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Complement Inhibitor
Subcutaneous Zilucoplan for Myasthenia Gravis
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 has a documented diagnosis of gMG (Myasthenia Gravis Foundation of America; MGFA Class II-IVa) at Screening based on participant history and supported by previous evaluations
Participant has had no change in immunosuppressive therapy, including dose, during the Screening Period and no change in immunosuppressive therapy is anticipated to occur during the 12-week Main Treatment Period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) to safety follow-up visit of main treatment period (up to week 18)
Awards & highlights
Study Summary
This trial evaluates if switching from IV to SC medication is safe and well-tolerated for people with gMG.
Who is the study for?
This trial is for people with generalized myasthenia gravis who were previously on IV C5 inhibitors and are willing to switch to subcutaneous Zilucoplan. They should have stable medication doses, be vaccinated against meningococcal disease, not pregnant or breastfeeding, agree to use contraception, and have no recent surgeries or certain medical conditions.Check my eligibility
What is being tested?
The study tests the safety of switching from intravenous C5 inhibitors to a new method using subcutaneous injections of Zilucoplan in patients with generalized myasthenia gravis. It aims to see if this change maintains their muscle strength without causing harm.See study design
What are the potential side effects?
While specific side effects for Zilucoplan aren't listed here, similar medications may cause injection site reactions, infections due to immune system suppression, allergic reactions, or changes in liver function tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Myasthenia Gravis, classified as Class II-IVa.
Select...
My immunosuppressive therapy has been stable and will remain so for the next 12 weeks.
Select...
My corticosteroid dose has been stable and will remain so for the next 12 weeks.
Select...
I am willing to change my current IV treatment to a subcutaneous injection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (day 1) to safety follow-up visit of main treatment period (up to week 18)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) to safety follow-up visit of main treatment period (up to week 18)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs) leading to withdrawal of study medication over the Main Treatment Period
Incidence of treatment-emergent adverse events (TEAEs) over the Main Treatment Period
Secondary outcome measures
Change from Baseline to Week 12 in MG ADL score
Change from Baseline to Week 12 in the QMG score
Incidence of serious treatment-emergent adverse events (serious TEAEs) over the Main Treatment Period
+1 moreSide effects data
From 2021 Phase 3 trial • 174 Patients • NCT0411529316%
Injection site bruising
15%
Headache
10%
Diarrhoea
9%
Injection site pain
9%
Myasthenia gravis
8%
Urinary tract infection
8%
Contusion
7%
Lipase increased
6%
Nasopharyngitis
6%
Amylase increased
3%
Rash
3%
Vomiting
1%
Aphthous ulcer
1%
Oral candidiasis
1%
Basal cell carcinoma
1%
COVID-19 pneumonia
1%
Pneumonia
1%
Oesophageal candidiasis
1%
Angioedema
1%
Pulmonary embolism
1%
COVID-19
1%
Sepsis
1%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Zilucoplan 0.3 mg/kg
Trial Design
1Treatment groups
Experimental Treatment
Group I: 0.3 mg/kg zilucoplan (RA101495)Experimental Treatment1 Intervention
Study participants will be treated with subcutaneous zilucoplan (0.3mg/kg/day)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
zilucoplan (RA101495)
2019
Completed Phase 3
~220
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,410 Total Patients Enrolled
7 Trials studying Myasthenia Gravis
631 Patients Enrolled for Myasthenia Gravis
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,937 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
980 Patients Enrolled for Myasthenia Gravis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My daily activity level hasn't changed much recently due to my myasthenia gravis.Your liver enzymes (ALT, AST, or ALP) are more than 2.5 times the normal limit.Your heart's QTc interval is too long, which may cause heart rhythm problems.I have had or will have surgery to remove my thymus gland soon.My corticosteroid dose has been stable and will remain so for the next 12 weeks.I've been on an approved IV treatment for myasthenia gravis for at least 3 or 4 months, and my condition is stable.I have been treated with rituximab recently or will be during the study.My liver condition is stable and does not have serious complications.You have a documented history of testing positive for certain autoantibodies before the screening.I had surgery with general anesthesia within the last 2 weeks or will have one in the next 12 weeks.I have been treated with IVIG, SC immunoglobulin, or plasma exchange recently or am on a chronic regimen.Your bilirubin level is too high, unless it's only the direct bilirubin that's high and the total bilirubin is within a certain range.I haven't taken any experimental drugs recently.I have been diagnosed with Myasthenia Gravis, classified as Class II-IVa.My immunosuppressive therapy has been stable and will remain so for the next 12 weeks.I've had the meningococcal vaccine and serotype B vaccine over 14 days ago.I am either male or female.You have tried to hurt yourself on purpose in the past, or have recently thought seriously about doing so.I agree to use birth control and not donate sperm during and for 40 days after the study.I am able to understand and sign the consent form.I am not pregnant or breastfeeding, and if I can have children, I agree to use contraception during and after the study.I am willing to change my current IV treatment to a subcutaneous injection.I have not had a serious infection or needed IV antibiotics in the last 4 weeks.I have had meningococcal disease before.You have a positive blood test for muscle-specific kinase.I haven't needed cancer treatment for any other cancer than skin cancer in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: 0.3 mg/kg zilucoplan (RA101495)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a threat to human health posed by zilucoplan (RA101495) at 0.3 mg/kg?
"Zilucoplan (RA101495), dosed at 0.3 mg/kg, is considered to be a safe medication with a score of 3. This is due to the fact that this is a phase 3 trial, meaning that there is both some efficacy data as well as multiple rounds of safety data supporting its use."
Answered by AI
Does this research involve any participants above the age of 60?
"Eligibility for this clinical trial includes patients aged 18 to 85. If you are not in this age bracket, there are 12 other trials for people under 18 and 72 for patients over 65."
Answered by AI
What are we looking to find out by conducting this research?
"The purpose of this trial is to assess the incidence of adverse events leading to withdrawal of study medication over a From Baseline (Day 1) to Safety Follow-Up Visit (up to 18 weeks) timeframe. Secondary outcomes include Change from Baseline to Week 12 in the QMG score and the Incidence of serious treatment-emergent adverse events (serious TEAEs)."
Answered by AI
Are we still able to enroll more participants in this research?
"Yes, this is accurate. The website clinicaltrials.gov provides information that this particular trial is still looking for participants. The trial was put up on the site on October 31st, 2020 and was updated on November 2nd, 2020."
Answered by AI
Who does this trial accept as participants?
"The eligibility requirements for this study are as follows: the patient must have myasthenia gravis, be of age between 18 and 85, and have generalized myasthenia gravis. A total of 20 individuals are needed for this clinical trial."
Answered by AI
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