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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.

Överblick

Status
Aktiv men inte rekryterande
Fas
FAS1
Sponsor
UCB Biopharma SRL
Inskrivningsmål
19
Starta
16 Nov 2020
Beräknad slutförande
13 Dec 2027
Progressive Supranuclear Palsy

Vad handlar denna studie om?

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.

Viktiga punkter

  • 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.
  • Deltagande innebär regelbundna klinikbesök och hälsokontroller.
  • You will receive doses of the study medicine, UCB0107.
  • Your contribution helps advance understanding of PSP treatment.

Vem kan vara berättigad?

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.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  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.
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

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.

Potentiella risker och fördelar

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.

Platser (11)

  • Psp002 40122
    Verifierat postnummer
    Edegem, Belgien
  • Psp002 40002
    Verifierat postnummer
    Leuven, Belgien
  • Psp002 40277
    Verifierat postnummer
    Bochum, Tyskland
  • Psp002 40276
    Verifierat postnummer
    Düsseldorf, Tyskland
  • Psp002 40278
    Verifierat postnummer
    Essen, Tyskland
  • Psp002 40024
    Verifierat postnummer
    Hannover, Tyskland
  • Psp002 40267
    Verifierat postnummer
    Barcelona, Spanien
  • Psp002 40100
    Verifierat postnummer
    Madrid, Spanien
  • Psp002 40268
    Verifierat postnummer
    Pamplona, Spain
  • Psp002 40175
    Verifierat postnummer
    London, Storbritannien
  • Psp002 40165
    Verifierat postnummer
    Southampton, Storbritannien

Vanliga frågor

Vad är syftet med denna studie?

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

Vem kan delta i denna studie?

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.

Kan jag sluta delta om jag ändrar mig?

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

Hur du får reda på mer

Officiell rättegångsprotokoll

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Diskussion

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