~107 spots leftby Jul 2026

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.12345

Research Team

PC

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.
See 1 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-06823859Experimental Treatment1 Intervention
Participants will receive PF-06823859 via intravenous infusion every 4 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo via intravenous infusion every 4 weeks.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates- GlendaleGlendale, AZ
Mayo Clinic HospitalPhoenix, AZ
Mayo Clinic in Arizona - ScottsdaleScottsdale, AZ
200 UCLA Medical PlazaLos Angeles, CA
More Trial Locations
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Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4712
Patients Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Findings from Research

Myositis-specific and myositis-associated autoantibodies in a large Indian cohort of inflammatory myositis.Gupta, L., Naveen, R., Gaur, P., et al.[2021]
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.
Study of Tofacitinib in Refractory Dermatomyositis: An Open-Label Pilot Study of Ten Patients.Paik, JJ., Casciola-Rosen, L., Shin, JY., et al.[2022]
The EuroMyositis registry: an international collaborative tool to facilitate myositis research.Lilleker, JB., Vencovsky, J., Wang, G., et al.[2021]
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.Finkel, RS., Finanger, E., Vandenborne, K., et al.[2021]
Anti-inflammatory drugs for Duchenne muscular dystrophy: focus on skeletal muscle-releasing factors.Miyatake, S., Shimizu-Motohashi, Y., Takeda, S., et al.[2018]

References

Myositis-specific and myositis-associated autoantibodies in a large Indian cohort of inflammatory myositis. [2021]
Study of Tofacitinib in Refractory Dermatomyositis: An Open-Label Pilot Study of Ten Patients. [2022]
The EuroMyositis registry: an international collaborative tool to facilitate myositis research. [2021]
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]
Anti-inflammatory drugs for Duchenne muscular dystrophy: focus on skeletal muscle-releasing factors. [2018]