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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

Study Dates

July 2021

Actual Start Date of Enrollment

December 2026

Planned Study Completion Date

General Information

Study ID:
SL0046
EudraCT Number:
2019-003409-83
CT.gov Number:
NCT04976322
Phase:
Phase 3

Interested in enrolling in our study?

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