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

Last updated: April 6, 2026
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Myositis

Idiopathic Inflammatory Myopathies

Connective Tissue Diseases

Treatment

Dazukibart

Clinical Study ID

NCT06698796
C0251010
2024-514648-10-00
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants that completed a qualifying study through Week 52.

Exclusion

Exclusion Criteria:

  • Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation.

  • Previous administration with an investigational product (drug or vaccine) other thandazukibart in a qualifying study within 30 days (or as determined by the localrequirement) 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 safetymonitoring criteria in a qualifying study that have not resolved.

  • Investigator site staff or sponsor employees directly involved in the conduct of thestudy, site staff otherwise supervised by the investigator, and their respectivefamily members.

Study Design

Total Participants: 211
Treatment Group(s): 1
Primary Treatment: Dazukibart
Phase: 3
Study Start date:
January 22, 2025
Estimated Completion Date:
November 25, 2027

Connect with a study center

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province T4000AXL
    Argentina

    Active - Recruiting

  • Medical Center Artmed

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • Medical Center Artmed

    Plovdiv 728193, 4000
    Bulgaria

    Site Not Available

  • Anhui Provincial Hospital

    Hefei, Anhui 230071
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei 1808722, Anhui 1818058 230071
    China

    Site Not Available

  • Beijing Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Site Not Available

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality 200001
    China

    Active - Recruiting

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200127
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming 1804651, Yunnan 1785694 650032
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100730
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing 1816670, 100730
    China

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen 721472, 4032
    Hungary

    Site Not Available

  • CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)

    Ernakulam, Kerala 682040
    India

    Site Not Available

  • CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)

    Ernākulam, Kerala 682040
    India

    Active - Recruiting

  • CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)

    Ernākulam 1272018, Kerala 1267254 682040
    India

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, Central District 5262100
    Israel

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo 113-8603
    Japan

    Active - Recruiting

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Mexico City 06100
    Mexico

    Active - Recruiting

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc 3827409, Mexico City 3527646 06100
    Mexico

    Site Not Available

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, Masovian Voivodeship 02-637
    Poland

    Site Not Available

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw 756135, Masovian Voivodeship 858787 02-637
    Poland

    Site Not Available

  • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Bialystok, Podlaskie Voivodeship 15-707
    Poland

    Site Not Available

  • Chi Mei Medical Center

    Tainan, 71004
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Hacettepe Universite Hastaneleri

    Altindağ, Ankara 06230
    Turkey (Türkiye)

    Active - Recruiting

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

    Glendale, Arizona 85306
    United States

    Active - Recruiting

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

    Glendale 5295985, Arizona 5551752 85306
    United States

    Site Not Available

  • Arthritis & Rheumatology Research Institute, PLLC

    Allen, Texas 75013
    United States

    Site Not Available

  • Nerve & Muscle Center of Texas

    Houston, Texas 77030
    United States

    Site Not Available

  • Arthritis & Rheumatology Research Institute, PLLC

    Allen 4670300, Texas 4736286 75013
    United States

    Site Not Available

  • Nerve & Muscle Center of Texas

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Active - Recruiting

  • Rheumatology & Pulmonary Clinic

    Beckley 4798308, West Virginia 4826850 25801
    United States

    Site Not Available

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