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Monoclonal Antibodies

Zilucoplan for Myasthenia Gravis (ziMyG+ Trial)

Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Participant must be ≥ 12 years of age at the time of signing the Informed Consent/Assent according to local regulation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) to safety follow-up (up to week 60)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to evaluate the safety and tolerability of giving Zilucoplan through daily injections for an extra 52 weeks in children.

Who is the study for?
This trial is for pediatric patients with generalized Myasthenia Gravis who are at least 2 years old and have completed the MG0014 study. They must be willing to get booster shots against meningococcal infections if needed.
What is being tested?
The trial is testing Zilucoplan, a medication given by daily injection under the skin, over an additional year to see how safe and tolerable it is for long-term use in children with muscle weakness due to Myasthenia Gravis.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with medications like Zilucoplan may include reactions at the injection site, headache, nausea or potential risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 12 years old or older and can legally consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) to safety follow-up (up to week 60)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) to safety follow-up (up to week 60) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Occurence of treatment emergent adverse events during the course of the study
Occurence of treatment-emergent advserse events leading to permanent withdrawal of investigational medicinal product
Occurence of treatment-emergent infections
+1 more
Secondary study objectives
Blood complement component 5 (C5) levels at Week 52
Myasthenia Gravis Activity of Daily Living (MG-ADL) score at Week 52
Plasma concentration of Zilucoplan at Week 52
+2 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%
Constipation
11%
Headache
10%
Dysphagia
10%
Dizziness
8%
Nausea
7%
Cough
7%
Diarrhoea
7%
Oedema peripheral
7%
Dysarthria
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Zilucoplan ArmExperimental Treatment1 Intervention
Study participants will receive Zilucoplan at a pre-defined dose based on their weight.
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?

UCB Biopharma SRLLead Sponsor
115 Previous Clinical Trials
22,898 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
694 Patients Enrolled for Myasthenia Gravis
UCB CaresStudy Director001 844 599 2273 (UCB)
219 Previous Clinical Trials
46,272 Total Patients Enrolled
13 Trials studying Myasthenia Gravis
1,043 Patients Enrolled for Myasthenia Gravis
~5 spots leftby Oct 2027
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