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Monoclonal Antibodies

Zilucoplan Arm 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

ziMyG Trial 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.Check my eligibility

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.See study design

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.

ziMyG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4 (day 29)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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%

Neuromyopathy

18%

Injection site bruising

15%

Injection site pain

14%

Fatigue

11%

Constipation

11%

Headache

10%

Dizziness

10%

Dysphagia

Nausea

Diarrhoea

Cough

Dysarthria

Oedema peripheral

Rash

Contusion

Anxiety

Dyspnoea

Pruritus

Respiratory Failure

Tension headache

Urinary tract infection

Decreased appetite

Arthralgia

Hypertension

Pain in extremity

Injection site reaction

Salivary hypersecretion

Pneumonia aspiration

Pulmonary embolism

COVID-19

Post-traumatic pain

Generalised oedema

Vomiting

Faecaloma

COVID-19 pneumonia

Pneumonia

Oesophageal carcinoma

Device malfunction

Hepatic enzyme increased

Cardiac arrest

Cardiac failure congestive

Supraventricular tachycardia

Deep vein thrombosis

Traumatic haematoma

Tinnitus

Increased upper airway secretion

Pancreatitis

Pneumoperitoneum

Chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Zilucoplan

Matching Placebo

ziMyG 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

102 Previous Clinical Trials

21,630 Total Patients Enrolled

7 Trials studying Myasthenia Gravis

649 Patients Enrolled for Myasthenia Gravis

UCB CaresStudy Director001 844 599 2273

205 Previous Clinical Trials

44,990 Total Patients Enrolled

10 Trials studying Myasthenia Gravis

998 Patients Enrolled for Myasthenia Gravis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment criteria for this study inclusive of individuals aged 55 and above?

"This research study is open to participants aged 12 to under 17 years."

Answered by AI

What are the eligibility criteria for participation in this clinical study?

"Individuals aged between 12 and 17 years diagnosed with myasthenia gravis are eligible to participate in this study, which aims to enroll approximately 8 participants."

Answered by AI

Are potential participants currently able to apply for enrollment in this study?

"As per the details available on clinicaltrials.gov, patient recruitment is ongoing for this research study. The trial was initially listed on 4/25/2024 and recently revised as of 4/11/2024."

Answered by AI

What is the upper limit of individuals enrolled in this research endeavor?

"Affirmative. Information from clinicaltrials.gov confirms that this investigation is actively enrolling subjects. Initially shared on April 25, 2024 and most recently revised on April 11, 2024, the study aims to recruit a total of 8 participants dispersed among 3 locations."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The primary aim of this clinical investigation, which will be observed at approximately Week 4 (Day 29), is to evaluate the plasma levels of zilucoplan (ZLP) collected on Day 29. Secondary goals encompass the incidence of treatment-related severe adverse events (TESAEs); these are outlined as any negative medical occurrence that could lead to death, pose a life-threatening situation, necessitate hospitalization or extend an existing stay in a healthcare facility, result in lasting disability/incapacity, present as a congenital anomaly/birth defect or signify significant medical incidents. Additional secondary objectives include occurrences of treatment-linked adverse events leading to"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

2024. "A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06055959.

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