Category: Rozanolixizumab ucb

Study record managers: refer to the Data Element Definitions if submitting registration or results information. Drug: Rozanolixizumab Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages dose 1 and dose 2 in dosage regimen 1 and 2.

Other Name: UCB Experimental: Dosage Regimen 2 Subjects randomized in dosage regimen 2 will receive assigned dosages of rozanolixizumab at pre-specified time points during Treatment Period.

rozanolixizumab ucb

Other: Placebo Subjects will receive placebo at pre-specified time points. The score ranges from 0 to 24, with a higher score indicating more disability.

Phase 2 Study Shows Rozanolixizumab Is Safe and Effective in Alleviating MG Symptoms

The score ranges from 0 to 50, with lower scores indicating lower disease activity. The score ranges from 0 to 39, with lower scores indicating lower disease activity. The study participant will be asked to choose the response option that best describes the severity of ocular, bulbar, and respiratory symptoms over the past 7 days using a 4-point Likert scale "none" to "severe" and how frequently they experience physical fatigue and muscle weakness fatigability over the past 7 days using a 5-point Likert scale "none of the time" to "all of the time"respectively.

The MG symptoms PRO instrument consists of 42 items across 5 scales: ocular symptoms items ; bulbar symptoms items ; respiratory symptoms items ; physical fatigue items and muscle weakness fatigability items An Adverse Event AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal investigational product, whether or not related to the medicinal investigational product.

A Treatment emergent adverse event TEAE is defined as any event that was not present prior to the first administration of IMP or any unresolved event already present before the first administration of IMP that worsens in intensity following exposure to treatment. One of the secondary outcome measures is to assess safety and tolerability of the IMP in the MG patients. A TEAE is defined as any event that was not present prior to the first administration of IMP or any unresolved event already present before the first administration of IMP that worsens in intensity following exposure to treatment.

Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

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Search for terms x. COVID is an emerging, rapidly evolving situation. Save this study. Warning You have reached the maximum number of saved studies A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

Read our disclaimer for details. Last Update Posted : March 30, See Contacts and Locations. Study Description. The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis MG. FDA Resources. Arms and Interventions. Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages dose 1 and dose 2 in dosage regimen 1 and 2.

Subjects randomized in dosage regimen 2 will receive assigned dosages of rozanolixizumab at pre-specified time points during Treatment Period.

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Subjects randomized to this arm will receive placebo.This website uses a limited number of cookies to improve your browsing experience. For further information including how to withdraw consentplease refer to our Cookie Policy. By clicking Accept below or continuing to use this website including closing this messageyou confirm that you have read and consent to our use of cookies as detailed in our Cookie Policy.

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All rights reserved. Home UCB in the U. Leadership Team Patients Patients U. Clinical Trials Innovation Products U. Innovation Pipeline Responsibility U. Newsroom UCB U.Investigational antibody rozanolixizumab UCB has proven safe and effective in treating symptoms associated with myasthenia gravis MGPhase 2 results show.

Rozanolixizumab acts by binding to human neonatal Fc receptor FcRna molecule that circulates in the bloodstream and binds to the disease-causing IgG autoantibody, inhibiting its degradation.

In MG, IgG autoantibodies mistakenly attack healthy cells and tissues, causing weakness and fatigue of voluntary muscles. University of Toronto researchers designed the randomized, placebo-controlled, proof-of-concept MG trial to assess the clinical efficacy of rozanolixizumab in patients with generalized moderate to severe MG.

Results showed that subcutaneous infusion of rozanolixizumab was safe, well-tolerated and effective during the entire study period. Clinical benefits were seen across all. The QMG was After dosing period two, participants on active treatment showed a reduction in total IgG levels and IgG autoantibody levels. Safety and tolerability were confirmed in dosing period one.

Although patients more frequently experienced headaches The team will present the full data of the MG trial at a medical congress and will submit the work for publication in a peer-reviewed journal. UCB is also testing rozanolixizumab for the treatment of other diseases. The company will initiate a Phase 2 trial in patients with chronic inflammatory demyelinating polyneuropathy CIDP in the first quarter of Immune thrombocytopenia ITPor idiopathic thrombocytopenic purpurais also a target for rozanolixizumab therapy.

