Study on the Long-Term Safety of Dapirolizumab Pegol for Patients with Systemic Lupus Erythematosus

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called dapirolizumab pegol for people with Systemic Lupus Erythematosus (SLE). SLE is a chronic autoimmune disease where the body’s immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body. The purpose of this study is to evaluate how well patients tolerate this treatment over an extended period.

Participants in this study will receive dapirolizumab pegol through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor participants for any side effects or adverse reactions that may occur during the treatment. The study will also assess whether the treatment can help prevent severe flare-ups of the disease, which are periods when symptoms become more intense.

The study will last for a total of 104 weeks, during which participants will have regular check-ups to track their progress and any changes in their condition. The goal is to ensure that the treatment is safe and effective for long-term use in managing Systemic Lupus Erythematosus. Participants who have completed a previous study involving a placebo may be eligible to join this extension study to continue receiving the treatment.

1 joining the study

Upon joining the study, the participant must have completed a previous study within the last four weeks. This ensures continuity in treatment and monitoring.

2 treatment with dapirolizumab pegol

The participant will receive dapirolizumab pegol, a medication administered through an intravenous infusion. This treatment is designed to evaluate its long-term safety and tolerability in individuals with systemic lupus erythematosus (SLE).

3 monitoring for adverse events

Throughout the study, the participant will be monitored for any adverse events that may occur as a result of the treatment. This includes both general adverse events and serious ones that could lead to discontinuation of the medication.

4 assessment of treatment effectiveness

The study will assess the effectiveness of the treatment in preventing severe flares of the disease. This will be evaluated at various intervals: through Week 24, Week 52, and Week 104.

Additionally, the study will measure the achievement of low disease activity and response to treatment at these same intervals.

5 completion of the study

The study is expected to conclude by April 10, 2029. The participant’s involvement will continue until the study’s end or until they choose to withdraw or are advised to discontinue for medical reasons.

Who Can Join the Study?

  • The participant must have a condition called Systemic lupus erythematosus (SLE), which is a disease where the immune system attacks the body’s own tissues.
  • The participant should be someone who, according to the study doctor, could benefit from long-term treatment with a medication called dapirolizumab pegol (DZP).
  • The participant must have completed a previous study that compared DZP with a placebo (a substance with no active medication) within the last 4 weeks before joining this study.
  • Both males and females are eligible to participate in the study.
  • The study includes participants from different age groups, including children, adults, and older adults.
  • The study may include individuals who are considered part of a vulnerable population, meaning they might need extra protection or care.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to the study medication or similar drugs.
  • Patients with active infections that require treatment with antibiotics or antiviral medications.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of cancer within the last five years, except for certain types of skin cancer.
  • Patients with severe heart disease or uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients who have received another investigational drug within the last 30 days.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who have a condition that, in the opinion of the study doctor, would make participation unsafe or affect the study results.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Azienda Ospedaliera di Padova Padua Italy
Hippokration Hospital Athens Greece
General University Hospital Of Larissa Larissa Greece
IRCCS Humanitas Research Hospital Rozzano Italy
University Of Debrecen Debrecen Hungary
Laiko General Hospital Of Athens Athens Greece
Hospital Vall d’Hebron Barcelona Spain
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Hospital Universitario da A Coruna A Coruna Galicia Spain
Virgen del Rocío University Hospital Sevilla Spain
University Hospital Cologne Cologne Germany
Odense University Hospital Odense Denmark
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Amsterdam UMC Amsterdam The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
University Hospital Jena KöR Jena Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Aalborg University Hospital Aalborg Denmark
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Region Midtjylland Aarhus Denmark
University Of Szeged Szeged Hungary
University Hospital Maastricht Maastricht The Netherlands
Rigshospitalet Copenhagen Denmark
Provita Sp. z o.o. Katowice Poland
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universita Degli Studi Di Roma La Sapienza Rome Italy
Technische Universitaet Dresden Dresden Germany
Centre hospitalier universitaire de Liege Liege Belgium
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Universitair Medisch Centrum Groningen Groningen The Netherlands
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hopital Beaujon Clichy France
Hospital Universitario Marques De Valdecilla Santander Spain
Universita Degli Studi Di Brescia Brescia Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
University General Hospital Of Heraklion Heraklion Greece
Complexo Hospitalario Universitario De Vigo Vigo Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Universitaetsklinikum Leipzig AöR Leipzig Germany
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre STRASBOURG, Alsace France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Parc Tauli Hospital Universitari Sabadell Spain
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Centre Hospitalier Le Mans Le Mans France
Krankenhaus Porz Am Rhein gGmbH Cologne Germany
Hospital Universitario Araba Vitoria Spain
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital General Universitario De Castellon Castello De La Plana Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Hospital Universitario De Canarias La Laguna Spain
San Camillo Forlanini Hospital Rome Italy
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Hospital Quironsalud Sagrado Corazon Sevilla Spain

