A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis
A legfontosabb adatok
- Hol
- Aurora, Austin, Baltimore, Boston, Chicago, Cleveland, Columbus, Dallas, Durham, Henrico, Hershey, Houston, Irvine, Jacksonville, Kansas City, Los Angeles, Milwaukee, New Haven, New York, Omaha, Palo Alto, Philadelphia, Phoenix, Pittsburgh, Portland, Rochester, San Francisco, Seattle, St Louis és Winston-Salem (Egyesült Államok)Mind a 34 helyszín megnézése
- Fázis
- 2/3. fázis
Helyszínek itt: Egyesült Államok
- University of Colorado Hospital Anschutz Outpatient PavillionAurora, Egyesült ÁllamokNo longer taking part
- Austin Neuromuscular CenterAustin, Egyesült ÁllamokNo longer taking part
- Johns Hopkins Bayview Medical CenterBaltimore, Egyesült ÁllamokNo longer taking part
- Johns Hopkins University School Of MedicineBaltimore, Egyesült ÁllamokNo longer taking part
- Brigham and Womens HospitalBoston, Egyesült ÁllamokNo longer taking part
- Neuromuscular Diagnostic Center - Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
- Northwestern Memorial Hospital, Department of Neurology (Clinic)Chicago, Egyesült ÁllamokNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, Egyesült ÁllamokNo longer taking part
- The Ohio State University -Wexner Medical CenterColumbus, Egyesült ÁllamokNo longer taking part
- Texas NeurologyDallas, Egyesült ÁllamokNo longer taking part
- Duke Neurological Disorders Clinic -1LDurham, Egyesült ÁllamokNo longer taking part
- Virginia Commonwealth UniversityHenrico, Egyesült ÁllamokNo longer taking part
- Penn State Health Milton S. Hershey Medical CenterHershey, Egyesült ÁllamokNo longer taking part
- Nerve and Muscle Center of TexasHouston, Egyesült ÁllamokNo longer taking part
- University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular CenterIrvine, Egyesült ÁllamokNo longer taking part
- Mayo ClinicJacksonville, Egyesült ÁllamokNo longer taking part
- University of Kansas MedicalKansas City, Egyesült ÁllamokNo longer taking part
- Keck Hosptial of USCLos Angeles, Egyesült ÁllamokNo longer taking part
- UCLA Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- Medical College of WisconsinMilwaukee, Egyesült ÁllamokNo longer taking part
- Yale School of MedicineNew Haven, Egyesült ÁllamokNo longer taking part
- Columbia University Medical Center The Neurological Institute of New YorkNew York, Egyesült ÁllamokNo longer taking part
- Hospital for Special SurgeryNew York, Egyesült ÁllamokNo longer taking part
- University of Nebraska Medical CenterOmaha, Egyesült ÁllamokNo longer taking part
- Stanford Neuroscience Medical CenterPalo Alto, Egyesült ÁllamokNo longer taking part
- University of PennsylvaniaPhiladelphia, Egyesült ÁllamokNo longer taking part
- Neuromuscular Research CenterPhoenix, Egyesült ÁllamokNo longer taking part
- UPMC Arthritis and Autoimmunity Center, Falk ClinicPittsburgh, Egyesült ÁllamokNo longer taking part
- Oregon Health Science UniversityPortland, Egyesült ÁllamokNo longer taking part
- Mayo ClinicRochester, Egyesült ÁllamokNo longer taking part
- University of California San FranciscoSan Francisco, Egyesült ÁllamokNo longer taking part
- University of Washington Medical Center - MontlakeSeattle, Egyesült ÁllamokNo longer taking part
- Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
- Wake Forrest School of MedicineWinston-Salem, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Abcuro, Inc.
- Azonosító
- NCT05721573
- A regiszteradat frissítve
- 2026. október 1.
- Eredeti leírás
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body MyositisA teljes eredeti leírásKevesebb
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABC008 in the Treatment of Subjects With Inclusion Body Myositis
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
Bevonási feltételek: Adult males and females age >40 years at the time of the first dose of study medication; Weight >40 and <150 kg; Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM according to the European Neuromuscular Centre (ENMC) IBM 2011 research diagnostic criteria (Rose et al., 2013). Documented histopathology results must be available prior to Baseline (Day 1) to confirm eligibility; Able to arise from a chair (with armrests), with use of their arms but without support from another person or device (e.g., cane, walking stick), at Screening and Baseline (Day 1); Able to walk 3 meters, turn around, walk back to the chair, and sit down, with or without assistive device. Once arisen from the chair, subject may use any walking device but cannot be supported by another person, furniture, or a wall.
Kizáró feltételek: Any other form of myositis or myopathy other than IBM, e.g., metabolic or drug-induced myopathy, drug-induced myositis, anti-synthetase syndrome, polymyositis or dermatomyositis, cancer-associated myositis (myositis diagnosed within 3 years, either before or after), myositis in overlap with another autoimmune disease (e.g., systemic lupus, systemic sclerosis, rheumatoid arthritis), or muscular dystrophy; Any condition, e.g., severe degenerative arthritis with limited range of motion, which precludes the ability to quantitate muscle strength or perform functional assessments (e.g., mTUG), in the Investigator's opinion; Presence of another autoimmune or autoinflammatory disease other than indication under study, e.g., rheumatoid arthritis, psoriatic arthritis, axial spondyloarthropathy, inflammatory bowel disease, systemic lupus erythematosus. Subjects with Sjogren's syndrome, T-cell large granular lymphocyte leukemia (T-LGLL), or well-controlled thyroid disease are permitted.