A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies (NCT06698796)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale, Arizona
- Arthritis & Rheumatology Research Institute, PLLC — Frisco, Texas
- Nerve & Muscle Center of Texas — Houston, Texas
- Rheumatology & Pulmonary Clinic — Beckley, West Virginia
- IR Medical Center SA - Instituto de Reumatologia — Mendoza, Mendoza Province
- Centro de Investigaciones Médicas Tucuman — SAN M. de Tucuman, Tucumán Province
- Medical Center Artmed — Plovdiv,
- Anhui Provincial Hospital — Hefei, Anhui
- The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi
- The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi
- Renji Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality
- Renji Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality
- First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan
- Peking Union Medical College Hospital — Beijing,
- Debreceni Egyetem Klinikai Kozpont — Debrecen,
- Medanta - The Medicity — Gurugram, Haryana
- CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited) — Ernākulam, Kerala
- Sheba Medical Center — Ramat Gan, Central District
- Institute of Science Tokyo Hospital — Bunkyo-ku, Tokyo
- Nippon Medical School Hospital — Bunkyo-ku, Tokyo
- Cryptex Investigación Clínica S.A. de C.V. — Cuauhtémoc, Mexico City
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji — Warsaw, Masovian Voivodeship
- Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty — Bialystok, Podlaskie Voivodeship
- Chi Mei Medical Center — Tainan,
- National Taiwan University Hospital — Taipei,
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis — Cleveland, Ohio
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Explore by condition: All Dermatomyositis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.