What side effects are associated with this type of intervention?

Common treatments for Lupus, particularly monoclonal antibodies like dapirolizumab pegol, often target immune system components to reduce inflammation. Known side effects of these treatments can include infusion reactions, increased susceptibility to infections, and the development of antidrug antibodies, which may reduce efficacy and cause adverse reactions. Other potential side effects include hyperglycemia, bone loss, neuropsychiatric effects, and gastrointestinal issues. It is important for patients to discuss these risks with their healthcare provider to manage and mitigate potential adverse effects effectively.

What prior FDA approvals exist?

The FDA has approved several biologics for the treatment of systemic lupus erythematosus (SLE). One notable example is Belimumab, a monoclonal antibody that targets B-lymphocyte stimulator (BLyS) to reduce the activity of B cells, which are implicated in lupus. Another approved treatment is Anifrolumab, which targets the type I interferon receptor, thereby reducing inflammation and immune system activity. These treatments, like Dapirolizumab Pegol, aim to modulate the immune system to manage lupus symptoms and prevent flare-ups.

What other types of research exist?

Promising alternatives to Dapirolizumab Pegol for Lupus patients include Belimumab (a monoclonal antibody targeting B-lymphocyte stimulator) and Anifrolumab (a monoclonal antibody targeting the type I interferon receptor). Both have shown efficacy in reducing disease activity in SLE patients and are approved for use. Additionally, Rituximab (an anti-CD20 monoclonal antibody) continues to be explored for its potential benefits in SLE treatment.

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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

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) until safety follow-up (up to week 110)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Achievement of BICLA response at Week 104

Achievement of BICLA response at Week 24

Achievement of BICLA response at Week 52

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dapirolizumab pegolExperimental Treatment1 Intervention

Subjects will receive dapriolizumab pegol throughout the Treatment Period.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lupus, such as monoclonal antibodies like Dapirolizumab Pegol, work by targeting specific components of the immune system to reduce activity and inflammation. Dapirolizumab Pegol targets the CD40 ligand, which plays a crucial role in the activation of immune cells. By inhibiting this ligand, the treatment aims to decrease the overactive immune response that characterizes Lupus. Other treatments may target inflammatory cytokines, B cells, or T cells to achieve similar effects. These mechanisms are vital for Lupus patients as they help manage symptoms, prevent organ damage, and improve quality of life by controlling the underlying immune dysfunction.

[Neuropsychiatric Systemic Lupus Erythematosus].The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.Advances in drug therapy for systemic lupus erythematosus.