Study on the Effects of VHB937 in Patients with Amyotrophic Lateral Sclerosis (ALS)

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called VHB937 for people with Amyotrophic Lateral Sclerosis (ALS). ALS is a progressive disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness and loss of physical function. The study aims to understand how well VHB937 works compared to a placebo in improving survival without the need for permanent assisted ventilation and maintaining function in individuals with ALS.

Participants in the study will receive either VHB937 or a placebo through an intravenous infusion, which means the treatment is given directly into a vein. The study will last for 40 weeks, during which participants will be monitored for changes in their condition. After this period, there will be an open-label extension, where all participants may receive VHB937, allowing researchers to gather more information about the treatment’s long-term effects.

The main goal of the study is to compare the effectiveness of VHB937 against a placebo in terms of survival without permanent assisted ventilation and overall function. Researchers will also look at other factors, such as changes in muscle strength, breathing capacity, and quality of life. Safety and any side effects will be closely monitored throughout the study to ensure the well-being of all participants.

1 randomization and initial treatment

Upon joining the study, participants are randomly assigned to receive either the experimental drug VHB937 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

The treatment is administered as a concentrate for solution, given through an intravenous infusion. This involves receiving the medication directly into a vein.

2 double-blind phase

The double-blind phase lasts for 40 weeks. During this time, participants continue to receive either VHB937 or the placebo.

Participants are monitored for changes in their condition, including survival without the need for permanent assisted ventilation and changes in functional ability.

3 open-label extension

After completing the double-blind phase, participants enter an open-label extension phase. In this phase, all participants receive VHB937, regardless of their initial group.

This phase continues until Week 100 or until the study ends, allowing further observation of the drug’s effects over a longer period.

4 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor their health and the effects of the treatment. These include evaluations of functional ability, quality of life, and vital signs.

Safety is closely monitored, with attention to any adverse events or changes in laboratory data.

5 end of study

The study is estimated to conclude by April 2029. At this point, all data collected will be analyzed to determine the efficacy and safety of VHB937 in treating amyotrophic lateral sclerosis (ALS).

Who Can Join the Study?

You must sign a document called an informed consent before joining the study. This means you agree to participate and understand what the study involves.
You need to have a type of condition called Amyotrophic Lateral Sclerosis (ALS), which can be either sporadic (occurring randomly) or familial (running in families). The diagnosis should be made using specific guidelines known as the revised El Escorial criteria.
You must be at least 18 years old.
Your ALS symptoms, like muscle weakness, should have started within the last 24 months.
Your Slow Vital Capacity (SVC), which measures how much air you can exhale slowly, should be at least 60% of what is expected for your age, height, and sex.
Your ALSFRS-R total score, which is a way to measure your physical abilities, should be 30 or higher.
You can be either treated or untreated with standard ALS therapies. If you are treated, you should be on a stable dose of medications like riluzole or edaravone for at least 30 days, or have completed at least one cycle of edaravone given through an IV.
You must be able and willing to travel to the study site.

Who Cannot Join the Study?

Patients who do not have Amyotrophic Lateral Sclerosis (ALS) cannot participate. ALS is a disease that affects the nerve cells in the brain and spinal cord, leading to muscle weakness.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other medical conditions that might interfere with the study or its results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are participating in another clinical trial at the same time cannot participate.
Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.
Patients who have used certain medications recently that might interfere with the study cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have a mental health condition that might interfere with their ability to participate in the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
City Clinic Research Sp. z o.o.	Warsaw	Poland
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Rostock University Medical Center	Rostock	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Region Vaesterbotten	Umea	Sweden
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Hospital Del Mar	Barcelona	Spain
Region Stockholm – SLSO	Stockholm	Sweden
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Linden Sp. z o.o. sp.k.	Cracow	Poland
University Of Skane	Malmo	Sweden
Neuroprotect Sp. z o.o.	Warsaw	Poland
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Turku University Hospital	Turku	Finland
Universita’ Di Pisa	Pisa	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Aalborg University Hospital	Aalborg	Denmark
Centre Hospitalier Universitaire De Nice	Nice	France
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Beaumont Hospital	Dublin	Ireland
Djnxzxcaw Kotpwznbzva gzows	Hanover	Germany
Civhml Hjfvcftkntw En Uhaulzjrvplvs Dc Lpjsbpz	Limoges	France
Hkiflk Hhnkuekc	Herlev	Denmark
Ctqasm Hoiyaaxkklt Rasvzucv Uwdchqigsbwan Dk Tljuo	Tours	France
Agctqxs Obvgtsffsyb Ucwgcojsvtdlr Cuutrltcsaso Dkjem Sbxzwd E Dtvsp Symenfv Dx Tupnpe	Turin	Italy
Umyjgmjsmjazsyvbttwes Mwaknbes Aim	Munster	Germany
Hnrueqqv Ubxxzrzhhqiqt Dfphhgqh	Donostia / San Sebastian	Spain
Ueggkhelpkqymiffslrql Wzirrqaez Ahj	Wuerzburg	Germany
Hldbuxkf Vxbu drdotsbt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	13.03.2025
Denmark	Not recruiting	13.03.2025
Finland	Not recruiting	13.03.2025
France	Not recruiting	13.03.2025
Germany	Not recruiting	13.03.2025
Ireland	Not recruiting	13.03.2025
Italy	Not recruiting	13.03.2025
Poland	Not recruiting	13.03.2025
Spain	Not recruiting	13.03.2025
Sweden	Not recruiting	13.03.2025
The Netherlands	Not recruiting	13.03.2025

Trial locations

Investigated drugs:

VHB937

VHB937 is a medication being studied for its potential to help people with Amyotrophic Lateral Sclerosis (ALS). ALS is a condition that affects the nerve cells in the brain and spinal cord, leading to loss of muscle control. The trial is investigating whether VHB937 can improve survival without the need for permanent assisted ventilation and maintain physical function in patients.

Investigated diseases:

Amyotrophic lateral sclerosis

Amyotrophic Lateral Sclerosis (ALS) – ALS is a progressive neurological disease that affects nerve cells in the brain and spinal cord. It leads to the gradual degeneration and death of motor neurons, which are responsible for controlling voluntary muscles. As these neurons deteriorate, individuals experience muscle weakness and atrophy, often starting in the limbs. Over time, the weakness spreads to other parts of the body, affecting speech, swallowing, and breathing. The progression of ALS varies among individuals, but it typically leads to increasing disability. The exact cause of ALS is not fully understood, and it is considered a rare disease.

Trial ID:

2024-512536-29-00

Protocol code:

CVHB937B12201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of VHB937 in Patients with Amyotrophic Lateral Sclerosis (ALS)

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