Actively Recruiting
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
Led by Pfizer · Updated on 2026-05-11
211
Participants Needed
7
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants that completed a qualifying study through Week 52
You will not qualify if you...
- 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 other than dazukibart in a qualifying study within 30 days or 5 half-lives preceding baseline
- Current use of any prohibited concomitant medication(s)
- Active bacterial, viral, fungal, mycobacterial or other infections
- Ongoing adverse event in a qualifying study or unresolved safety monitoring criteria
- Investigator site staff or sponsor employees involved in the study and their family members
AI-Screening
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Trial Site Locations
Total: 7 locations
1
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, United States, 85306
Actively Recruiting
2
Nerve & Muscle Center of Texas
Houston, Texas, United States, 77030
Not Yet Recruiting
3
Medical Center Artmed
Plovdiv, Bulgaria, 4000
Actively Recruiting
4
Anhui Provincial Hospital
Hefei, Anhui, China, 230071
Actively Recruiting
5
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
6
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
Ernākulam, Kerala, India, 682040
Actively Recruiting
7
National Taiwan University Hospital
Taipei, Taiwan, 10002
Not Yet Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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