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Study of Dapirolizumab Pegol for Systemic Lupus Erythematosus

This study is looking at the long-term safety of a drug called dapirolizumab pegol for people with Systemic Lupus Erythematosus (SLE), an autoimmune disease. Researchers want to see how often side effects happen and how serious they are over time. To join, you must have already completed a previous study involving dapirolizumab pegol and your doctor must believe you would benefit from continued treatment. The study aims to enroll about 760 participants. The study is ongoing, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive dapirolizumab pegol. It plans to enroll 760 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety up to Week 110 after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04976322

A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

Enrolling by Invitation
PHASE3Ages 16+InterventionalTreatment
UCB Biopharma SRL
~760 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Dapirolizumab pegol

At a glance

Recruiting sites
0 of 119 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events (TEAEs) during the study
Measured over From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
+2 more outcomes measured

Conditions

Systemic Lupus Erythematosus

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Systemic Lupus Erythematosus

Where it's being run

119 sites across 42 states
Poland11
China10
Florida7
Colombia7
Argentina6
Germany6
Mexico6
Arizona4

Study leadership

  • UCB Cares · STUDY_DIRECTOR · 001 844 599 2273 (UCB)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

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

What this trial measures

  • Incidence of treatment-emergent adverse events (TEAEs) during the studyFrom Baseline (Day 1) until Safety Follow-Up (up to Week 110)

    Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

  • Incidence of serious treatment-emergent adverse events during the studyFrom Baseline (Day 1) until Safety Follow-Up (up to Week 110)

    A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above

  • Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuationFrom Baseline (Day 1) until Safety Follow-Up (up to Week 110)

    Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, and leading to permanent drug discontinuation whether or not these events are related to study treatment.