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NCT05895786 · ClinicalTrials.gov registry record · Phase 3
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
A Phase 3 study of Myositis, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 318
- Enrollment target
- 20
- Study locations
NCT05895786 is a Phase 3 study of Myositis that is actively recruiting participants, run by Pfizer. The registered enrollment target is 318 participants, above the 222-participant average among 8 other Myositis trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT05895786, a Phase 3 study of Myositis, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 318 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: * Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater * Have active DM or active PM. * Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. * Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (dazukibart) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about 1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both dazukibart and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if dazukibart is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PF-06823859
Study Locations (20)
Florida
- Mayo Clinic in Florida - Jacksonville
- Lal Bhagchandani, M.D - Margate
- University of Miami - Miami
- University of Miami Dermatology Clinical Trials Unit - Miami
- University of Miami - Miami
- Unviversity of Miami - Miami
- Omega Research Orlando - Orlando
- IRIS Research and Development, LLC - Plantation
- West Broward Pulmonary Consultants - Plantation
California
- 200 UCLA Medical Plaza - Los Angeles
- UCLA Clinical & Translational Research Center (CTRC) - Los Angeles
- UCLA - Los Angeles
- Center for Clinical Research - Chapman Pavilion - Orange
- UCI Douglas Hospital - Orange
- UCI Health Center for Innovative Health Therapies - Orange
- University of California - Irvine - Orange
Arizona
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale - Glendale
- Arizona Arthritis & Rheumatology Associates, P.C. - Glendale
- Mayo Clinic Hospital - Phoenix
- Mayo Clinic in Arizona - Scottsdale - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2023-05-20 |
| Est. Completion | 2027-07-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05895786
The ClinicalTrials.gov registry entry for NCT05895786 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 318 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 222-participant average among 8 other Myositis trials with a reported enrollment target (43% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myositis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05895786 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05895786 about?
NCT05895786 is a clinical study titled "A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]". The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. ...
What is the current status of trial NCT05895786?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 318 participants. The study started on 2023-05-20. Estimated completion is 2027-07-28.
What conditions does trial NCT05895786 study?
This clinical trial studies the following conditions: Myositis.
What interventions are being tested in trial NCT05895786?
The interventions under investigation include: Placebo (DRUG), PF-06823859 (DRUG).
Who is sponsoring clinical trial NCT05895786?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05895786 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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