site? Confirm its status | Kutaisi | Georgia | Unknown status |
| Investigator site 9950005 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Investigator site 9950004 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Investigator Site 9950003 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Investigator site 9950002 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Investigator site 9720004 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Investigator site 0810035 Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Investigator site 0810002 Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Investigator site 0810030 Coordinator of this site? Confirm its status | Fuchū | Japan | Unknown status |
| Investigator site 0810031 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Investigator site 0810065 Coordinator of this site? Confirm its status | Ginowan | Japan | Unknown status |
| Investigator site 0810066 Coordinator of this site? Confirm its status | Hakodate | Japan | Unknown status |
| Investigator site 0810058 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Investigator site 0810029 Coordinator of this site? Confirm its status | Kawagoe | Japan | Unknown status |
| Investigator site 0810026 Coordinator of this site? Confirm its status | Kodaira | Japan | Unknown status |
| Investigator site 810061 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Investigator site 0810027 Coordinator of this site? Confirm its status | Mibu | Japan | Unknown status |
| Investigator site 0810032 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Investigator site 0810003 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Investigator site 0810007 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Investigator site 0810063 Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Investigator site 0810036 Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Investigator site 0810064 Coordinator of this site? Confirm its status | Tokushima | Japan | Unknown status |
| Investigator site 0810060 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Investigator site 31 Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Michalski I Partnerzy Lekarze sp.p. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Centrum Neurologii Krzysztof Selmaj Coordinator of this site? Confirm its status | Łódź | Poland | Recruiting |
| Clinirem Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Teo Health S.A. Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Neurocity S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Coordinator of this site? Confirm its status | Timisoara | Romania | Recruiting |
| Investigator site 3810001 Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Investigator site 3810003 Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Investigator site 3810004 Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| Investigator site 070017 Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Investigator site 0070023 Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Investigator site 0070020 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Investigator site 70021 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Investigator site 0070019 Coordinator of this site? Confirm its status | Rostov-on-Don | Russia | Unknown status |
| Investigator site 0070014 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Investigator site 0070021 Coordinator of this site? Confirm its status | Saransk | Russia | Unknown status |
| Investigator site 8860013 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Investigator site 8860016 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Investigator site 8860012 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Investigator site 8860017 Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Investigator Site 3800012 Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Investigator Site 3800010 Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Unknown status |
| Investigator site 3100013 Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Investigator site 3800008 Coordinator of this site? Confirm its status | Lutsk | Ukraine | Unknown status |
| Investigator site 3800011 Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Unknown status |
| Investigator Site 0010066 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Investigator site 0010065 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Investigator site 0010072 Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Investigator site 0010032 Coordinator of this site? Confirm its status | Carlsbad | United States | Unknown status |
| Investigator site 0010057 Coordinator of this site? Confirm its status | Centennial | United States | Unknown status |
| Investigator site 0010003 Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Investigator site 0010064 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Investigator site 0010144 Coordinator of this site? Confirm its status | Coral Springs | United States | Unknown status |
| Investigator site 0010015 Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| Investigator site 0010011 Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Investigator site 0010023 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Investigator site 10147 Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Investigator site 0010068 Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Investigator site 0010059 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Investigator site 10168 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Investigator site 0010047 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Investigator site 0010007 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Investigator site 0010013 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Investigator site 10190 Coordinator of this site? Confirm its status | Pomona | United States | Unknown status |
| Investigator site 0010160 Coordinator of this site? Confirm its status | Rancho Mirage | United States | Unknown status |
| Investigator site 0010061 Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Investigator site 0010009 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Investigator site 0010071 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Investigator site 0010055 Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Investigator site 0010006 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Investigator site 900025 Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Unknown status |
| Investigator site 900021 Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Investigator site 900022 Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.