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Monoclonal Antibodies

PF-06823859 for Myositis

Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female adults (≥18 years old)
Active dermatomyositis (DM) or polymyositis (PM) with age of onset
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 and 52 weeks in the us only
Awards & highlights
Pivotal Trial

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of PF-06823859 may include reactions at the infusion site, increased risk of infections due to immune system suppression, fatigue, headache, nausea, but specifics will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have active dermatomyositis or polymyositis.
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I am on a stable dose of my regular medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 52 weeks in the us only
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 and 52 weeks in the us only for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Moderate change in Total Improvement Score (TIS)
Secondary study objectives
Change from baseline in 5-D Itch Scale Score
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM)
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
+6 more

Side effects data

From 2022 Phase 1 trial • 13 Patients • NCT05037409
20%
Intervertebral disc protrusion
20%
Road traffic accident
20%
Vaccination site pain
20%
Abdominal pain lower
20%
Thermal burn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: PF-06823859 300 mg
Cohort 2: PF-06823859 900 mg
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06823859
2016
Completed Phase 1
~80

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Myositis, such as corticosteroids, immunosuppressants (e.g., methotrexate, azathioprine), and newer agents like PF-06823859, primarily work by modulating the immune system and reducing inflammation. Corticosteroids decrease inflammation by suppressing the immune response, while immunosuppressants inhibit the activity of immune cells that attack muscle tissue. PF-06823859, an investigational drug, aims to further modulate immune pathways to reduce muscle inflammation and improve muscle function. These treatments are crucial for Myositis patients as they help alleviate muscle weakness, improve mobility, and prevent long-term damage caused by chronic inflammation.
P2X7 Receptor Antagonist Reduces Fibrosis and Inflammation in a Mouse Model of Alpha-Sarcoglycan Muscular Dystrophy.Novel molecular targets of muscle wasting in cancer patients.Pharmacological Inhibition of PKCθ Counteracts Muscle Disease in a Mouse Model of Duchenne Muscular Dystrophy.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,670 Previous Clinical Trials
17,826,661 Total Patients Enrolled
1 Trials studying Polymyositis
211 Patients Enrolled for Polymyositis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,867,560 Total Patients Enrolled
1 Trials studying Polymyositis
211 Patients Enrolled for Polymyositis

Media Library

PF-06823859 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05895786 — Phase 3
Polymyositis Research Study Groups: PF-06823859, Placebo
Polymyositis Clinical Trial 2023: PF-06823859 Highlights & Side Effects. Trial Name: NCT05895786 — Phase 3
PF-06823859 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05895786 — Phase 3
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