PF-06823859 for Myositis

Recruiting in Palo Alto (17 mi)

+131 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Pfizer

Must be taking: Corticosteroids, Immunosuppressants

Must not be taking: Anti-interferon beta

Disqualifiers: Cancer, Infections, Neurological disorders, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medicine called PF-06823859 for adults with muscle inflammation diseases DM and PM. The goal is to see if it can safely reduce muscle inflammation and weakness.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of their current corticosteroid or immunosuppressant medication. The protocol does not specify if other medications need to be stopped, but it seems you can continue your current treatment if it meets the study's criteria.

What makes the drug PF-06823859 unique for treating myositis?

PF-06823859, also known as Dazukibart, is a novel treatment for myositis, a condition with limited standard treatment options. Its uniqueness may lie in its specific mechanism of action or formulation, which is not detailed in the available research, but it is being compared to a placebo in clinical trials to assess its effectiveness. ^{1 2 3 4 5}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults over 18 with active Dermatomyositis (DM) or Polymyositis (PM), who are on a stable dose of corticosteroids or immunosuppressants. It's not suitable for those not meeting the specific disease criteria or unable to follow the study protocol.

Inclusion Criteria

I have active dermatomyositis or polymyositis.

I am on a stable dose of my regular medications.

I am 18 years old or older.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-06823859 or placebo via intravenous infusion every 4 weeks

48 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PF-06823859 (Monoclonal Antibodies)
• Placebo (Other)

Trial Overview The trial tests PF-06823859, given as an IV infusion every 4 weeks against a placebo, to see if it's safe and effective in treating muscle inflammation and weakness caused by DM and PM over approximately 13 months with up to 16 visits.

Participant Groups

Group I: PF-06823859 Experimental Treatment 1 Intervention

Participants will receive PF-06823859 via intravenous infusion every 4 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo via intravenous infusion every 4 weeks.

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

Findings from Research

In a 12-week open-label study involving 10 subjects with treatment-refractory dermatomyositis, tofacitinib demonstrated strong clinical efficacy, with all participants meeting the primary outcome of improved disease activity.

Half of the subjects showed moderate improvement, while the other half had minimal improvement, and significant reductions in disease severity were observed, particularly in skin symptoms, as indicated by a notable decrease in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) score.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Tofacitinib in Refractory Dermatomyositis: An Open-Label Pilot Study of Ten Patients. Paik, JJ., Casciola-Rosen, L., Shin, JY., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Myositis-specific and myositis-associated autoantibodies in a large Indian cohort of inflammatory myositis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Study of Tofacitinib in Refractory Dermatomyositis: An Open-Label Pilot Study of Ten Patients. [2022]

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

The EuroMyositis registry: an international collaborative tool to facilitate myositis research. [2021]

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

Disease-modifying effects of edasalonexent, an NF-κB inhibitor, in young boys with Duchenne muscular dystrophy: Results of the MoveDMD phase 2 and open label extension trial. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Anti-inflammatory drugs for Duchenne muscular dystrophy: focus on skeletal muscle-releasing factors. [2018]