A clinical trial to provide continued access to remibrutinib (LOU064) for people who are benefiting from it in a previous remibrutinib trial

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 who took remibrutinib in an earlier Novartis trial and are still benefiting from it. They get continued access to the drug.

Életkor

18 Years and older

Nem

All

A betegség stádiuma

Chronic spontaneous urticaria or another skin or allergy condition studied in an earlier remibrutinib trial.

Korábbi kezelés

Must have completed treatment with remibrutinib in an earlier Novartis trial, as that trial's protocol required. People whose earlier trial was stopped by Novartis for technical or administrative reasons can join. This does not apply if it was stopped for safety or because the drug did not work. People whose disease came back during the treatment-free follow-up of the earlier trial can join right away.

A részvétel fő kizáró okai

• Stopped the study treatment early in the earlier trial
• Using medicines that the study protocol does not allow
• Able to get the marketed remibrutinib through local programs, a prescription or insurance
• The study doctor judges that the drug no longer helps or that the risk outweighs the benefit

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

To evaluate long-term safety as assessed by occurrence of AEs/SAEs