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Monoclonal Antibodies

Dapirolizumab Pegol for Lupus

Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) until safety follow-up (up to week 110)
Awards & highlights

Study Summary

This trial will evaluate if dapirolizumab pegol is safe and tolerated when taken long-term by people with autoimmune diseases.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, generally such trials monitor for any adverse reactions including but not limited to allergic responses, infections due to immune suppression, organ-specific inflammation, or other drug-related complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) until safety follow-up (up to week 110)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) until safety follow-up (up to week 110) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of serious treatment-emergent adverse events during the study
Incidence of treatment-emergent adverse events (TEAEs) during the study
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
Secondary outcome measures
Achievement of BICLA response at Week 104
Achievement of BICLA response at Week 24
Achievement of BICLA response at Week 52
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dapirolizumab pegolExperimental Treatment1 Intervention
Subjects will receive dapriolizumab pegol throughout the Treatment Period.

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
20,676 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
205 Previous Clinical Trials
44,203 Total Patients Enrolled

Media Library

Dapirolizumab Pegol (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04976322 — Phase 3
Lupus Research Study Groups: Dapirolizumab pegol
Lupus Clinical Trial 2023: Dapirolizumab Pegol Highlights & Side Effects. Trial Name: NCT04976322 — Phase 3
Dapirolizumab Pegol (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04976322 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many distinct facilities are overseeing this clinical trial?

"Currently, this trial is active at 18 sites, with locations in Trois-rivieres, Trois-Rivières, Tampa, and other cities."

Answered by AI

Are investigators still looking for new trial participants?

"No, the trial is not currently recruiting patients according to the latest update on clinicaltrials.gov. The study was posted on 7/27/2021 and last updated on 10/27/2022. Although this study isn't looking for patients, there are 126 other studies that are."

Answered by AI

What are the organizers of this clinical trial hoping to achieve?

"The primary objective of this study, as stated by the sponsor UCB Biopharma SRL, is to measure the incidence of treatment-emergent adverse events (TEAEs) that lead to permanent dapirolizumab pegol discontinuation. This will be done over a From Baseline (Day 1) until Safety Follow-Up (up to Week 110) interval. Additionally, the study will evaluate secondary outcomes including Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104 and Achievement of BICLA response at Week 24 and Week 104."

Answered by AI

Are there any similar medical studies to Dapirolizumab pegol?

"As of now, there are two Dapirolizumab pegol clinical trials underway. Out of these two, one is in Phase 3. Most of the 345 trial locations for this medication are in Kwei-san Hsiang, Kentucky."

Answered by AI

Are there any Dapirolizumab pegol side effects that patients should worry about?

"Dapirolizumab pegol is in Phase 3 of clinical trials, which is the highest level of evidence for both efficacy and safety."

Answered by AI

Who else is applying?

What site did they apply to?
Sl0046 50418
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
2021. "A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04976322.
All > Systemic Lupus Erythematosus > Lupus
~487 spots leftby Apr 2029
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