Dapirolizumab Pegol for Lupus

Recruiting at 111 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

760 Participants Needed

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.

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.

What data supports the effectiveness of the drug Dapirolizumab Pegol for treating lupus?

Research shows that Dapirolizumab Pegol, which blocks a protein called CD40L involved in immune responses, has been well tolerated and led to improvements in lupus disease activity in clinical trials. It increased the likelihood of patients responding positively to treatment, suggesting it could be an effective option for managing lupus. ^{1 2 3 4 5}

Is Dapirolizumab Pegol safe for humans?

Dapirolizumab Pegol has been tested in both healthy individuals and patients with systemic lupus erythematosus (SLE) and was generally well tolerated. Importantly, it did not show the increased risk of blood clots that was seen with a similar treatment in the past. ^{1 2 3 4 5}

What makes the drug Dapirolizumab Pegol unique for treating lupus?

Dapirolizumab Pegol is unique because it blocks the CD40 ligand, which is involved in activating immune cells, potentially reducing inflammation in lupus without the increased risk of blood clots seen with similar treatments. It is a PEGylated (attached to polyethylene glycol) antibody fragment, which may improve its stability and reduce side effects. ^{1 2 3 4 5}

Research Team

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

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

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. England 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. [2018]

2. England 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. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response for Dapirolizumab Pegol From a Phase 2b Trial in Patients With Systemic Lupus Erythematosus. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus. [2022]

5. England 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. [2018]