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Monoclonal Antibodies

Zilucoplan for Myasthenia Gravis (ziMyG Trial)

Phase 2 & 3
Recruiting
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 (day 29)
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to study how a drug called zilucoplan works in children with generalized myasthenia gravis, looking at its effects on the body, safety, and how well it works

Who is the study for?
This trial is for children and teenagers aged 2 to less than 18 with generalized myasthenia gravis (gMG), a condition causing muscle weakness. They must have confirmed gMG through a specific blood test, show documented muscle weakness, and meet certain criteria on the MGFA Clinical Classification scale. Participants also need an up-to-date meningococcal vaccine or agree to take antibiotics until properly vaccinated.
What is being tested?
The study tests Zilucoplan, administered subcutaneously, to evaluate its effects on pediatric patients with gMG. It aims to understand how the drug works in young bodies (pharmacokinetics/dynamics), its safety, tolerability, potential immune response it may cause (immunogenicity), and overall effectiveness in improving symptoms.
What are the potential side effects?
While not explicitly listed here, common side effects of drugs like Zilucoplan could include injection site reactions such as redness or pain, flu-like symptoms including fever or chills, potential allergic reactions ranging from mild rashes to more severe responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 (day 29)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 (day 29) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in complement component 5 (C5) levels at Week 4 (Day 29)
Change from Baseline in sheep red blood cell (sRBC) lysis at Week 4 (Day 29)
Plasma concentrations of zilucoplan (ZLP) sampled at Week 4 (Day 29)
Secondary study objectives
Change in MG-activities of daily living (MG-ADL) score from Baseline to Week 4 (Day 29).
Change in Pediatric Quality of Life Inventory (PedsQoL), Version 4 domain scores from Baseline to Week 4 (Day 29)
Change in Quantitative MG (QMG) score from Baseline to Week 4 (Day 29)
+6 more

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%
Dysphagia
10%
Dizziness
8%
Nausea
7%
Diarrhoea
7%
Dysarthria
7%
Oedema peripheral
7%
Cough
6%
Dyspnoea
6%
Rash
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%
Traumatic haematoma
1%
Device malfunction
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Zilucoplan ArmExperimental Treatment1 Intervention
Study participants will receive zilucoplan in pre-defined dose based on their weight.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zilucoplan
2020
Completed Phase 3
~680

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
113 Previous Clinical Trials
23,141 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
694 Patients Enrolled for Myasthenia Gravis
UCB CaresStudy Director001 844 599 2273
217 Previous Clinical Trials
46,505 Total Patients Enrolled
13 Trials studying Myasthenia Gravis
1,043 Patients Enrolled for Myasthenia Gravis
~5 spots leftby Nov 2026
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