Not recruitingRare disease

Study on the Long-Term Safety of Bepranemab for Adults with Progressive Supranuclear Palsy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Progressive Supranuclear Palsy, a rare brain disorder that affects movement, balance, and eye movements. The study is testing a treatment called Bepranemab, which is given as a solution through an infusion into the vein. The purpose of the study is to evaluate the long-term safety and tolerability of this treatment in adults with this condition.

Participants in the study will receive Bepranemab over an extended period. The study will monitor participants to see if they experience any side effects or changes in their condition. This is an open-label extension study, meaning that all participants will receive the actual treatment rather than a placebo. The study aims to gather information on how well participants tolerate the treatment over time.

The study will continue until 2027, allowing researchers to collect comprehensive data on the long-term effects of Bepranemab in individuals with Progressive Supranuclear Palsy. This information will help determine if the treatment is safe for long-term use and if it can be a viable option for managing this challenging condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must have completed the treatment period in a previous study related to progressive supranuclear palsy (PSP).
The participant must meet specific criteria for PSP and provide informed consent before any study procedures begin.
Step 2
Treatment administration
The participant will receive a medication called bepranemab, which is a solution for infusion.
The medication is administered through an intravenous route, meaning it is given directly into a vein.
Step 3
Monitoring and follow-up
Throughout the study, the participant's health will be monitored to assess the long-term safety and tolerability of the medication.
The primary focus is on identifying any adverse events that may occur from the start of the study until its conclusion.
Step 4
Study duration
The study is expected to continue until March 30, 2027.
Participants will be involved in the study for the entire duration unless specific circumstances require early withdrawal.

Who can join the trial?

6 criteria

The participant must have a condition called Progressive Supranuclear Palsy (PSP), specifically Richardson's Syndrome, as defined by certain medical criteria.
The participant must have completed the treatment period in a previous study called PSP003, regardless of how many infusions they received.
The participant can be either male or female.
If the participant is male, he must agree to use birth control during the treatment period and for at least 6 months after the last dose of the study treatment. He should also not donate sperm during this time.
If the participant is female, she must not be pregnant or breastfeeding. She must either be unable to have children or agree to use birth control during the treatment period and for at least 6 months after the last dose of the study treatment.
The participant, or their legal representative, must be able to give signed informed consent, which means they understand and agree to follow the study's rules and requirements.

Who cannot join the trial?

8 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients with a history of severe allergic reactions to medications.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures or follow-up visits.
Patients with any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital Clinic De Barcelona
Barcelona, Spain
Verified
Hospital Universitario De Navarra
Pamplona, Spain
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

UCB0107 is a medication being studied for its safety and tolerability in people with progressive supranuclear palsy (PSP). This trial aims to understand how well patients can handle long-term use of this medication. PSP is a rare brain disorder that affects movement, balance, and eye movements. UCB0107 is being tested to see if it can help manage the symptoms of this condition over an extended period.

Bepranemab

What is already known about the treatment

UCB0107 – This medication is administered through injections and is currently being studied in clinical trials for its safety and tolerability in treating Progressive Supranuclear Palsy (PSP). It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for UCB0107 is PSP, a rare brain disorder that affects movement, balance, and eye movements. At the molecular level, UCB0107 is designed to target and modify specific proteins involved in the disease process, potentially slowing its progression. It falls under the pharmacological classification of monoclonal antibodies, which are engineered to interact with specific targets in the body.

Investigated diseases

Progressive Supranuclear Palsy – Progressive Supranuclear Palsy is a rare brain disorder that affects movement, balance, and eye movements. It is characterized by the gradual deterioration of specific areas in the brain, leading to difficulties with walking and balance, as well as stiffness and awkward movements. Individuals with this condition often experience problems with eye movements, particularly in looking up and down, which can lead to falls. As the disease progresses, it may also affect speech and swallowing. The exact cause of Progressive Supranuclear Palsy is not well understood, but it involves the accumulation of abnormal protein deposits in the brain. Symptoms typically begin in late middle age and gradually worsen over time.