Study on the Effectiveness and Safety of Dapirolizumab Pegol for Patients with Moderate to Severe Systemic Lupus Erythematosus

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What is this study about?

This clinical trial is focused on studying the effects of a medication called dapirolizumab pegol in people with systemic lupus erythematosus (SLE)</b), a condition where the immune system attacks the body's own tissues, causing inflammation and damage. The study aims to determine if dapirolizumab pegol, when added to standard treatments, can help improve the symptoms of moderate to severe SLE. Participants in the study will receive either dapirolizumab pegol or a placebo, which looks like the medication but does not contain the active substance.

The study will take place over a period of time, during which participants will receive the treatment through an infusion, which means the medication is given directly into a vein. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to see if the medication can provide a long-term improvement in the disease activity of SLE.

In addition to dapirolizumab pegol, participants will continue their usual standard of care treatments, which may include medications like antimalarials, corticosteroids, and immunosuppressants. These are commonly used to manage SLE symptoms. The study will help researchers understand if adding dapirolizumab pegol to these treatments can offer additional benefits for people living with SLE.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the investigational medication, dapirolizumab pegol, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

2 treatment administration

The participant will receive dapirolizumab pegol or placebo as a solution for infusion. This means the medication is given directly into a vein through an intravenous (IV) line.

The frequency and dosage of the infusion will be determined by the study protocol and will be administered at regular intervals throughout the study period.

3 monitoring and assessments

Regular monitoring will occur to assess the participant’s response to the treatment. This includes evaluating the disease activity using specific criteria and scales designed for systemic lupus erythematosus (SLE).

Assessments will be conducted at various time points, including weeks 12, 24, and 48, to measure the effectiveness and safety of the treatment.

4 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation will be conducted to determine the overall impact of the treatment on the participant’s condition.

This evaluation will include a review of any adverse events experienced during the study and the participant’s overall health status.

5 follow-up

After completing the treatment phase, follow-up visits may be scheduled to monitor the participant’s health and any long-term effects of the treatment.

Who Can Join the Study?

  • The participant must be at least 16 years old at the time of signing the consent form.
  • The participant should have moderate to severe disease activity due to ongoing active systemic lupus erythematosus (SLE) or a sudden worsening of SLE, even with stable standard treatment.
  • The participant must have been diagnosed with SLE at least 24 weeks before the screening visit by a qualified doctor.
  • The participant should meet the 2019 classification criteria for SLE set by the European League Against Rheumatism and the American College of Rheumatology.
  • There must be serological evidence for SLE at screening, shown by at least one of the following:
    • Evidence of anti-dsDNA antibodies, which are specific proteins found in the blood.
    • Low levels of complement proteins C3 or C4, which are part of the immune system.
    • Presence of antinuclear antibodies with a specific titer, along with at least one of the following SLE-related antibodies:
      • Anti-Smith (anti-Sm) antibodies
      • Anti-Sjögren’s syndrome antibodies (Anti-SSA/Ro or Anti-SSB/La)
      • Historical evidence of anti-dsDNA antibodies
      • Anti-ribonucleoprotein (RNP) antibodies
  • The participant must have moderate to severe active disease, defined by specific scores on the British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) and the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at screening and baseline visits.
  • The participant should be receiving stable doses of standard treatment, which may include:
    • Antimalarial treatment with or without corticosteroids and/or immunosuppressants
    • Only corticosteroids and/or immunosuppressants if antimalarial treatment is not suitable due to intolerance, lack of effectiveness, contraindications, or unavailability

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to similar medications.
  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments recently that could affect the study results.
  • Patients with a history of substance abuse that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients with certain infections that could affect their participation in the study.
  • Patients who have had a recent surgery that might impact the study.
  • Patients with a history of certain mental health conditions that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Azienda Ospedaliera di Padova Padua Italy
General University Hospital Of Larissa Larissa Greece
IRCCS Humanitas Research Hospital Rozzano Italy
Laiko General Hospital Of Athens Athens Greece
Hospital Vall d’Hebron Barcelona Spain
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
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
Centre Hospitalier Universitaire De Montpellier Montpellier France
Aalborg University Hospital Aalborg Denmark
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Region Midtjylland Aarhus Denmark
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
Hospital Universitario Marques De Valdecilla Santander Spain
Universita Degli Studi Di Brescia Brescia 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
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Parc Tauli Hospital Universitari Sabadell Spain
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
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
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
University Hospitals Pitie Salpetriere Charles Foix Paris France
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain

Other Sites

Site Name City Country Status
Rheumazentrum Greifswald Greifswald Germany
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Pratia S.A. Skorzewo Poland
Mxarnnozf Iokkbccgav Cwoykots Stftdfen Slp z ojlb Warsaw Poland
Pzpyjfwwq Hzfzuwks Bordeaux France
Cdbpuiu Glygz Shsreeee Santiago De Compostela Spain
Hdyuvt Fbomukgucs Vjbmxzkhivdlbukxf Gknn Gommern Germany
Mrnbgnpww Muewvln gusbu Munich Germany
Rlrrwabmnfd Szxs Bphamf Kimxlfvqnwp Mshjz Zibeqmxf Wroclaw Poland
Hlnvwulu Utinlkjdbpxmh Dc Blvtoam Badajoz Spain
Rruqsu Sxj z obrf Lublin Poland
Hrrqzilf Do Mdfmba Merida Spain
Ojtpgalrfliayrekswlpxpwumcbz Snxcgnf Kjqqoefxl Ix Wxlaenh Dbox Uswzkxbblppx Meqmhbtiby Iq Ksbvwz Mfwmyjhjrxtpmwh W Prjbgpaq Poznan Poland
Mnhslzed Cfijcpx Hfqjqgwke Patpz Lofjiiuisll Poznan Poland
Acbeaamhtp Pmtovwbl Hrqbjhok Di Pazog Le Kremlin-Bicetre France
Lqc Hijpjkiu Ubygvangsldhxe Dl Stlzuxoikz STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
16.09.2024
Denmark Denmark
Recruiting
16.09.2024
France France
Recruiting
16.09.2024
Germany Germany
Recruiting
16.09.2024
Greece Greece
Recruiting
16.09.2024
Italy Italy
Recruiting
16.09.2024
Poland Poland
Recruiting
16.09.2024
Spain Spain
Recruiting
16.09.2024
The Netherlands The Netherlands
Recruiting
16.09.2024

Trial locations

Dapirolizumab Pegol (DZP) is being studied to see if it can help people with moderately to severely active systemic lupus erythematosus. It is used in addition to the standard treatments that patients are already receiving. The goal is to find out if this medication can provide a significant and lasting improvement in the symptoms of the disease.

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 is characterized by periods of illness, called flares, and periods of remission when 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:
2023-508191-11-00
Protocol code:
SL0044
Trial Phase:
Therapeutic confirmatory (Phase III)

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