Dapirolizumab Pegol for Lupus

Recruiting in Palo Alto (17 mi)

+109 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: UCB Biopharma SRL

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial aims to evaluate the safety and tolerability of dapirolizumab pegol, a medication that helps manage health conditions by calming overactive immune responses in patients needing ongoing treatment.

Eligibility Criteria

This trial is for individuals who have completed a previous study on systemic lupus erythematosus within the last 4 weeks and could benefit from further treatment. Those with life-threatening conditions, ongoing cancer, or medical/psychiatric issues that may compromise their participation are excluded.

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

Participant Groups

The study is focused on assessing the long-term safety and tolerability of a medication called dapirolizumab pegol in patients with systemic lupus erythematosus to see how well they handle extended use of this drug.

1Treatment groups

Experimental Treatment

Group I: Dapirolizumab pegolExperimental Treatment1 Intervention

Subjects will receive dapriolizumab pegol throughout the Treatment Period.