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Monoclonal Antibodies
HEALEY ALS Platform Trial - Regimen A Zilucoplan
Phase 2 & 3
Waitlist Available
Led By Merit Cudkowicz
Research Sponsored by Merit E. Cudkowicz, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 weeks
Summary
This trial will help researchers learn more about how zilucoplan works in people with ALS, what the side effects are, and how well it works.
Eligible Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Amyotrophic Lateral Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease Progression as Assessed by the ALSFRS-R Total Score
Mortality Event Rate
Secondary study objectives
Muscle Strength
Number of Participants That Experienced Death or Death Equivalent
Respiratory Function
Side effects data
From 2022 Phase 2 & 3 trial • 162 Patients • NCT0443649732%
Fall
24%
Muscular weakness
18%
Injection site bruising
18%
Neuromyopathy
15%
Injection site pain
14%
Fatigue
11%
Headache
11%
Constipation
10%
Dizziness
10%
Dysphagia
8%
Nausea
7%
Cough
7%
Diarrhoea
7%
Oedema peripheral
7%
Dysarthria
6%
Rash
6%
Dyspnoea
6%
Pruritus
6%
Contusion
6%
Anxiety
5%
Tension headache
5%
Urinary tract infection
5%
Respiratory Failure
5%
Decreased appetite
4%
Arthralgia
4%
Pain in extremity
4%
Hypertension
3%
Salivary hypersecretion
3%
Injection site reaction
2%
COVID-19
2%
Pulmonary embolism
2%
Pneumonia aspiration
2%
Generalised oedema
2%
Post-traumatic pain
1%
Device malfunction
1%
Traumatic haematoma
1%
Deep vein thrombosis
1%
Oesophageal carcinoma
1%
Increased upper airway secretion
1%
Faecaloma
1%
Pancreatitis
1%
Pneumoperitoneum
1%
COVID-19 pneumonia
1%
Pneumonia
1%
Cardiac arrest
1%
Cardiac failure congestive
1%
Supraventricular tachycardia
1%
Chest pain
1%
Tinnitus
1%
Vomiting
1%
Hepatic enzyme increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zilucoplan
Matching Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZilucoplanExperimental Treatment1 Intervention
Drug: Zilucoplan Administration: Subcutaneous injection
Dosage: 0.3mg/kg administered daily
Group II: Matching PlaceboPlacebo Group1 Intervention
Administration: Subcutaneous injection
Dosage: Daily subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zilucoplan
2024
Completed Phase 3
~700
Find a Location
Who is running the clinical trial?
Ra PharmaceuticalsIndustry Sponsor
7 Previous Clinical Trials
494 Total Patients Enrolled
Merit E. Cudkowicz, MDLead Sponsor
7 Previous Clinical Trials
2,692 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
2,692 Patients Enrolled for Amyotrophic Lateral Sclerosis
Merit CudkowiczPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
161 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
161 Patients Enrolled for Amyotrophic Lateral Sclerosis