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Monoclonal Antibodies

Zilucoplan for Myasthenia Gravis (RAISE-XT Trial)

Phase 3
Waitlist Available
Research Sponsored by Ra Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) to safety follow-up visit (up to 36 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing zilucoplan, a medication for muscle weakness, in patients with generalized Myasthenia Gravis who were in previous studies. It aims to see if the drug is safe and effective over time by calming the immune system to prevent it from attacking muscles. Zilucoplan is currently being tested for its potential to improve disease control in generalized myasthenia gravis.

Who is the study for?
This trial is for individuals with generalized Myasthenia Gravis (gMG) who have already completed a qualifying study involving zilucoplan. They should not be part of any other clinical trials testing new treatments, although observational studies are okay.
What is being tested?
The RAISE-XT study is testing the long-term effects of zilucoplan on people with gMG. It's an open-label extension, meaning everyone knows they're getting zilucoplan and there's no placebo comparison.
What are the potential side effects?
While specific side effects aren't listed here, common ones for drugs like zilucoplan may include injection site reactions, muscle or joint pain, headaches, and potential immune system impacts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) to safety follow-up visit (up to 36 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) to safety follow-up visit (up to 36 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events (TEAEs)
Secondary study objectives
Change from Baseline to Week 12 in the Myasthenia Gravis - Quality of Life revised (MG-QOL15r) Score
Change from Baseline to Week 12 in the Myasthenia Gravis Composite (MGC) Score
Change from Baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
+1 more

Side effects data

From 2021 Phase 3 trial • 174 Patients • NCT04115293
16%
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%
Pulmonary embolism
1%
Angioedema
1%
COVID-19
1%
Pneumonia
1%
Basal cell carcinoma
1%
Oesophageal candidiasis
1%
Oral candidiasis
1%
COVID-19 pneumonia
1%
Sepsis
1%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Zilucoplan 0.3 mg/kg

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: 0.3 mg/kg zilucoplan (RA101495)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
zilucoplan (RA101495)
2019
Completed Phase 3
~220

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myasthenia Gravis (MG) include acetylcholinesterase inhibitors, immunosuppressive drugs, and complement inhibitors. Acetylcholinesterase inhibitors, such as pyridostigmine, increase the availability of acetylcholine at the neuromuscular junction, improving muscle contraction. Immunosuppressive drugs like corticosteroids and azathioprine reduce the immune system's attack on acetylcholine receptors, decreasing symptoms. Complement inhibitors, such as Zilucoplan, block the complement system's role in the destruction of acetylcholine receptors, preventing further muscle weakness. These treatments are crucial for MG patients as they target different aspects of the disease's pathophysiology, offering symptomatic relief and slowing disease progression.
Update in immunosuppressive therapy of myasthenia gravis.[Myasthenia gravis].

Find a Location

Who is running the clinical trial?

Ra PharmaceuticalsLead Sponsor
7 Previous Clinical Trials
456 Total Patients Enrolled
2 Trials studying Myasthenia Gravis
219 Patients Enrolled for Myasthenia Gravis
Ra Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
193 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
174 Patients Enrolled for Myasthenia Gravis
UCB CaresStudy Director001 844 599 2273
215 Previous Clinical Trials
46,251 Total Patients Enrolled
13 Trials studying Myasthenia Gravis
851 Patients Enrolled for Myasthenia Gravis

Media Library

Zilucoplan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04225871 — Phase 3
Myasthenia Gravis Research Study Groups: 0.3 mg/kg zilucoplan (RA101495)
Myasthenia Gravis Clinical Trial 2023: Zilucoplan Highlights & Side Effects. Trial Name: NCT04225871 — Phase 3
Zilucoplan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04225871 — Phase 3
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