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

Last updated: April 10, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Lupus

Collagen Vascular Diseases

Myositis

Treatment

Dazukibart

Clinical Study ID

NCT06698796
C0251010
2024-514648-10-00
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Participants that completed a qualifying study through Week 52.

Exclusion

Exclusion Criteria:

  • Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation.

  • Previous administration with an investigational product (drug or vaccine) other thandazukibart in a qualifying study within 30 days (or as determined by the localrequirement) 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 safetymonitoring criteria in a qualifying study that have not resolved.

  • Investigator site staff or sponsor employees directly involved in the conduct of thestudy, site staff otherwise supervised by the investigator, and their respectivefamily members.

Study Design

Total Participants: 211
Treatment Group(s): 1
Primary Treatment: Dazukibart
Phase: 3
Study Start date:
January 22, 2025
Estimated Completion Date:
November 25, 2027

Connect with a study center

  • Medical Center Artmed

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Beijing Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Active - Recruiting

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