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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

RAISE-XT Trial Summary

This trial is to see if a drug is effective and safe for people with gMG, a disease that causes muscle weakness.

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.Check my eligibility
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.See study design
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.

RAISE-XT Trial 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

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)
Secondary outcome measures
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%
Oral candidiasis
1%
Aphthous ulcer
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

RAISE-XT 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

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
205 Previous Clinical Trials
44,763 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
806 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

Frequently Asked Questions

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

What other zilucoplan (RA101495) studies have been completed?

"The year 2019 saw the first clinical trials for zilucoplan (RA101495), with 6 completed studies to date. Right now, 3 more are ongoing; a significant portion of these taking place in Los Angeles."

Answered by AI

Is this a new kind of clinical trial?

"There are currently 3 active trials for zilucoplan (RA101495) across 81 cities and 10 countries. The earliest trial for zilucoplan (RA101495) was run in 2019. The trial, sponsored by Ra Pharmaceuticals, Inc., involved 200 participants and completed its Phase 3 drug approval stage. Since 2019 years, 6 studies have been completed."

Answered by AI

Are we currently able to enroll patients in this research project?

"This clinical trial is not currently recruiting patients. The first posting for this trial was on December 23, 2019, and the last update was on November 3, 2022. There are presently 87 studies actively looking for patients with myasthenia gravis, generalized and 3 studies for zilucoplan (RA101495) enrolling patients."

Answered by AI

What is zilucoplan's (RA101495) standing with the FDA?

"Zilucoplan (RA101495) has been given a rating of 3 for safety by our Power team. This is because it is currently in Phase 3 trials, meaning that there is some evidence to support its efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

At how many different facilities is this research being conducted?

"Out of the 66 different hospitals and clinics participating in this study, patients are being recruited from locations including Los Angeles, Chapel Hill, San Francisco and 63 other sites. To limit travel demands, it is recommended that you select a trial site close to your home."

Answered by AI

What is the largest number of people that can be a part of this trial?

"Unfortunately, this trial is no longer recruiting patients. The study was initially posted on December 23rd, 2019 but the most recent update was on November 3rd, 2022. There are 87 other clinical trials searching for participants with myasthenia gravis and 3 studies concerning zilucoplan (RA101495) if you're interested in alternative options."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
2019. "Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04225871.
All > Myasthenia Gravis
~63 spots leftby May 2026
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