Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06698796

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants that completed a qualifying study through Week 52
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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