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

Launched by PFIZER · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a medicine called dazukibart works for people with two muscle disorders known as dermatomyositis (DM) and polymyositis (PM). These conditions cause inflammation in the muscles, leading to weakness, especially in the hips, thighs, upper arms, and neck. Patients may struggle with everyday activities like climbing stairs or lifting things, and those with DM might also experience a skin rash. The goal of the study is to see if dazukibart can help improve muscle strength and overall quality of life for people dealing with these challenges.

To participate, individuals must have previously been part of a related study with dazukibart and completed it successfully. Participants will receive the study medicine through an IV (a tube placed in a vein) once every four weeks for about a year, along with regular check-ups throughout the study. Some volunteers may choose not to receive the medicine but will still attend follow-up visits to monitor their health. This research is currently recruiting participants aged 65 and older, and it’s important for interested individuals to review the eligibility criteria carefully to ensure they qualify for the study.

Gender

ALL

Eligibility criteria

• 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.