What side effects are associated with this type of intervention?

Common treatments for myositis, such as corticosteroids, immunosuppressants (e.g., methotrexate), and biologics (e.g., rituximab, IVIG), have various side effects. Corticosteroids can cause weight gain, osteoporosis, and increased infection risk. Methotrexate may lead to gastrointestinal symptoms, liver toxicity, and leukopenia. Rituximab can cause infusion reactions and increase the risk of infections. IVIG is associated with thromboembolic events and infusion-related reactions. These side effects highlight the need for careful monitoring during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for myositis, particularly focusing on immune modulation and anti-inflammatory effects. Methotrexate and azathioprine are commonly used immunosuppressants for DM and PM, often in combination with corticosteroids. Mycophenolate mofetil is another second-line agent for patients who do not respond to initial treatments. Rituximab, targeting CD20-positive B cells, has shown promise in treating refractory cases of DM and PM. These treatments aim to reduce inflammation and modulate the immune response, similar to the investigational drug PF-06823859.

What other types of research exist?

Promising novel alternatives to PF-06823859 for myositis patients include: 1) Masitinib, a selective oral tyrosine kinase inhibitor, which has shown benefits in reducing neuroinflammation and modulating the neuronal microenvironment in ALS. 2) Janus kinase inhibitors (JAKi) like tofacitinib and PF-06651600, which are being tested for various immune-mediated conditions and have shown potential in reducing inflammation. 3) Secukinumab, an IL-17A inhibitor, which has demonstrated efficacy in reducing inflammation in conditions like ankylosing spondylitis and psoriatic arthritis.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 and 52 weeks in the us only

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%

Road traffic accident

20%

Abdominal pain lower

20%

Vaccination site pain

20%

Thermal burn

20%

Intervertebral disc protrusion

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: PF-06823859 300 mg

Placebo

Cohort 2: PF-06823859 900 mg

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

0 / 3Eligibility criteria met

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.

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