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

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Pfizer
Study ID
NCT06698796
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Dermatomyositis
  • Polymyositis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dazukibart — DRUG
    anti-interferon beta therapy

Study Details

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.

Key Dates

Start date
Jan 22, 2025
Status verified
May 2026
Primary completion
Nov 25, 2027
Completion
Nov 25, 2027

Study Design

Enrollment
211 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dazukibart
    Participants will receive dazukibart via intravenous infusion every 4 weeks.

Primary Outcome Measure

Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation [ Time Frame: 52 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - GlendaleGlendaleArizona85306-
Arthritis & Rheumatology Research Institute, PLLCAllenTexas75013-
Nerve & Muscle Center of TexasHoustonTexas77030-
Rheumatology & Pulmonary ClinicBeckleyWest Virginia25801-

Find similar trials in Glendale, AZ

By research site
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale· Glendale, AZArthritis & Rheumatology Research Institute, PLLC· Allen, TXNerve & Muscle Center of Texas· Houston, TXRheumatology & Pulmonary Clinic· Beckley, WV

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