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A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies

RecruitingPhase 3Ages 18 Years - anyAllPfizer
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \[DM\] or polymyositis \[PM\]). Idiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM. DM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash. These disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Participants that completed a qualifying study through Week 52. Exclusion Criteria: * Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation. * Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer). * Current use of any prohibited concomitant medication(s). * Active bacterial, viral, fungal, mycobacterial or other infections. * Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved. * Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
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What it tests

  • Dazukibart
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Where

26 sites
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, United States
Arthritis & Rheumatology Research Institute, PLLC
Frisco, United States
Nerve & Muscle Center of Texas
Houston, United States
Rheumatology & Pulmonary Clinic
Beckley, United States
IR Medical Center SA - Instituto de Reumatologia
Mendoza, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Argentina
Medical Center Artmed
Plovdiv, Bulgaria
Anhui Provincial Hospital
Hefei, China

…and 18 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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