A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
Start Date
1/22/2025
Completion Date
11/25/2027
Summary
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 work. This study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up. The study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months. There will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Dazukibart
Conditions
Locations
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona 85306
United States
Arthritis & Rheumatology Research Institute, PLLC
Allen, Texas 75013
United States
Nerve & Muscle Center of Texas
Houston, Texas 77030
United States
Rheumatology & Pulmonary Clinic
Beckley, West Virginia 25801
United States
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province T4000AXL
Argentina
Medical Center Artmed
Plovdiv, 4000
Bulgaria
Anhui Provincial Hospital
Hefei, Anhui 230071
China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330036
China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality 200001
China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality 200127
China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650032
China
Peking Union Medical College Hospital
Beijing, 100730
China
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Hungary
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
Ernākulam, Kerala 682040
India
Sheba Medical Center
Ramat Gan, Central District 5262100
Israel
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo 113-8519
Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo 113-8603
Japan
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Mexico City 06100
Mexico
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Masovian Voivodeship 02-637
Poland
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie Voivodeship 15-707
Poland
Chi Mei Medical Center
Tainan, 71004
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Hacettepe Universite Hastaneleri
Altindağ, Ankara 06230
Turkey (Türkiye)