A randomized, double-blind, placebo-controlled parallel-group Phase II study of VHB937 in amyotrophic lateral sclerosis (ALS) over 40 weeks, followed by an open extension (ASTRALS)
Zusammenfassung der Studie
The purpose of this study is to learn more about the effects of VHB937 compared to placebo in people with amyotrophic lateral sclerosis (ALS) who are currently not receiving a therapy approved for the disease or are on a stable dose of an approved ALS therapy. VHB937 is an antibody that works by activating a protein that stimulates important brain cells called microglia to protect nerve cells. This could prevent damage to nerve cells and help slow the progression of amyotrophic lateral sclerosis (ALS). A placebo looks like the investigational drug but contains no active ingredient. By using a placebo, researchers can better understand the effect of an investigational drug. This study consists of 2 parts. The investigators will first begin with Part A followed by Part B. Part A: It is planned that approximately 225 participants will be enrolled in Part A. Participants will be randomly assigned to 1 of 2 groups. Group 1 will have twice as many participants assigned as Group 2. Group 1: Participants will receive a VHB937 infusion directly into a vein once a month for approximately 10 months. Group 2: Participants will receive a placebo infusion directly into a vein once a month for approximately 10 months. Part B: After completing Part A, the physician will assess the interest of participants in receiving a VHB937 infusion directly into a vein once a month. In this open extension, all participants will receive VHB937 until the last participant ends the VHB937 treatment. The investigators will monitor the amyotrophic lateral sclerosis (ALS) and the overall health status of the participants throughout the study.
(BASEC)
Untersuchte Intervention
Participants can be 18 years or older. They can be male or female and of any ethnic background. Women of childbearing potential must agree to use highly effective contraceptive methods.
Population of the clinical study: Adults with a diagnosis of ALS.
(BASEC)
Untersuchte Krankheit(en)
Amyotrophic lateral sclerosis (ALS) is a fatal disease of the nervous system that affects the cells in the brain and spinal cord that control muscle movement. This can lead to symptoms such as muscle twitching, weakness in an arm or leg, and difficulty swallowing. The disease ultimately leads to paralysis and respiratory failure. The average survival time after the onset of symptoms in amyotrophic lateral sclerosis is 2 to 4 years.
(BASEC)
• amyotrophic lateral sclerosis (ALS) confirmed by the investigators through various examinations • Mild symptoms of amyotrophic lateral sclerosis (ALS) assessed with the ALSFRS-R questionnaire • Onset of symptoms of amyotrophic lateral sclerosis (muscle weakness) within 24 months prior to participation in this study • have not received treatment for amyotrophic lateral sclerosis (ALS) and are not on a stable dose of an approved medication for amyotrophic lateral sclerosis • must be able to exhale a lung volume that is at least 60% of the expected amount for the participant's sex, height, and age (BASEC)
Ausschlusskriterien
• recent use of an experimental ALS medication • an allergic reaction to any of the treatments used in the study • Women of childbearing potential must agree to use a highly effective contraceptive method for 24 weeks after discontinuation of the investigational product. • Administration of live vaccines or live attenuated vaccines in the last 3 months prior to the study • Individuals requiring ventilatory support due to ALS • recent heart attack, unstable angina, clinically significant arrhythmia • clinically significant anemia or low white blood cell count • severe liver disease or recent liver damage • severe kidney disease • unstable psychiatric condition, cognitive impairment, or dementia • active cancer • infection with human immunodeficiency virus (HIV), active hepatitis B or C • uncontrolled diabetes (BASEC)
Studienstandort
Basel, St Gallen
(BASEC)
Sponsor
Novartis HQ IQVIA AG, Branch Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Vanessa Haller
+41714943581
vanessa.haller@clutterh-och.chKantonsspital St. Gallen
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
30.01.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
A phase 2, randomized, double-blind, placebo-controlled parallel group study of VHB937 in Amyotrophic Lateral Sclerosis (ALS) over 40 weeks followed by an Open-label Extension (ASTRALS) (BASEC)
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ergebnisse der Studie
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