Dazukibart for Myositis

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Pfizer

Must not be taking: Prohibited medications

Disqualifiers: Suicidal ideation, Infections, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use any prohibited medications during the study. It's best to discuss your current medications with the study team to see if they are allowed.

Eligibility Criteria

This trial is for people who have muscle inflammation diseases called DM or PM and previously participated in a dazukibart study. They must have completed the prior study through Week 52 to join.

Inclusion Criteria

I completed a study up to Week 52.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dazukibart via intravenous infusion every 4 weeks

48 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

4 visits (in-person)

Open-label extension

Participants may opt into continuation of treatment long-term

Participant Groups

The trial tests how dazukibart, given as an IV infusion every 4 weeks for about a year, affects those with DM or PM. Some participants will receive this medication while others will only attend safety follow-up visits without receiving it.

1Treatment groups

Experimental Treatment

Group I: DazukibartExperimental Treatment1 Intervention

Participants will receive dazukibart via intravenous infusion every 4 weeks.