Dapirolizumab Pegol for Lupus

Enrolling by invitation at 136 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Disqualifiers: Life-threatening condition, Ongoing malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called dapirolizumab pegol (a pegylated anti-CD40L antibody) to determine its safety and manageability for people with lupus. Lupus is an autoimmune disease where the immune system attacks the body's tissues, causing inflammation and pain. The study seeks participants who have recently completed a related study and might benefit from continued treatment with this medication. Participants must not have any serious health issues that could interfere with the trial. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking lupus therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that dapirolizumab pegol is likely to be safe for humans?

Research has shown that dapirolizumab pegol has a good safety record. In one study, single doses of this medication were well tolerated by both healthy individuals and those with systemic lupus erythematosus (SLE), with no major safety issues reported. Another study found that repeated doses were also well tolerated, and participants experienced improvements in their condition. Although more research is needed to fully understand long-term safety, current studies suggest that dapirolizumab pegol is generally well tolerated by people with lupus. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Unlike the standard lupus treatments, which often include corticosteroids and immunosuppressants that broadly dampen the immune system, Dapirolizumab Pegol is unique because it specifically targets and blocks CD40 ligand, a molecule involved in the activation of the immune system. This targeted approach has the potential to reduce the immune system's attack on the body more precisely, potentially leading to fewer side effects. Researchers are excited about this treatment as it represents a more tailored approach to managing lupus, offering hope for improved efficacy and safety compared to existing therapies.

What evidence suggests that dapirolizumab pegol might be an effective treatment for lupus?

Research has shown that dapirolizumab pegol might help treat lupus by targeting a specific part of the immune system. This action reduces the activity of certain immune cells, decreasing the production of harmful antibodies—a major issue in lupus. In earlier studies, patients who took dapirolizumab pegol experienced symptom improvements and tolerated the treatment well over 24 weeks. Although more research is needed, these results suggest that dapirolizumab pegol could be a promising treatment option for people with lupus. ^{1 2 3 4 5}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dapirolizumab pegol treatment to evaluate long-term safety and tolerability

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Open-label extension

Participants may continue to receive dapirolizumab pegol treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Dapirolizumab Pegol

Trial Overview 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.

How Is the Trial Designed?

Group I: Dapirolizumab pegol Experimental Treatment 1 Intervention

Subjects will receive dapriolizumab pegol throughout the Treatment Period.

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Published Research Related to This Trial

CDP7657, a PEGylated anti-CD40L antibody fragment, was well tolerated in a phase I study involving 28 healthy individuals and 17 patients with systemic lupus erythematosus (SLE), with most adverse events being mild or moderate.

The pharmacokinetics of CDP7657 were predictable and dose-proportional, and there were no significant safety concerns, supporting its potential for further investigation as a treatment for SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus erythematosus. Tocoian, A., Buchan, P., Kirby, H., et al.[2018]

CDP7657, a high affinity PEGylated anti-CD40L antibody fragment, effectively inhibited immune responses in Cynomolgus monkeys without causing thrombotic events, unlike the previously tested hu5c8 antibody.

The study demonstrated that anti-CD40L antibodies lacking a functional Fc region, such as CDP7657, do not activate platelets and retain their therapeutic efficacy, suggesting a safer alternative for treating systemic lupus erythematosus and other autoimmune diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CDP7657, an anti-CD40L antibody lacking an Fc domain, inhibits CD40L-dependent immune responses without thrombotic complications: an in vivo study. Shock, A., Burkly, L., Wakefield, I., et al.[2018]

In a 32-week study involving 24 patients with systemic lupus erythematosus (SLE), dapirolizumab pegol was found to be safe, with no serious adverse events reported and only mild to moderate side effects that resolved without intervention.

The treatment showed promising efficacy, with 46% of patients on dapirolizumab pegol achieving a significant clinical response compared to only 14% in the placebo group, indicating its potential as a biological treatment for SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles. Chamberlain, C., Colman, PJ., Ranger, AM., et al.[2018]

Dapirolizumab pegol, currently in phase 3 trials for systemic lupus erythematosus (SLE), shows dose-proportional pharmacokinetics and effectively increases the likelihood of patients transitioning from 'Nonresponder' to 'Responder' based on the British Isles Lupus Assessment Group criteria.

The study found that maintaining higher concentrations of dapirolizumab pegol is crucial for sustaining treatment response, as the effective concentration needed to prevent relapse ('Responder' to 'Nonresponder') is significantly higher than that required to achieve an initial response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response for Dapirolizumab Pegol From a Phase 2b Trial in Patients With Systemic Lupus Erythematosus. Acharya, C., Magnusson, MO., Vajjah, P., et al.[2023]

Dapirolizumab pegol (DZP) showed improvements in clinical and immunological outcomes for patients with moderately to severely active systemic lupus erythematosus (SLE) after 24 weeks, although the primary dose-response relationship was not statistically significant.

DZP was well tolerated with low incidences of serious adverse events, suggesting it is a safe option for SLE treatment, warranting further investigation into its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus. Furie, RA., Bruce, IN., Dörner, T., et al.[2022]

Citations

1. investors.biogen.com investors.biogen.com/news-releases/news-release-details/biogen-present-additional-results-phase-3-study-dapirolizumab

Biogen to Present Additional Results from Phase 3 Study of ... Dapirolizumab pegol inhibits CD40L signaling which has been shown to reduce B cell activation and autoantibody production, mitigate type 1 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9194804/

Phase 2, randomized, placebo-controlled trial of ... DZP appeared to be well tolerated, and patients exhibited improvements across multiple clinical and immunological measures of disease activity after 24 weeks ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25784719/

First-in-human trial of the safety, pharmacokinetics and ... Single doses of CDP7657 showed predictable PK in healthy individuals and patients with SLE and were well tolerated, with no safety signals of concern.

4. ard.bmj.com ard.bmj.com/content/early/2017/08/04/annrheumdis-2017-211388?versioned=true

Repeated administration of dapirolizumab pegol in a ... Dapirolizumab pegol could be an effective biological treatment for SLE. Further studies are required to address efficacy and safety.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1568997220302433

Rediscovering the role of the CD40–CD40L pathway in ... UCB and Biogen announce topline results from a phase 2b study of dapirolizumab pegol in systemic lupus erythematosus. https://investors.biogen.com/news ...