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A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
NCT06698796 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Dazukibart
Study Locations (20)
Other
- Medical Center Artmed — Plovdiv
- Peking Union Medical College Hospital — Beijing
- Debreceni Egyetem Klinikai Kozpont — Debrecen
- National Taiwan University Hospital — Taipei
Texas
- Arthritis & Rheumatology Research Institute, PLLC — Allen
- Nerve & Muscle Center of Texas — Houston
Tokyo
- Institute of Science Tokyo Hospital — Bunkyo-ku
- Nippon Medical School Hospital — Bunkyo-ku
Arizona
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale
West Virginia
- Rheumatology & Pulmonary Clinic — Beckley
Tucumán Province
- Centro de Investigaciones Médicas Tucuman — SAN M. de Tucuman
Anhui
- Anhui Provincial Hospital — Hefei
Jiangxi
- The Second Affiliated Hospital of Nanchang University — Nanchang
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2025-01-22 |
| Est. Completion | 2027-11-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06698796
The ClinicalTrials.gov registry entry for NCT06698796 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Dermatomyositis appearing as the primary indexed condition, and to 1 intervention — of which Dazukibart is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06698796 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Texas, Tokyo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06698796 about?
NCT06698796 is a clinical study titled "A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies". 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 m...
What is the current status of trial NCT06698796?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2025-01-22. Estimated completion is 2027-11-25.
What conditions does trial NCT06698796 study?
This clinical trial studies the following conditions: Dermatomyositis, Polymyositis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06698796?
The interventions under investigation include: Dazukibart (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06698796?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06698796 being conducted?
This trial has 20 study locations across Arizona, Texas, West Virginia, Tucumán Province, Anhui. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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