Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Relapsing Multiple Sclerosis (RMS)
Спонсор: Novartis Pharmaceuticals
Налично на:
БГ
Обобщение
This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.
Описание
This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis
Кой може да участва
Inclusion Criteria:
* Signed informed consent must be obtained prior to participation in the study.
* Male or female study participants aged 18 to 60 years (inclusive) at screening.
* Diagnosis of multiple sclerosis (MS) according to the 2017 Revised McDonald criteria (Thompson et al 2018). Relapsing forms of MS: relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS).
Exclusion Criteria:
* Participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator or emergence of any clinically significant condition/disease (e.g. active systemic bacterial, viral or fungal infections) during screening prior to Day 1 which might result in safety risk for participants.
* Participants with history of confirmed progressive multifocal leukoencephalopathy (PML) or neurological symptoms consistent with PML.
* Participants at risk of developing or having reactivation of hepatitis
* Emergence of active chronic disease (or stable but treated with immune therapy) prior to Day 1 of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency).
* Pregnant or nursing (lactating) women
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma, or squamous cell carcinomas of the skin that have been treated with no evidence of recurrence in the past 3 months).
* Participants taking prohibited therapies, including B cell targeted therapies (e.g. such as ocrelizumab, rituximab, ofatumumab, ublituximab, and inebilizumab)
Other protocol-defined inclusion/exclusion criteria may apply
Интервенции
Ofatumumab approved dose
BIOLOGICAL
Ofatumumab new dose
BIOLOGICAL
Места на провеждане
63
Puerto Rico (2)
Puerto Rico Multiple Sclerosis Ctr
Caguas
Caribbean Center for Clinical Research, Inc
Guaynabo
САЩ (61)
Neuro Medial Clinic of Central Louisiana
Alexandria , Louisiana
Neurology of Central FL Res Ctr
Altamonte Springs , Florida
Sana Research
Arlington , Virginia
Atlanta NeuroScience Institute
Atlanta , Georgia
CU Anschutz Med Campus
Aurora , Colorado
The Research and Education Inst. of Alta Bates Summit Med. Grp
Berkeley , California
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda , Maryland
Alabama Neurology Associates PC
Birmingham , Alabama
Neurology Offices Of South Florida
Boca Raton , Florida
First Choice Neurology
Boca Raton , Florida
Dayton Center for Neurological Disorders
Centerville , Ohio
University Of Cincinnati
Cincinnati , Ohio
OSU Medical Center-Martha Morehouse Medical Plaza
Columbus , Ohio
Neurology Clinic PC
Cordova , Tennessee
Neurology Consultants Of Dallas PA
Dallas , Texas
Henry Ford Hospital
Detroit , Michigan
Fullerton Neuro and Headache Ctr
Fullerton , California
University of Florida
Gainesville , Florida
Hackensack University Medical Ctr
Hackensack , New Jersey
Memorial Healthcare System
Hollywood , Florida
Josephson Wallack Munshower Neurology PC
Indianapolis , Indiana
University of California Irvine
Irvine , California
Univ of Kansas Hosp and Med Ctr
Kansas City , Kansas
University of Tennessee Medical Ctr
Knoxville , Tennessee
Sibyl Wray MD Neurology PC
Knoxville , Tennessee
Cleveland Clinic Foundation
Las Vegas , Nevada
CenExcel Clinical Research
Los Alamitos , California
Velocity Clinical Trials
Los Angeles , California
International Neurorehab Institute
Lutherville , Maryland
Neurology Associates PA
Maitland , Florida
UM Department Of Neurology
Miami , Florida
Elite Clinical Research
Miami , Florida
Medical College of Wisconsin
Milwaukee , Wisconsin
Aqualane Clinical Research
Naples , Florida
Delricht Research
New Orleans , Louisiana
Ochsner Clinic Foundation
New Orleans , Louisiana
AdventHealth
Orlando , Florida
Orlando Health Clinical Trials
Orlando , Florida
Neurology Associates of Ormond Beach
Ormond Beach , Florida
South Shore Neurologic Associates
Patchogue , New York
Thomas Jefferson University Hospital
Philadelphia , Pennsylvania
Xenoscience Inc
Phoenix , Arizona
Ctr for Neurology and Spine
Phoenix , Arizona
Phoenix Neurological Associates
Phoenix , Arizona
Saturn Research Solutions LLC
Plano , Texas
Neurostudies Inc
Port Charlotte , Florida
True North Neurology
Port Jefferson , New York
Velocity Clinical Research
Raleigh , North Carolina
Rochester Cent For Behavioral
Rochester Hills , Michigan
Advent Neurology Clinic
Roeland Park , Kansas
Swedish Neuroscience Institute
Seattle , Washington
WA Uni School Of Med
St Louis , Missouri
MultiCare Research Institute for Research and Innovation
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