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Monoclonal Antibodies

Zilucoplan for Myasthenia Gravis

Phase 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
Study participants on commercial ZLP need to receive ZLP per the approved local labeling
Study participant must be at least 18 years of age at the time of signing the informed consent form
Must not have
Female participants who are breastfeeding, pregnant, or plan to become pregnant during the study
Study participant has a clinically relevant active infection or a history of serious infection within 6 weeks before Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 (day 1) to visit 8 (day 14)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to test how well and how safe it is for patients to use the zilucoplan auto-injector on themselves.

Who is the study for?
This trial is for adults with generalized Myasthenia Gravis (gMG) who are either currently in a zilucoplan study or have been on a stable dose of commercial zilucoplan. Participants must be vaccinated against meningitis, not pregnant, willing to use contraception, and able to self-administer the drug using an auto-injector.
What is being tested?
The trial is testing how effective and safe it is for participants with gMG to use an auto-injector device to self-administer zilucoplan, which is a medication used to treat their condition.
What are the potential side effects?
While specific side effects are not listed here, typically such trials would monitor for any adverse reactions related to the drug's administration including injection site reactions, potential allergic responses, and general medication-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking ZLP as prescribed.
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I am 18 years old or older.
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I am a woman who can have children and have a negative pregnancy test.
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I have been diagnosed with generalized Myasthenia Gravis.
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I am currently in the ZLP RA101495-02.302 study or have been on a stable dose of commercial ZLP for at least 1 month.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
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I haven't had a serious infection or an active one in the last 6 weeks.
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My liver condition is stable, as assessed by my doctor.
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I have had meningococcal disease before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 (day 1) to visit 8 (day 14)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (day 1) to visit 8 (day 14) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of effective self-administrations of zilucoplan using the zilucoplan-auto-injector (ZLP-AI) from Visit 1 to Visit 8
Secondary study objectives
Occurrence of nonserious adverse device effects (ADE) during the course of the study
Occurrence of serious adverse device effects (SADE) during the course of the study
Occurrence of serious adverse events (SAEs) during the course of the study
+3 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%
Device malfunction
1%
Deep vein thrombosis
1%
Oesophageal carcinoma
1%
Traumatic haematoma
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-auto-injector (ZLP-AI)Experimental Treatment1 Intervention
Study participants will self-administer zilucoplan (ZLP) based on their body weight using auto-injector (AI).
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
23,124 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
677 Patients Enrolled for Myasthenia Gravis
UCB CaresStudy Director001 844 599 2273
217 Previous Clinical Trials
46,488 Total Patients Enrolled
13 Trials studying Myasthenia Gravis
1,026 Patients Enrolled for Myasthenia Gravis
~0 spots leftby Dec 2024
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