BridgeMD
An open-label extension study with dazukibart for participants with idiopathic inflammatory myopathies (including DM or PM) who have completed the treatment period of a qualifying parent study.
EU CTIS ID: 2024-514648-10-00
What this study is testing
To evaluate the long-term safety of dazukibart in participants with DM or PM
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants who have completed the treatment period of a qualifying study and did not discontinue study treatment early will be eligible to receive study drug (OL Treatment Groups). From C0251006 study, participants must have completed the 52-week treatment period of the study to receive study drug in this study.
You likely can't join if
- 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 or, in the investigator’s judgment, make the participant inappropriate for the study.
- 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 (including but not limited to tuberculosis (TB) and atypical mycobacterial disease).
- Participants with an ongoing adverse event in a qualifying study which, in the opinion of the investigator or sponsor, is an ongoing safety concern and makes the participant inappropriate for the study, OR the participant has met safety monitoring criteria in a qualifying study that have not resolved.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Mexico
- India
- Korea, Republic of
- Japan
- Taiwan
- Israel
- China
- United Kingdom
- Turkey
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Mexico; India; Korea, Republic of; Japan; Taiwan and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.