A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
- Registration Number
- NCT04951622
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).
- Detailed Description
Myasthenia gravis (MG) is a rare, heterogeneous, neuromuscular disease characterized by fluctuating, fatigable muscle weakness. MG is caused by pathogenic autoantibodies that impair cholinergic transmission in the postsynaptic membrane at the neuromuscular junction and impair or prevent muscle contraction. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human, aglycosylated immunoglobulin (Ig)G1 monoclonal antibody (mAb) designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal Fc receptor (FcRn). This study will consist of a screening phase (up to 4 weeks), treatment phase (a 24-week double-blind placebo-controlled phase, and an open-label extension \[OLE\] phase \[up to 2 years\]) and a follow-up safety visit (up to 8 weeks after last infusion of study intervention). Efficacy evaluations will include assessments such as Myasthenia Gravis - Activities of Daily Living (MG-ADL) score. Safety evaluations (such as adverse events, physical examination, vital signs, electrocardiogram \[ECG\], and clinical laboratory tests) will be performed. The overall duration of study will be up to 4 years and 8 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 198
- Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening
- Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 6 at screening and baseline
- Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
- Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
- Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase. Nipocalimab Nipocalimab Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase. Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion till study end.
- Primary Outcome Measures
Name Time Method Average Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Baseline up to Week 24 Average change from baseline in MG-ADL score over Weeks 22, 23 and 24 of the double-blind placebo-controlled phase will be reported. Averaging over multiple time points (Weeks 22, 23 and 24) will be done to get a single measure. The MG-ADL provides a rapid assessment of the participant's MG symptom severity. Eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) are rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score will be sum of eight function scores and can range from 0 to 24. A higher score indicates greater symptom severity.
- Secondary Outcome Measures
Name Time Method Average Change in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24 of the Double-blind Placebo-controlled Phase Up to Weeks 22 and 24 Average change in QMG score over Weeks 22 and 24 of the double-blind placebo-controlled phase will be reported. The QMG test is a standardized quantitative strength assessment comprising 13 components. The quantitative results of each strength component are mapped to the following 4-point scale: 0 equals to (=) none, 1 = mild, 2 = moderate and 3 = severe. The total score will be sum of 13 components scores and can range from 0 to 39. A higher score indicates greater weakness.
Percentage of Participants with Improvement in MG-ADL Total Score Greater Than Or Equal to (>=) 2 Points at Week 1 and/or Week 2 of the Double-blind Placebo-controlled Phase Weeks 1 and 2 Percentage of participants with improvement in MG-ADL total score \>= 2 points at Week 1 and/or Week 2 of the double-blind placebo-controlled phase will be reported.
Percentage of Participants with Adverse Events (AEs) Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Change from Baseline in the Visual Analog Scale (VAS) Score of European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks of the Double-blind Placebo-controlled Phase Baseline up to 24 weeks Change from baseline in the VAS score of EQ-5D-5L scale over 24 weeks of the double-blind placebo-controlled phase will be reported. EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). Positive change in score indicates improvement.
Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs]) Up to 4 years and 8 months Number of participants with antibodies to nipocalimab (ADAs and NAbs) will be reported.
Percentage of Participants with Serious Adverse Events (SAEs) Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Percentage of Participants with Adverse Events of Special Interest (AESIs) Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) Percentage of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered as AESI: 1) severe or medically significant or immediately life-threatening infections requiring intravenous (IV) anti-infective or operative/invasive intervention or requiring hospitalization or prolongation of existing hospitalization; 2) hypoalbuminemia with albumin less than (\<) 20 grams per liter (g/L). Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Percentage of Participants with Change in Clinical Laboratory Values Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) Percentage of participants with change in clinical laboratory (serum chemistry, hematology, lipid profiles and urinalysis) values will be reported.
Average Change from Baseline in the Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-Qol15r) Score Over Weeks 22 And 24 of the Double-blind Placebo-controlled Phase Baseline up to Weeks 22 and 24 Average change from baseline in the MG-QoL15r score over Weeks 22 and 24 of the double-blind placebo-controlled phase will be reported. The MG-QoL15r is a participant-reported outcome instrument that measures MG-specific health-related quality of life. The MG-QoL15r contains 15 items that evaluate patients' experience related to Myasthenia Gravis over the "past few weeks" on a 3-point Likert-type scale (0=Not at all; 1=Somewhat; 2=Very much). The total score of the MG-QoL15r can be calculated by summing 15 items score and can range from 0 to 30. A higher score indicates poorer health related quality of life.
