Understanding how dazukibart works in patients with inflammatory muscle diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the effects of the medication dazukibart in individuals diagnosed with idiopathic inflammatory myopathies, specifically dermatomyositis and polymyositis. Participants must have previously completed a qualifying study involving dazukibart and will be monitored for their response to the treatment. The study focuses on understanding the medication's mechanism and its impact on muscle inflammation and function. By assessing muscle strength and overall health, the study seeks to provide insights into improving treatment for these debilitating conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
  Glendale, Arizona, United States Recruiting
• Nerve & Muscle Center of Texas
  Houston, Texas, United States Recruiting
• IR Medical Center SA - Instituto de Reumatologia
  Mendoza, Mendoza Province, Argentina Recruiting
• Centro de Investigaciones Médicas Tucuman
  SAN M. de Tucuman, Tucumán Province, Argentina Recruiting
• Medical Center Artmed
  Plovdiv, Bulgaria Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.