Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
NCT ID: NCT03315130
Last Updated: 2022-07-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2017-10-11
2020-11-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
NCT04115293
An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors
NCT05514873
Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
NCT04225871
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
NCT06055959
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
NCT03920293
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0.1 mg/kg zilucoplan (RA101495)
zilucoplan (RA101495)
Daily subcutaneous (SC) injection
0.3 mg/kg zilucoplan (RA101495)
zilucoplan (RA101495)
Daily subcutaneous (SC) injection
Placebo
Placebo
Daily subcutaneous (SC) injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
zilucoplan (RA101495)
Daily subcutaneous (SC) injection
Placebo
Daily subcutaneous (SC) injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Positive serology for acetylcholine receptor (AChR) autoantibodies
* QMG score ≥ 12 at Screening and Randomization
* No change in corticosteroid dose for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period
* No change in immunosuppressive therapy, including dose, for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period
Exclusion Criteria
* History of meningococcal disease
* Current or recent systemic infection within 2 weeks prior to Randomization or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ra Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diagnostic and Medical Clinic - Mobile
Mobile, Alabama, United States
The Research Center of Southern California
Carlsbad, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of California Irvine Health ALS and Neuromuscular Center
Orange, California, United States
Yale University
New Haven, Connecticut, United States
George Washington University
Washington D.C., District of Columbia, United States
University of Florida
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
University of Buffalo
Buffalo, New York, United States
Hospital for Special Surgery
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, United States
Wesley Neurology Clinic
Cordova, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
Center for Neurological Disorders
Milwaukee, Wisconsin, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
London Health Sciences Centre University Hospital
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Howard JF Jr, Nowak RJ, Wolfe GI, Freimer ML, Vu TH, Hinton JL, Benatar M, Duda PW, MacDougall JE, Farzaneh-Far R, Kaminski HJ; Zilucoplan MG Study Group; Barohn R, Dimachkie M, Pasnoor M, Farmakidis C, Liu T, Colgan S, Benatar MG, Bertorini T, Pillai R, Henegar R, Bromberg M, Gibson S, Janecki T, Freimer M, Elsheikh B, Matisak P, Genge A, Guidon A, David W, Habib AA, Mathew V, Mozaffar T, Hinton JL, Hewitt W, Barnett D, Sullivan P, Ho D, Howard JF Jr, Traub RE, Chopra M, Kaminski HJ, Aly R, Bayat E, Abu-Rub M, Khan S, Lange D, Holzberg S, Khatri B, Lindman E, Olapo T, Sershon LM, Lisak RP, Bernitsas E, Jia K, Malik R, Lewis-Collins TD, Nicolle M, Nowak RJ, Sharma A, Roy B, Nye J, Pulley M, Berger A, Shabbir Y, Sachdev A, Patterson K, Siddiqi Z, Sivak M, Bratton J, Small G, Kohli A, Fetter M, Vu T, Lam L, Harvey B, Wolfe GI, Silvestri N, Patrick K, Zakalik K, Duda PW, MacDougall J, Farzaneh-Far R, Pontius A, Hoarty M. Clinical Effects of the Self-administered Subcutaneous Complement Inhibitor Zilucoplan in Patients With Moderate to Severe Generalized Myasthenia Gravis: Results of a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial. JAMA Neurol. 2020 May 1;77(5):582-592. doi: 10.1001/jamaneurol.2019.5125.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RA101495-02.201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.