Serum Nipocalimab Concentrations Over Time Up to 4 years and 8 months Serum nipocalimab concentrations over time will be reported.
Change from Baseline in MG-ADL Score as a Function of IgG Baseline up to 4 years and 8 months Change from baseline in MG-ADL score as a function of IgG will be reported.
Change from Baseline in QMG Score as a Function of IgG Baseline up to 4 years and 8 months Change from baseline in QMG score as a function of IgG will be reported.
Change From Baseline in QMG Score as a Response to Percent Change in Autoantibody Levels, in Seropositive Participants Treated with Nipocalimab Baseline up to 4 years and 8 months Change from baseline in QMG score as a response to percent change in autoantibody levels, in seropositive participants (anti-AChR, anti-MuSK, anti-LRP4) treated with nipocalimab will be reported.
Percentage of Participants whose Average MG-ADL Total Score Over Weeks 22, 23, and 24 is at least a 2-Point Improvement from Baseline of the Double-blind Placebo-controlled Phase Baseline up to Weeks 22, 23 and 24 Percentage of participants whose average MG-ADL total score over Weeks 22, 23, and 24 is at least a 2-point improvement from baseline of the double-blind placebo-controlled phase will be reported.
Percentage of Participants with Improvement in MG-ADL Total Score >= 2 Points at Week 4 through Week 24 of the Double-blind Placebo-controlled Phase with No More Than 2 Non-consecutive Excursions Allowed Between Weeks 6 through Week 23 Week 4 up to Week 24 Percentage of participants with improvement in MG-ADL total score \>= 2 points at Week 4 through Week 24 of the double-blind placebo-controlled phase with no more than 2 non-consecutive excursions allowed between Weeks 6 through Week 23 (excursion is defined as loss of improvement in MG-ADL score \>= 2 points from baseline) will be reported.
Percentage of Participants whose Average Improvement in MG-ADL Total Score Over Weeks 22, 23, and 24 of the Double-blind, Placebo-controlled Phase is at Least a 50% Improvement from Baseline Baseline, Weeks 22, 23 and 24 Percentage of participants whose average improvement in MG-ADL total score over Weeks 22, 23, and 24 of the double-blind, placebo-controlled phase is at least a 50% improvement from baseline will be reported.
Percentage of Participants with Change in Vital Signs Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) Percentage of participants with change in vital signs (temperature, blood pressure and heart rate) will be reported.
Percentage of Participants with Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) Percentage of participants with change in C-SSRS scale score will be reported. C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. Total score ranges from 1 to 10. Higher scores indicate greater severity.
Percentage of Participants with MG-ADL Score of 0 or 1 at 50% of Timepoints During the Double-blind, Placebo-controlled Phase Up to Week 24 Percentage of participants with MG-ADL score of 0 or 1 at 50% of timepoints during the double-blind, placebo-controlled phase will be reported.
Percentage of Participants with MG-ADL Score of 0 or 1 at 75% of Timepoints During the Double-blind, Placebo-controlled Phase Up to Week 24 Percentage of participants with MG-ADL score of 0 or 1 at 75% of timepoints during the double-blind, placebo-controlled phase will be reported.
Change in Levels of Autoantibodies Associated with Generalized Myasthenia Gravis (gMG) Up to 4 years and 8 months Change in levels of autoantibodies associated with gMG will be reported.
Percentage of Participants with Improvement in QMG Score of >= 3 Points from Baseline at Week 2 through Week 24 of the Double-blind Placebo-controlled Phase with No More than 2 Non-consecutive Excursions Allowed at Weeks 4 through 22 Week 2 up to Week 24 Percentage of participants with improvement in QMG score of \>= 3 points from baseline at Week 2 through Week 24 of the double-blind placebo-controlled phase with no more than 2 non-consecutive excursions allowed at weeks 4 through 22 (excursions defined as loss of improvement in QMG score of \>= 3 points from baseline) will be reported.
Average Change From Baseline in the Fatigue Items of the Quality of Life in Neurological Disorders Scale (Neuro-QoL Fatigue) Total Score Over Weeks 22 and 24 of Double-blind Placebo-controlled Phase Baseline up to Weeks 22 and 24 Average change from baseline in the Neuro-QoL Fatigue total score over Weeks 22 and 24 of double-blind placebo-controlled phase will be reported. Neuro-QoL fatigue is a 19-item questionnaire developed and validated for use in common neurological conditions which assesses patient-reported fatigue and associated impact on physical, mental, and social activities during the past 7 days. Each item included in the Neuro-QoL Fatigue questionnaire is graded on a 5-point Likert-type scale (1=Never; 2=Rarely; 3=Sometimes; 4=Often; 5=Always). The total scores are calculated by summing 19 items score and can range from 19-95. Higher score reflects more fatigue.
