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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 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 weeks for reporting.

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 • NCT04436497
32%
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
~30 spots leftby Jan 2026