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)

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

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)

Sponsor

Novartis HQ IQVIA AG, Branch Basel

(BASEC)