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rozanolixizumab ucb

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Ok Read more.Rozanolixizumab UCB is an investigational humanized monoclonal IgG antibody being developed by UCB for the treatment of myasthenia gravis MGa neuromuscular condition thought to be triggered by an autoimmune response.

In addition to MG, Rozanolixizumab is also being tested as a potential therapy for patients with idiopathic thrombocytopenic purpuraalso known as immune thrombocytopenia ITP.

High concentrations of pathogenic IgG autoantibodies in the circulation occur due to the action of the neonatal Fc receptor FcRn that bind to IgG, inhibiting its degradation.

Rozanolixizumab works by binding with high-affinity to human neonatal Fc receptor FcRnselectively inhibiting IgG rescue and recycling. By reducing the serum levels of IgG, it is expected that Rozanolixizumab will help reduce the symptoms of MG. Preliminary results from the trial presented at the Peripheral Nerve Society Annual Meetingshowed that Rozanolixizumab effectively reduced serum IgG, with under-the-skin administration generally being better tolerated than injection into the bloodstream.

To further these observations, a Phase 2, multi-center, randomized, double-blind, placebo-controlled study NCT was initiated to test the effectiveness, safety, and tolerability of Rozanolixizumab in patients with moderate-to-severe MG. The study is currently recruiting 42 patients in the U. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

Never disregard professional medical advice or delay in seeking it because of something you have read on this website. Author Details. Margarida Azevedo, MSc. She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies. Pin It on Pinterest. We use cookies to ensure that we give you the best experience on our website.

If you continue to use this site we will assume that you are happy with it.

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We never use your cookies for creepy ad retargeting that follows you around the web. Ok Read more.Erratum in Sci Transl Med. Comment in Transplantation. Pathogenic immunoglobulin G IgG autoantibodies characterize some human autoimmune diseases; their high concentration and long half-life are dependent on recycling by the neonatal Fc receptor FcRn.

Inhibition of FcRn is an attractive new treatment concept for IgG-mediated autoimmune diseases. We also report a first-in-human, randomized, double-blind, placebo-controlled, dose-escalating study of intravenous IV or subcutaneous SC rozanolixizumab in healthy subjects NCT The primary objective was to evaluate safety and tolerability.

Secondary objectives were assessment of rozanolixizumab pharmacokinetics and pharmacodynamics, including effects on circulating IgG concentrations. The most frequent treatment-emergent adverse event [TEAE; headache, 14 of 36 Rozanolixizumab pharmacokinetics demonstrated nonlinear increases with dose. These data provide clinical evidence for the therapeutic potential of rozanolixizumab. No claim to original U. Government Works.This website uses a limited number of cookies to improve your browsing experience.

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Top of this page Skip navigation, go straight to the content. UCB is connecting science in new ways to illuminate the biological pathways involved in severe diseases. Information provided on this pages represents molecules currently under investigation and are not approved by any health authority worldwide. Notice about cookies This website uses a limited number of cookies to improve your browsing experience.

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Responsibility U. News Media Contact Speaker Requests. Contact Contact Us Healthcare Professionals. Careers Contact us. All rights reserved. Home UCB in the U. Leadership Team Patients Patients U. Clinical Trials Innovation Products U. Innovation Pipeline Responsibility U. Products U.UCB Pharma. The Royal Decree entered into force retroactively as of 1 March and allows for exceptional measures to be taken with respect to general meetings which have been or must be convened before 3 May UCB, as a patient centric company, considers the health of its shareholders, employees, and the public of paramount importance.

UCB also intends to strictly follow the measures and regulations adopted by the Belgian government and other public authorities in the context of the Covid pandemic. UCB considers that it is not able to organize a physical "in-person" meeting without putting in danger the health of its participants or without contamination risk. The General Meeting will therefore be held behind closed doors.

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For more information around the measures UCB is taking, please visit our website's Covid page. UCB, Brussels, Belgium www. With 7 people in approximately 40 countries, the company generated revenue of EUR 4. Printable version PDF version. More stories: UCB Pharma.

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