Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06698796 · ClinicalTrials.gov registry record · Phase 3
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
A Phase 3 study of Dermatomyositis and Polymyositis, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
- 20
- Study locations
NCT06698796 is a Phase 3 study of Dermatomyositis and Polymyositis that is actively recruiting participants, run by Pfizer. The registered enrollment target is 211 participants, below the 474-participant average among 19 other Dermatomyositis trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT06698796, a Phase 3 study of Dermatomyositis and Polymyositis, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 474-participant average among 19 other Dermatomyositis trials with a reported enrollment target (55% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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.
NCT06698796 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, Texas, Tokyo.
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.
What interventions are being tested in trial NCT06698796?
The interventions under investigation include: Dazukibart (DRUG).
Who is sponsoring clinical trial NCT06698796?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Dermatomyositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
ACTIVE NOT RECRUITING · Phase 3
-
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
COMPLETED · Phase 3
-
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
RECRUITING · Phase 1
-
Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
RECRUITING
-
Adult and Juvenile Myositis
RECRUITING
-
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.