Recruiting
Phase 3

Dazukibart

Sponsor:

Pfizer

Code:

NCT06698796

Conditions

Dermatomyositis

Polymyositis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dazukibart

Study Details

Brief 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

Dermatomyositis

Polymyositis

Study ID

NCT06698796

Start date

Jan 22, 2025

Status verified date

Aug, 2026

Completion date

Jul 29, 2031

Anticipated

Primary completion date

Jul 29, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants that completed a qualifying study through Week 52.

Exclusion Criteria:

  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation.
  • Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) 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 safety monitoring criteria in a qualifying study that have not resolved.
  • Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Study Design

Enrollment

211 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dazukibart

Participants will receive dazukibart via intravenous infusion every 4 weeks.

Interventions

Dazukibart

anti-interferon beta therapy

Primary outcome measure

  • Treatment-Emergent Adverse Events (AEs), Serious AEs, AEs of Special Interest, and AEs leading to treatment discontinuation [ Time Frame: 52 weeks ]
  • Number of participants with clinically significant laboratory abnormalities [ Time Frame: 52 weeks ]
  • Number of participants with clinically significant abnormalities in vital signs [ Time Frame: 52 weeks ]
  • Number of participants with clinically significant electrocardiogram (ECG) abnormalities [ Time Frame: 52 weeks ]
  • Change from baseline in Forced Vital Capacity (FVC)/Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) [ Time Frame: 52 weeks ]
  • Absolute values and change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Locations

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Recruiting

Glendale, Arizona, United States, 85306

Nerve & Muscle Center of Texas

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Pfizer

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-25.