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Taking people in BulgariaPhase 3

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

Key facts

Who runs it
Pfizer
Where
Plovdiv and Sofiya, BulgariaSee the 2 sitesAlso in 14 other countries, 31 sites
Status
Recruiting
Phase
Phase 3
People taking part
211 people, planned
Started
22 Jan 2025
Expected to end
29 Jul 2031
Type of study
Interventional
Treatments tested
  • Dazukibart
Record updated
25 August 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Participants that completed a qualifying study through Week 52

Who cannot take part

  • 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
  • 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
  • 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

Where in Bulgaria

Also in 14 other countries, 31 sites

  • Medical center "Artmed" LTDPlovdiv, BulgariaTaking people
  • Dkc Fokus-5 Lzip OODSofiya, BulgariaTaking people

About the trial

What the trial wants to find out

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]).

Read full original descriptionShow less

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.

The group in the trial

  • DazukibartTreatment being tested

    Participants will receive dazukibart via intravenous infusion every 4 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)
Record updated
25 August 2026