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Monoclonal Antibodies

VHB937 for ALS (ASTRALS Trial)

Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* have ALS confirmed by the trial doctors using different tests.
* are 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up db up to week 40; db and ole up to week 100

Summary

This trial aims to test the effectiveness and safety of VHB937 in people with early-stage ALS. Participants will receive either VHB937 or a placebo for 40 weeks in a double-blind manner,

Who is the study for?
This trial is for adults over 18 with early-stage ALS, diagnosed within the last two years and having mild symptoms. Participants must not have started any ALS treatment or be on a stable approved dose. They should also have a certain level of breathing function and agree to use strict contraception if they can have children.
What is being tested?
The study tests VHB937 against a placebo in people with early-stage ALS. It's randomized (participants are put into groups by chance), double-blind (neither doctors nor participants know who gets what), and includes an initial 40-week treatment period followed by an open label phase where everyone knows what they're getting.
What are the potential side effects?
Specific side effects of VHB937 aren't listed here, but clinical trials typically monitor for reactions like nausea, headaches, allergic responses, or other drug-specific concerns that may arise during the testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ALS diagnosis has been confirmed by the trial's doctors.
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I am 18 years old or older.
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My ALS symptoms are mild, with an ALSFRS-R score of 30 or more.
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I can exhale at least 60% of the expected air volume for my age, sex, and height.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~db up to week 40; db and ole up to week 100
This trial's timeline: 3 weeks for screening, Varies for treatment, and db up to week 40; db and ole up to week 100 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The composite of PAV-free survival and change in ALSFRS-R. Analysis method: Combined Assessment of Function and Survival (CAFS)
Secondary study objectives
ALS Functional Rating Scale Revised (ALSFRS-R) total score
Cerebralspinal Spinal Fluid Pharmacokinetics (PK) of VHB937-CMAX
Cerebralspinal Spinal Fluid Pharmacokinetics (PK) of VHB937-CTROUGH
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1Experimental Treatment1 Intervention
I.V. infusions every 4 weeks
Group II: Arm 2Placebo Group1 Intervention
I.V. infusions every 4 weeks

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,919 Previous Clinical Trials
4,254,282 Total Patients Enrolled
~150 spots leftby Jan 2027
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