Long-term safety of dapirolizumab pegol in people with lupus
Tests dapirolizumab pegol's long-term safety in people with systemic lupus erythematosus.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
Key facts
- Where
- Brescia, Catania, Ferrara, Genoa, Milan, Modena, Monza, Padova, Pisa, Rome, Rozzano, and Udine, ItalySee the 17 sites
- Phase
- Phase 3
Where in Italy
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini CtoMilan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedale Universita PadovaPadova, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- San Camillo Forlanini HospitalRome, ItalyTaking people
- Università Campus Bio-Medico di RomaRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UCB Biopharma SRL
- Trial code
- NCT04976322EU 2023-506368-14-00
- Record updated
- 15 October 2026
- Original description
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.Read full original descriptionShow less
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
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
Inclusion: 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.
Exclusion: 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.