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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

Study Summary

This trial studies how well the drug PF-06823859 works for people with DM and PM, who take corticosteroids and/or immunosuppressants. Participants will receive the drug or placebo and have 16 visits over 13 months.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Moderate change in Total Improvement Score (TIS)

Secondary outcome measures

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%

Intervertebral disc protrusion

20%

Vaccination site pain

20%

Thermal burn

20%

Abdominal pain lower

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: PF-06823859 300 mg

Cohort 2: PF-06823859 900 mg

Placebo

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

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,732 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,091,950 Total Patients Enrolled

Media Library

PF-06823859 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05895786 — Phase 3

Myositis Research Study Groups: PF-06823859, Placebo

Myositis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant enrollment rate of this trial?

"To commence the trial, 270 participants who fit the predetermined eligibility criteria need to sign up. Omega Research Orlando and Washington University Pulmonary Function Laboratory are two of several viable locations for clinical participation."

Answered by AI

Are participants still being accepted for this research endeavor?

"As per the information kept on clinicaltrials.gov, participants are being sought for this research effort which was first posted in May 20th of last year and recently edited at the end of that month."

Answered by AI

What has been revealed about PF-06823859's safety profile?

"Our analysis at Power has given PF-06823859 a 3 out of 3 for safety, since this phase 3 trial provides evidence that the drug is efficacious and its safety has been tested several times."

Answered by AI

Who else is applying?

What site did they apply to?

West Broward Rheumatology Associates

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

Why did patients apply to this trial?

I’ve been on Azathioprine for approximately 5 years. My oxygen level had gotten to 14% and is now 41%. Pulse ox ranges 97-99. I have seen and ILD pulmonologist (my pulmonologist referred me). My son has increased substantially. I CANNOT perform everyday household duties.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

2023. "A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05895786.

All > Polymyositis > Dermatomyositis