Other Sites

Site Name City Country Status
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Pratia S.A. Skorzewo Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Reum Medica Bozena Kowalewska Marek Zawadzki Wroclaw Poland
Rmvdskdgakgwxt Ufffe Prague Czechia
Mburipkpg Iwkztfuzsw Cwcdxsek Stbelucp Stf z ossx Warsaw Poland
Pbnbvptvk Hzbnandn Bordeaux France
Cahdajo Gqkfq Sfkqlxbf Santiago De Compostela Spain
Hxjbbx Fckwuzaglm Vikzxckuhntlnyxvc Ghfj Gommern Germany
Mmjujaiyg Mofkopr gtpmd Munich Germany
Imihb Claufm Psbvo Adjofs Ksruvrt Bialystok Poland
Pjiapqyr Ptybzjqm Lvmojxaw Pygy De Hxs Mcu Pwfod Hpdpgk Poznan Poland
Hxomaewq Ueepfnsxnszez Dk Brsodka Badajoz Spain
Vbya Vbset Mgxkzkr Bzj Szekesfehervar Hungary
Rymfme Sps z oovd Lublin Poland
Synmpqng Caodwo Jhpnzdrn Dy Uplbvvn Shy Ahqjanw Ambfrh Gmplmc Galati Romania
Hxmqiosw Dn Mflgwq Merida Spain
Omlmmnpppxlgcpomyydlrvxiavzf Sckugcl Kipqguzuj Io Wttozag Dbub Uhbrxlgvejnc Mwqjiecpui Iv Kvqbwf Mfuwvscmvqcotrx W Pfcsmdyb Poznan Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
07.09.2021
Bulgaria Bulgaria
Not recruiting
07.09.2021
Czechia Czechia
Not recruiting
07.09.2021
Denmark Denmark
Not yet recruiting
07.09.2021
France France
Not yet recruiting
07.09.2021
Germany Germany
Recruiting
07.09.2021
Greece Greece
Recruiting
07.09.2021
Hungary Hungary
Not recruiting
07.09.2021
Italy Italy
Recruiting
07.09.2021
Poland Poland
Recruiting
07.09.2021
Romania Romania
Not recruiting
07.09.2021
Spain Spain
Recruiting
07.09.2021
The Netherlands The Netherlands
Not yet recruiting
07.09.2021

Trial locations

Dapirolizumab Pegol (DZP) is a medication being studied for its long-term safety and tolerability in patients with Systemic Lupus Erythematosus (SLE). This medication is designed to help manage the symptoms of SLE, which is an autoimmune disease where the body’s immune system attacks its own tissues. The study aims to understand how well patients can tolerate this treatment over an extended period and to monitor any potential side effects.

Investigated Diseases:

Systemic lupus erythematosus (SLE) – This is an autoimmune disease where the body’s immune system mistakenly attacks healthy tissue. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, rash, and fever, which can vary in severity and may come and go. The disease progresses with periods of flares, where symptoms worsen, and remissions, where symptoms improve. Over time, SLE can lead to damage in the affected organs and tissues. The exact cause of SLE is unknown, but it is believed to involve a combination of genetic, environmental, and hormonal factors.

Trial ID:
2023-506368-14-00
Protocol code:
SL0046
NCT ID:
NCT04976322
Trial Phase:
Therapeutic confirmatory (Phase III)

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