PF-06823859 for Systemic Lupus Erythematosus

Not currently recruiting at 42 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Disqualifiers: Cancer, Cardiovascular event, Severe infection, others

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

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called PF-06823859 (Dazukibart) for people with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE) who have skin symptoms. Participants will receive either the treatment or a placebo (a substance with no active drug) to assess the treatment's impact on their skin symptoms over time. The trial seeks adults diagnosed with CLE or SLE for at least three months who show noticeable skin symptoms. Participants will engage in the trial for about 65 weeks, with regular treatments and follow-up visits. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in lupus 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 trial coordinators or your doctor.

Is there any evidence suggesting that PF-06823859 is likely to be safe for humans?

Research has shown that PF-06823859 was safe in earlier studies, meaning most participants did not experience major problems. These studies did not identify any serious side effects, prompting further testing for conditions like lupus, where it might alleviate skin symptoms. While more research is needed to confirm its safety for everyone, these early results are encouraging for potential trial participants. ^{1 2 3 4 5}

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

Unlike the standard treatments for systemic lupus erythematosus, which often include immunosuppressants and corticosteroids, PF-06823859 offers a new approach by targeting the body's immune response more precisely. This investigational drug is a monoclonal antibody that specifically inhibits a protein involved in the inflammatory process, potentially reducing symptoms with fewer side effects. Researchers are excited about PF-06823859 because it could provide more targeted relief for patients, potentially improving their quality of life without the broad immune suppression that current treatments entail.

What evidence suggests that PF-06823859 might be an effective treatment for lupus?

Research has shown that PF-06823859, a specially designed antibody, may help treat lupus with skin symptoms. In this trial, participants will receive either PF-06823859 or a placebo. Previous studies have found that treatments targeting IFNβ, a protein linked to inflammation, can greatly reduce disease activity. This suggests that PF-06823859 might help lessen lupus symptoms. Early results indicate that the treatment is generally well-tolerated, making it a possible option for people with skin or systemic lupus. However, ongoing research will provide more information on its effectiveness and safety. ^{2 3 5 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Adults over 18 with active CLE or SLE and skin symptoms, a CLASI-A score of at least 8, weighing between 40-130 kg can join. They must have confirmed lupus skin manifestations for at least 3 months and be willing to undergo study procedures like skin biopsies. Exclusions include recent serious cardiovascular events, severe infections, other autoimmune diseases that could affect results, certain cancers within the last five years.

Inclusion Criteria

Participant has adequate intravenous infusion access per investigator's judgement

My weight is between 40 kg and 130 kg.

I have active lupus affecting my skin for at least 3 months with a CLASI-A score of 8 or more.

Exclusion Criteria

I have severe lupus affecting my kidneys, needing strong medication.

I have not had a major heart or stroke event, or serious lung blood clot in the last 6 months.

I haven't had a serious infection or taken antibiotics in the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment Phase 1

Participants receive the study medication or placebo every 4 weeks for 12 weeks

12 weeks

3 visits (in-person)

Treatment Phase 2

Participants continue to receive the study medication or placebo every 8 weeks for 36 weeks

36 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PF-06823859

Trial Overview The trial is testing PF-06823859 against a placebo in adults with lupus affecting the skin. Participants will receive treatments via intravenous infusion. The goal is to see if PF-06823859 improves their condition compared to those who receive no drug (placebo). The study includes initial treatment, long-term extension period and follow-up totaling approximately 65 weeks.

How Is the Trial Designed?

Group I: Group 1 Experimental Treatment 1 Intervention

PF-06823859

Group II: Group 2 Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05879718

NCT05879718 | A Study to Learn About the ... The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314112/

Results From 2 Randomized, Double‐Blind, Phase 1 Studies A double‐blind, randomized, placebo‐controlled Phase 3 study evaluating the safety and efficacy of dazukibart in patients with active idiopathic ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-of-pf-06823859-for-adults-with-active-cutaneous-or-systemic-lupus-erythematosus-with-skin-symptoms/

Study of PF-06823859 for Adults with Active Cutaneous or ... This clinical trial tests the efficacy of PF-06823859, a humanised IgG1k monoclonal antibody, in adults with active Cutaneous or Systemic Lupus ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT05879718

A Study to Learn About the Study Medicine (PF-06823859) in ... The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39798982/

Efficacy, safety, and target engagement of dazukibart, an ... Dazukibart resulted in a pronounced reduction in disease activity and was generally well tolerated, supporting IFNβ inhibition as a highly promising ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33352008/

Safety, Tolerability, and Pharmacokinetics of PF-06823859, ... PF-06823859 demonstrated an acceptable safety, tolerability, and PK profile that supports clinical development for treating disorders associated with increased ...

7. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.887

Safety, Tolerability, and Pharmacokinetics of PF‐06823859 ... In conclusion, PF-06823859 demonstrated an acceptable safety, tolerability, and PK profile that supports clinical development for treating ...