ClinicalTrials.gov record NCT06698796

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age18 years old and older
SexAll
LocationArgentina, Bulgaria, China, Hungary, India, Israel, Japan, Mexico, Poland, Taiwan, Turkey, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label extension follows people who completed a prior dazukibart study for dermatomyositis or polymyositis. Some participants will receive IV dazukibart infusions about once every 4 weeks for up to 48 weeks plus safety follow-up; others will enroll only for safety follow-up without receiving the drug. The study collects safety data, lung and heart monitoring, muscle and skin assessments, and patient-reported outcomes over about 12–16 months.

What it is studying. The study is collecting long-term safety and tolerability data for dazukibart and measuring its effects on muscle strength, skin disease in dermatomyositis, lung function, laboratory results, heart monitoring, and patient-reported symptoms and function.

What the researchers hope to learn. To gather long-term data on the safety, tolerability, and clinical effects of dazukibart in people with idiopathic inflammatory myopathies (dermatomyositis or polymyositis), including adverse events, laboratory and vital-sign changes, lung function, muscle and skin assessments, patient-reported outcomes, medication use, and immunogenicity.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Dazukibart

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Some participants will receive dazukibart as an intravenous (IV) infusion (~1 hour) every 4 weeks from Day 1 to Week 48, then have about 4 months of safety follow-up; those on drug will have about 18 site visits over ~16 months. Other participants will not receive the study medicine and will attend up to 4 safety follow-up visits about every 4 weeks. All participants will have safety monitoring such as blood tests, vital signs, ECGs, lung function tests (FVC/DLCO), and questionnaires including scales for symptoms and suicide-risk; adverse events will be recorded.

How the study is structured. Open-label extension of earlier dazukibart trials. Participants who completed a qualifying study may continue in this follow-up study. Many participants will receive IV infusions of dazukibart every 4 weeks for up to 48 weeks and then a safety follow-up period; a group of participants will instead take part only in safety follow-up visits and will not receive the drug. The study is not blinded.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Argentina, Bulgaria, China, Hungary, India, Israel, Japan, Mexico, Poland, Taiwan, Turkey, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

This trial is also listed on this site under polymyositis.

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 22, 2025
Primary completion
Jul 29, 2031 (estimated)
Study completion
Jul 29, 2031 (estimated)
Target enrollment
211 participants (estimated)
Last updated on registry
Aug 25, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Pfizer

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (26)

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - GlendaleRecruiting

    Glendale, Arizona, 85306 · United States

  • Arthritis & Rheumatology Research Institute, PLLCNot Yet Recruiting

    Frisco, Texas, 75035 · United States

  • Nerve & Muscle Center of TexasRecruiting

    Houston, Texas, 77030 · United States

  • Rheumatology & Pulmonary ClinicActive Not Recruiting

    Beckley, West Virginia, 25801 · United States

  • IR Medical Center SA - Instituto de ReumatologiaRecruiting

    Mendoza, Mendoza Province, T5500 · Argentina

  • Centro de Investigaciones Médicas TucumanRecruiting

    SAN M. de Tucuman, Tucumán Province, T4000AXL · Argentina

  • Medical Center ArtmedRecruiting

    Plovdiv, 4000 · Bulgaria

  • Anhui Provincial HospitalRecruiting

    Hefei, Anhui, 230071 · China

  • The Second Affiliated Hospital of Nanchang UniversityRecruiting

    Nanchang, Jiangxi, 330006 · China

  • The Second Affiliated Hospital of Nanchang UniversityRecruiting

    Nanchang, Jiangxi, 330036 · China

Terms used on this page · explanations by MedicalUpdates.ai

safety follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
investigational product
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
prohibited concomitant
A medicine that participants may not use during the study, usually because it could interfere with the study treatment or its measurement.
adverse event
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
sponsor
The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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