Understanding how dazukibart works in patients with inflammatory muscle diseases
A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)
This study is testing how well the medication dazukibart works for people with inflammatory muscle diseases like dermatomyositis and polymyositis to see if it helps reduce muscle inflammation and improve strength.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 211 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 7 sites (Glendale, Arizona and 6 other locations) |
| Trial ID | NCT06698796 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in a study involving dazukibart and have completed the required follow-up.
Not a fit: Patients with active infections, recent suicidal ideation, or those currently on prohibited medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from idiopathic inflammatory myopathies.
How similar studies have performed: While there have been studies on similar medications, the specific approach of using dazukibart in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Glendale, Arizona and 6 other locations
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale, Arizona, United States (Recruiting)
- Nerve & Muscle Center of Texas — Houston, Texas, United States (Not_yet_recruiting)
- Medical Center Artmed — Plovdiv, Bulgaria (Recruiting)
- Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
- First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
- CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited) — Ernākulam, Kerala, India (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Not_yet_recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.