Rozanolixizumab for Myasthenia Gravis
(MyVision Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called rozanolixizumab to determine its effectiveness for people with Ocular Myasthenia Gravis (oMG), a condition that weakens the muscles around the eyes. The study compares rozanolixizumab to a placebo (a harmless pill with no treatment) to assess its effectiveness and safety. Participants will receive either the actual treatment or a placebo for up to six weeks. Suitable candidates have been diagnosed with oMG, exhibit eye muscle weakness, and have noticed these symptoms within the last three years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.
Is there any evidence suggesting that rozanolixizumab is likely to be safe for humans?
Research has shown that rozanolixizumab is generally well-tolerated by people with generalized myasthenia gravis (MG). Studies have found that most side effects are mild to moderate. Common side effects include headaches, infections, diarrhea, fever, allergic reactions, and nausea, affecting at least 10% of participants who took rozanolixizumab.
Additionally, a long-term study found that repeated treatments with rozanolixizumab were safe for patients. Safety remained consistent even after several treatment cycles. The FDA has approved the treatment for use in adults with generalized MG, which supports its safety for this condition.12345Why do researchers think this study treatment might be promising for Myasthenia Gravis?
Rozanolixizumab is unique because it targets the neonatal Fc receptor (FcRn), which plays a role in regulating the levels of antibodies in the body. Unlike current treatments for myasthenia gravis, which often involve broad immunosuppression or acetylcholinesterase inhibitors, rozanolixizumab specifically reduces the antibodies responsible for muscle weakness. This targeted approach can potentially offer more precise control of symptoms with fewer side effects. Researchers are excited about this treatment because it represents a novel mechanism that might provide significant relief for patients who haven't responded well to existing therapies.
What evidence suggests that rozanolixizumab might be an effective treatment for Myasthenia Gravis?
Research has shown that rozanolixizumab may help treat myasthenia gravis, a condition that causes muscle weakness. One study found that patients who took rozanolixizumab experienced a noticeable improvement in their symptoms, with an average improvement of more than 2.5 points at various doses. In this trial, participants will receive either rozanolixizumab or a placebo at random. Another study demonstrated that patients treated with rozanolixizumab had a significant reduction in symptom scores compared to those who received a placebo. Rozanolixizumab works by lowering levels of a specific antibody that contributes to the disease. Early results suggest it can lead to significant improvements within a few weeks of starting treatment.12678
Are You a Good Fit for This Trial?
This trial is for adults (18+) with ocular myasthenia gravis, meaning their muscle weakness only affects the eyes and not other body parts. Participants must have certain test results confirming the diagnosis and either be on stable treatment or untreated. They need to weigh at least 35 kg.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rozanolixizumab or placebo for up to 6 weeks
Observation
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Rozanolixizumab
Trial Overview
The study compares rozanolixizumab, a new medication, against a placebo in people with ocular myasthenia gravis to see if it helps improve symptoms. Participants are randomly assigned to receive either the drug or placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
After the Screening Period, participants will enter the study Intervention Period and will be administered study drug for up to 6 weeks. Prior to entering the Intervention Period, study participants will be randomized at a 1:1 ratio and will receive rozanolixizumab. At the End of Treatment Visit, participants will enter an Observation Period of 4 to 7 weeks with an opportunity to transition to an open-label extension study.
After the Screening Period, participants will enter the study Intervention Period and will be administered study drug for up to 6 weeks. Prior to entering the Intervention Period, study participants will be randomized at a 1:1 ratio and will receive placebo. At the End of Treatment Visit, participants will enter an Observation Period of 4 to 7 weeks with an opportunity to transition to an open-label extension study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
Jean-Christophe Tellier
UCB Biopharma SRL
Chief Executive Officer since 2015
MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD
Dr. Iris Loew-Friedrich
UCB Biopharma SRL
Chief Medical Officer since 2014
MD from University of Leuven, PhD in Medical Sciences from University of Leuven
Citations
NCT03971422 | A Study to Test Efficacy and Safety of ...
The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with ...
Clinical Trial Data For RYSTIGGO® (rozanolixizumab-noli)
RYSTIGGO demonstrated statistically significant and clinically meaningful improvements vs placebo in MG-ADL total score at Week 6 (-3.4 vs -0.8; P<0.001).
the randomized open-label extension MG0004 study - PMC
In the Phase 3 MycarinG study (NCT03971422), six once-weekly subcutaneous infusions of rozanolixizumab significantly improved myasthenia gravis ...
UCB presents efficacy and safety results for zilucoplan ...
Rozanolixizumab demonstrated a placebo-corrected mean improvement of 2.586 points at the ~7 mg/kg dose and 2.619 points in the MG-ADL at the ~10 mg/kg dose. ...
Full article: Rozanolixizumab for Myasthenia Gravis
It found that rozanolixizumab was among the medications associated with significant clinical improvement within 1 to 4 weeks post-initiation, ...
RYSTIGGO[®]▼(rozanolixizumab), for generalized ...
Safety and efficacy of rozanolixizumab in patients with generalized myasthenia gravis (MycarinG): a randomised, double-blind, placebo controlled, adaptive ...
Long-term safety of cyclical rozanolixizumab in patients with ...
A Phase 3 study called MycarinG has shown that one 6-week cycle of rozanolixizumab in adult patients with gMG had few side effects and reduced ...
Safety Information For RYSTIGGO® (rozanolixizumab-noli)
The most common adverse reactions (≥10%) in adults treated with RYSTIGGO were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.1
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