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NCT06698796PHASE3Recruiting

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

Pfizer

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

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.

Interventions

DRUG

Dazukibart

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Conditions

DermatomyositisPolymyositis

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)