SL0046
SL0046
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
Brief summary
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
Medical Condition
Systemic lupus erythematosus
Min. Age
16
Years
Max. Age
-
Who Can Join?
All
Status
Enrolling by invitation
Inclusion criteria
- The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment - The participant completed one of the placebo controlled (PBO-controlled) parent studies within 4 weeks prior to entry to this study
Exclusion criteria
- 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
Study Medication Description
Study Medication:
Dapirolizumab pegol
Other Descriptive Name:
dapirolizumab pegol
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
July 2021
Actual Start Date of Enrollment
April 2029
Planned Study Completion Date
General Information
Study ID:
SL0046
EudraCT Number:
2019-003409-83
CT.gov Number:
NCT04976322
Phase:
Phase 3