NCT04976322Enrolling by invitationPhase 3
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 760 (estimated)
- First submitted
- 14 Jul 2021
- Start date
- 27 Jul 2021
- Primary completion date
- 7 Aug 2030
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Lupus (SLE)
- NCT number
- NCT04976322
- EU CT number
- 2023-506368-14-00
- EudraCT number
- 2019-003409-83
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 760
- From 27 Jul 2021 to the primary completion date, 7 Aug 2030
- 184 sites in 27 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.
Other illness
- \- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study
Who the study is looking for
- The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment
- The participant completed one of the parent studies within 4 weeks prior to entry to this study
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (184)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sl0046 60002 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Sl0046 60029 Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Sl0046 60022 Coordinator of this site? Confirm its status | Quilmes | Argentina | Unknown status |
| Sl0046 60003 Coordinator of this site? Confirm its status | Quilmes | Argentina | Unknown status |
| Sl0046 60011 Coordinator of this site? Confirm its status | San Juan | Argentina | Unknown status |
| Sl0046 60014 Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| CHU de Liège 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 |
| Diagnostic Consultative Center Sveti Georgi EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Sl0046 50374 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Sl0046 50337 Coordinator of this site? Confirm its status | Edmonton AB | Canada | Unknown status |
| Sl0046 50259 Coordinator of this site? Confirm its status | Rimouski | Canada | Unknown status |
| Sl0046 50045 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Sl0046 60018 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Sl0046 60015 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Sl0046 20128 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Sl0046 20291 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Sl0046 20019 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sl0046 20290 Coordinator of this site? Confirm its status | Guilin | China | Unknown status |
| Sl0046 20020 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Sl0046 20346 Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
| Sl0046 20204 Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Sl0046 20136 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Sl0046 20025 Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Sl0046 20180 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Sl0046 20273 Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
| Sl0046 20132 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Sl0046 60019 Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| Sl0046 60013 Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| Sl0046 60027 Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Sl0046 60006 Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Sl0046 60016 Coordinator of this site? Confirm its status | Bucaramanga | Colombia | Unknown status |
| Sl0046 60007 Coordinator of this site? Confirm its status | Chía | Colombia | Unknown status |
| Sl0046 60031 Coordinator of this site? Confirm its status | Montería | Colombia | Unknown status |
| Revmatologicky Ustav Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Krankenhaus Porz am Rhein gGmbH Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Helios Fachklinik Vogelsang-Gommern GmbH Coordinator of this site? Confirm its status | Gommern | Germany | Recruiting |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universitaetsklinikum Leipzig Aor Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Medicover GmbH Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Region Nordjylland Coordinator of this site? Confirm its status | Aalborg | Denmark | Not yet recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Not yet recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Not yet recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Not yet recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | 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 General Universitario De Castellon Coordinator of this site? Confirm its status | Castello De La Plana | Spain | Recruiting |
| Futuremeds Spain S.L. Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital de Mérida Coordinator of this site? Confirm its status | Mérida | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| University Hospital Of Canary Islands Coordinator of this site? Confirm its status | San Cristobal De La Laguna | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Clínica Gaias - Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Quironsalud Infanta Luisa Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Quironsalud Sagrado Corazon Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Complexo Hospitalario Universitario De Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Hospital Universitario Araba Coordinator of this site? Confirm its status | Vitoria | Spain | Recruiting |
| Pellegrin Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Not yet recruiting |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Not yet recruiting |
| Hippokration Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Recruiting |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Recruiting |
| Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Coordinator of this site? Confirm its status | Budapest IX | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Vita Verum Medical Bt. Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Università Campus Bio-Medico di Roma Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| San Camillo Forlanini Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Sl0046 20287 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Sl0046 20108 Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Sl0046 20104 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Sl0046 50317 Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Sl0046 50250 Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Unknown status |
| Sl0046 50249 Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Sl0046 50271 Coordinator of this site? Confirm its status | León | Mexico | Unknown status |
| Sl0046 50252 Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Sl0046 50251 Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
| Universiteit Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Not yet recruiting |
| Sl0046 60009 Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Sl0046 60023 Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Sl0046 20182 Coordinator of this site? Confirm its status | Davao City | Philippines | Unknown status |
| Sl0046 20181 Coordinator of this site? Confirm its status | Makati | Philippines | Unknown status |
| INTER CLINIC Piotr Adrian Klimiuk Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Provita Sp z o o Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Reumed Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Ortopedyczno - Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Medyczne Centrum Hetmańska Piotr Leszczyński Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Klinika Reuma Park Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Reum Medica Bozena Kowalewska Marek Zawadzki Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Sl0046 50671 Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Unknown status |
| Spitalul Clinic Judetean De Urgenta Sf. Apostol Andrei Galati Coordinator of this site? Confirm its status | Galati | Romania | Completed |
| Sl0046 40461 Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Sl0046 40730 Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Sl0046 40393 Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Sl0046 40392 Coordinator of this site? Confirm its status | Novi Sad | Serbia | Unknown status |
| Sl0046 20113 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Sl0046 20142 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Sl0046 20095 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Sl0046 20082 Coordinator of this site? Confirm its status | Taiyuan | Taiwan | Unknown status |
| Sl0046 50368 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Sl0046 50058 Coordinator of this site? Confirm its status | Avondale | United States | Unknown status |
| Sl0046 50050 Coordinator of this site? Confirm its status | Beckley | United States | Unknown status |
| Sl0046 50738 Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Sl0046 50383 Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Sl0046 50140 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Sl0046 50239 Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| Sl0046 50366 Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Sl0046 50238 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Sl0046 50699 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Sl0046 50418 Coordinator of this site? Confirm its status | Colleyville | United States | Unknown status |
| Sl0046 50339 Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Sl0046 50219 Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Sl0046 50362 Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Sl0046 50662 Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Sl0046 50015 Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Sl0046 50147 Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Sl0046 50474 Coordinator of this site? Confirm its status | Hopkinsville | United States | Unknown status |
| Sl0046 50240 Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| Sl0046 50001 Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Sl0046 50285 Coordinator of this site? Confirm its status | Lake Charles | United States | Unknown status |
| Sl0046 50275 Coordinator of this site? Confirm its status | La Palma | United States | Unknown status |
| Sl0046 50273 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Sl0046 50264 Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| Sl0046 50681 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Sl0046 50660 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Sl0046 50334 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Sl0046 50059 Coordinator of this site? Confirm its status | Ormond Beach | United States | Unknown status |
| Sl0046 50052 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Sl0046 50324 Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Sl0046 50316 Coordinator of this site? Confirm its status | San Leandro | United States | Unknown status |
| Sl0046 50329 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Sl0046 50698 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Sl0046 50328 Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.