Patientenforschung
Anmelden
Alle Studien
Aktiv, aber nicht rekrutierendPHASE1INTERVENTIONELL

A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy

This research study is focused on understanding the long-term safety of a new drug called UCB0107 (also known as bepranemab) for individuals living with Progressive Supranuclear Palsy (PSP). PSP is a rare brain condition that affects movement, balance, speech, and swallowing. This particular study is designed for people who have already taken part in a related PSP study (PSP003). By following these participants for a longer time, doctors hope to gather more information about how safe UCB0107 is when used over an extended period. The aim is to make sure any potential new treatments are as safe as possible for patients.

Auf einen Blick

Status
Aktiv, aber nicht rekrutierend
Phase
PHASE1
Sponsor
UCB Biopharma SRL
Einschreibeziel
19
Starten
16. Nov. 2020
Geschätzte Fertigstellung
13 Dec 2027
Progressive Supranukleäre Blickparese

Worum geht es in dieser Studie?

This study is about a condition called Progressive Supranuclear Palsy, or PSP. PSP is a serious condition that can affect your movement, balance, speech, and even your ability to swallow. Researchers are trying to find new ways to help people with PSP, and one of these ways involves looking at a new medicine called UCB0107. This particular study is focused on checking if UCB0107 is safe to use over a longer period of time.

You might be interested in this study if you've already taken part in an earlier study for PSP called PSP003. This new study is like a continuation, allowing the research team to keep a close eye on your health and how the medicine affects you over the long term. This is very important because knowing if a medicine is safe over many months or even years helps doctors decide if it could be a good treatment option in the future.

By taking part, you'd be helping scientists learn more about PSP and potentially find better ways to manage the condition. Every step in research, especially looking at long-term safety, brings us closer to understanding and treating complex conditions like PSP.

Wichtige Erkenntnisse

  • This study evaluates the long-term safety of UCB0107 for PSP.
  • It's for people who have already joined and completed a previous study called PSP003.
  • Participation involves regular clinic visits and health checks.
  • You will receive doses of the study medicine, UCB0107.
  • Your contribution helps advance understanding of PSP treatment.

Wer könnte berechtigt sein?

You might be able to join this study if you have already been diagnosed with Progressive Supranuclear Palsy (PSP), specifically a type called Richardson's Syndrome. A key requirement is that you must have previously participated in a specific earlier study, called PSP003 (NCT04185415), and completed the treatment part of that study.

Anyone, male or female, aged 40 or over can be considered. If you are a woman who could become pregnant, or a man, you would need to agree to use effective birth control methods during the study and for some months after the last dose of the study medicine to prevent pregnancy.

You cannot join if you had to stop the previous PSP003 study for certain safety reasons, or if you had serious thoughts of harming yourself during the PSP003 study. However, even if you did have suicidal thoughts, the study doctors might still consider you if a mental health expert believes it's safe for you to participate.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. I have been diagnosed with Progressive Supranuclear Palsy (PSP), specifically Richardson's Syndrome.
  2. I have already completed the treatment part of a previous study called PSP003 (NCT04185415).
  3. I am 40 years old or older.
  4. I am able and willing to follow the study's contraception guidelines, if applicable.
  5. I did not have to leave the PSP003 study due to a mandatory safety reason.
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

If you decide to take part, the main purpose is to monitor your health and how your body responds to the study medicine, UCB0107, over a longer period. Since you've already been part of the previous PSP003 study, you'll be continuing your involvement, and the research team will explain exactly what this new, longer-term study will involve for you.

You will have regular visits to the clinic where the study team will carry out various assessments. These will likely include physical examinations, blood tests, and possibly other tests to check your overall health and how the medicine is affecting you. You will also continue to receive doses of UCB0107 as planned by the study doctors.

The research team will provide you with a detailed plan of visits and assessments. The total duration of your participation will depend on the study design and your individual response, and they will explain this clearly before you make any decision.

Potenzielle Risiken und Vorteile

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is that it allows for continued monitoring of your health and the effects of UCB0107, which could offer insights into managing your PSP. Your participation also directly contributes to scientific knowledge about PSP, potentially helping many others in the future. However, there may be side effects from the study medicine, UCB0107, and you might experience discomfort from tests or clinic visits. All possible side effects will be explained to you. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Standorte (11)

  • Psp002 40122
    Verifizierte Postleitzahl
    Edegem, Belgien
  • Psp002 40002
    Verifizierte Postleitzahl
    Leuven, Belgien
  • Psp002 40277
    Verifizierte Postleitzahl
    Bochum, Germany
  • Psp002 40276
    Verifizierte Postleitzahl
    Düsseldorf, Germany
  • Psp002 40278
    Verifizierte Postleitzahl
    Essen, Germany
  • Psp002 40024
    Verifizierte Postleitzahl
    Hannover, Deutschland
  • Psp002 40267
    Verifizierte Postleitzahl
    Barcelona, Spanien
  • Psp002 40100
    Verifizierte Postleitzahl
    Madrid, Spanien
  • Psp002 40268
    Verifizierte Postleitzahl
    Pamplona, Spain
  • Psp002 40175
    Verifizierte Postleitzahl
    London, Vereinigtes Königreich
  • Psp002 40165
    Verifizierte Postleitzahl
    Southampton, Vereinigtes Königreich

Häufige Fragen

Was ist der Zweck dieser Studie?

The study aims to check the long-term safety of the medicine UCB0107 for people with Progressive Supranuclear Palsy (PSP).

Wer kann an dieser Studie teilnehmen?

This study is for people aged 40 and over who have PSP and have already completed an earlier study called PSP003.

What is UCB0107?

UCB0107 (also called bepranemab) is the name of the medicine being studied for PSP.

Will I receive the study medicine?

Yes, if you join this study, you will continue to receive doses of UCB0107.

Kann ich die Teilnahme beenden, wenn ich meine Meinung ändere?

Yes, you can leave the study at any time, for any reason, and your medical care will not be affected.

Wie Sie mehr erfahren können

Offizielles Gerichtsprotokoll

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

Diskussion

Community-Diskussion

Bereitgestellt von unserem Forum bei community.patient.info. Bitte seien Sie respektvoll — dies ist kein medizinischer Rat.