A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
A legfontosabb adatok
- Ki végzi
- Pfizer
- Hol
- Tainan és Taipei (Tajvan)Mind a 2 helyszín megnézéseMég 14 másik országban, 31 helyszínen
- Azonosító
- Állapot
- Toboroz
- Fázis
- 3. fázis
- Résztvevők
- 211 fő, tervezett
- Kezdés
- 2025. jan. 22.
- Várható befejezés
- 2031. júl. 29.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Dazukibart
- A regiszteradat frissítve
- 2026. augusztus 25.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with dermatomyositis or polymyositis who took part in an earlier dazukibart study. Some will get dazukibart, others will only have safety check-up visits.
- Életkor
- 18 years and older
- Nem
- All sexes
- A betegség stádiuma
- Active idiopathic inflammatory myopathy (dermatomyositis or polymyositis), as described in the summary.
- Korábbi kezelés
- People must have completed an earlier qualifying dazukibart study through Week 52.
A részvétel fő kizáró okai
- Medical or mental health problems, or lab results, that make taking part riskier, including suicidal thoughts or behaviour in the past year or now
- Another study drug or vaccine other than dazukibart within 30 days or 5 half-lives before the start, whichever is longer
- Current use of medicines not allowed in the study
- Active infection of any kind (bacterial, viral, fungal or other)
- An ongoing side effect or safety problem from the earlier study that has not gone away
A regiszter feltételei, szó szerint
Mind a 7 feltétel megnézéseKevesebb
Ki vehet részt
- Participants that completed a qualifying study through Week 52
Ki nem vehet részt
- 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
- 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
- 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
Helyszínek itt: Tajvan
Még 14 másik országban, 31 helyszínen
- Chi Mei Medical CenterTainan, TajvanRésztvevőt keres
- National Taiwan University HospitalTaipei, TajvanRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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]).
A teljes eredeti leírásKevesebb
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.
A vizsgálat csoportja
- DazukibartA vizsgált kezelés
Participants will receive dazukibart via intravenous infusion every 4 weeks.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
- Hivatalos cím
- 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)
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2026. augusztus 25.