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Monoclonal Antibodies

Rozanolixizumab 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from end of the 6-week treatment cycle (day 43) to the next 6-week treatment cycle (day 1), assessed up to 2.5 years
Awards & highlights

Study Summary

This trial will test if an additional 6 weeks of treatment with rozanolixizumab is safe and effective for people with generalized myasthenia gravis.

Who is the study for?
This trial is for people with generalized myasthenia gravis (gMG) who weigh at least 35 kg. Participants must have completed a prior related study or needed rescue therapy during it, and cannot join if they've had severe reactions to similar medications, certain infections like TB, or are planning to receive live vaccines soon.Check my eligibility
What is being tested?
The trial is testing additional 6-week treatment cycles of Rozanolixizumab in patients with gMG. It aims to evaluate the safety and effectiveness of this medication over repeated doses.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system modulation such as infusion-related responses, increased risk of infections due to immunosuppression, and possible hypersensitivity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from end of the 6-week treatment cycle (day 43) to the next 6-week treatment cycle (day 1), assessed up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from end of the 6-week treatment cycle (day 43) to the next 6-week treatment cycle (day 1), assessed up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with TEAEs leading to withdrawal of investigational medicinal product (IMP)
Percentage of participants with treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar symptoms' score within one treatment cycle
Fatigue
Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' score within one treatment cycle
+6 more

Side effects data

From 2021 Phase 3 trial • 71 Patients • NCT04124965
29%
Headache
17%
Diarrhoea
12%
Blood immunoglobulin G decreased
12%
Nausea
10%
Vomiting
10%
Nasopharyngitis
10%
Rash
7%
Back pain
7%
Pyrexia
5%
Abdominal pain
5%
Urinary tract infection
5%
Hypogammaglobulinaemia
2%
Pericarditis
2%
Myasthenia gravis
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rozanolixizumab ~10 mg/kg
Rozanolixizumab ~7 mg/kg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Rozanolixizumab dosage regimen 2Experimental Treatment1 Intervention
Study participants randomized/assigned to dosage regimen 2 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.
Group II: Rozanolixizumab dosage regimen 1Experimental Treatment1 Intervention
Study participants randomized/assigned to dosage regimen 1 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rozanolixizumab
2019
Completed Phase 3
~560

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,271 Total Patients Enrolled
7 Trials studying Myasthenia Gravis
492 Patients Enrolled for Myasthenia Gravis
UCB CaresStudy Director001 844 599 22733 (UCB)
205 Previous Clinical Trials
44,798 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
841 Patients Enrolled for Myasthenia Gravis

Media Library

Rozanolixizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04650854 — Phase 3
Myasthenia Gravis Research Study Groups: Rozanolixizumab dosage regimen 1, Rozanolixizumab dosage regimen 2
Myasthenia Gravis Clinical Trial 2023: Rozanolixizumab Highlights & Side Effects. Trial Name: NCT04650854 — Phase 3
Rozanolixizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04650854 — Phase 3

Frequently Asked Questions

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

Does this clinical trial have any predecessors?

"There are 4 ongoing clinical trials for Rozanolixizumab in 21 cities and 26 countries. The earliest trial was held in 2020 and involved 43 patients. 7 trials have been completed since then."

Answered by AI

How many people are eligible to participate in this clinical trial?

"Presently, this clinical trial is not looking for new participants. The study was first posted on February 3rd, 2021 and last updated November 10th, 2022. There are other active trials searching for patients with myasthenia gravis- 87 in total. Additionally, there are 4 different trials involving Rozanolixizumab that have open recruitment at the moment."

Answered by AI

Has Rozanolixizumab completed the necessary steps for FDA approval?

"Rozanolixizumab's safety is estimated to be a 3. This assessment comes from the fact that Rozanolixizumab is in Phase 3 clinical trials, which implies that while there is data supporting efficacy, there are also multiple rounds of data affirming its safety."

Answered by AI

What other data exists on Rozanolixizumab?

"The clinical history of Rozanolixizumab begins in 2020 at Tp0004 20051. So far, there have been seven completed trials and four more are still ongoing. The majority of the active trials for this medication are based in Montreal and California."

Answered by AI

Are we still taking people in for this test?

"Unfortunately, this particular clinical trial is no longer enrolling patients. The study was first posted on February 3rd, 2021 and had its last edit on November 10th, 2022. There are other active trials though; right now, 87 studies are actively recruiting patients with myasthenia gravis and 4 studies are still admitting participants for Rozanolixizumab."

Answered by AI

What does this research hope to achieve?

"According to the trial sponsor, UCB Biopharma SRL, the primary objective of this study is to measure the percentage of participants who experience side effects that lead to withdrawal from the investigational medication. This will be measured over a time span of From Baseline (Day 1) to End of Study (average of 20 months). Additionally, secondary outcomes including Time between consecutive treatment cycles and Change from Baseline (Day 1) to Day 43 in Myasthenia gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' score within one treatment cycle will also be measured."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
2021. "A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04650854.
~40 spots leftby Apr 2025
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