Change in Total Serum Immunoglobulin G (IgG) Concentrations Up to 4 years and 8 months Change in total serum IgG concentrations will be reported.
Change from Baseline in the Health Status Index of the EQ-5D-5L Scale Over 24 Weeks of the Double-blind Placebo-controlled Phase Baseline up to 24 weeks Change from baseline in health status index of EQ-5D-5L scale over 24 weeks of double-blind placebo-controlled phase will be reported. EQ-5D-5L is standardized instrument for use as measure of health outcome, primarily designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ-VAS. EQ-5D-5L descriptive system comprises following 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of 5 dimensions is divided into 5 levels of perceived problems (1 indicating no problem, 2 indicating slight problems, 3 indicating moderate problems, 4 indicating severe problems, 5 indicating extreme problems). Participant selects an answer for each of 5 dimensions considering response that best matches his or her health "today". The responses to 5 dimensions are used to compute a single score ranging from zero (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual.
Percentage of Participants with MG-ADL Score of 0 or 1 Over Time in the Double-blind, Placebo-controlled Phase Up to Week 24 Percentage of participants with MG-ADL score of 0 or 1 over time in the double-blind, placebo-controlled phase will be reported.
Percentage of Participants with MG-ADL Score of 0 or 1 at Any Time During the Double-blind, Placebo-controlled Phase Up to Week 24 Percentage of participants with MG-ADL score of 0 or 1 at any time during the double-blind, placebo-controlled phase will be reported.
Change From Baseline in MG-ADL Score as a Response to Percent Change in Autoantibody Levels, in Seropositive Participants Treated with Nipocalimab Baseline up to 4 years and 8 months Change from baseline in MG-ADL as a response to percent change in autoantibody levels, in seropositive participants (anti-acetylcholine receptor \[anti-AChR\], anti-muscle-specific kinase \[anti-MuSK\], anti-lipoprotein-related protein receptor 4 \[anti-LRP4\]) treated with nipocalimab will be reported.
Trial Locations
- Locations (111)
Istituto Neurologico Carlo Besta
🇮🇹Milano, Italy
Hosp. Univ. I Politecni La Fe
🇪🇸Valencia, Spain
Karlstad Central Hospital
🇸🇪Karlstad, Sweden
U.O.P.I. di Psichiatria
🇮🇹Catania, Italy
Hosp. Virgen Macarena
🇪🇸Sevilla, Spain
Hosp. Virgen Del Rocio
🇪🇸Sevilla, Spain
Fondazione Istituto G. Giglio
🇮🇹Cefalu, Italy
Neuromuscular Research Center and Clinic
🇺🇸Paradise Valley, Arizona, United States
HonorHealth Neurology
🇺🇸Scottsdale, Arizona, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Care Access Research
🇺🇸Pasadena, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
🇺🇸Boca Raton, Florida, United States
University of Florida Health Jacksonville
🇺🇸Jacksonville, Florida, United States
Medsol Clinical Research Center Inc
🇺🇸Port Charlotte, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
St. Elizabeth Medical Center
🇺🇸Boston, Massachusetts, United States
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States
Duke University School of Medicine
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
St Marianna University Hospital
🇯🇵Kawasaki Shi, Japan
The Ohio State University
🇺🇸Columbus, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Wesley Neurology
🇺🇸Cordova, Tennessee, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Melbourne Neurology Group
🇦🇺North Melbourne, Australia
Gold Coast University Hospital
🇦🇺Southport, Australia
ULB Hôpital Erasme
🇧🇪Anderlecht, Belgium
AZ Sint Jan Brugge Oostende AV
🇧🇪Brugge, Belgium
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
AZ Sint-Lucas
🇧🇪Gent, Belgium
University Hospitals Leuven
🇧🇪Leuven, Belgium
The Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie
🇩🇪Wiesbaden, Germany
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, China
Xuanwu Hospital ,Capital Medical University
🇨🇳Beijing, China
Beijing Hospital
🇨🇳Beijing, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, China
Xiangya Hospital Central South University
🇨🇳Changsha, China
West China Hospital of Sichuan University
🇨🇳Chengdu, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
🇨🇳Guangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Qianfoshan hospital of Shandong Province
🇨🇳Jinan, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China
Huashan Hospital Fudan University
🇨🇳Shanghai, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
🇨🇳Xi'An, China
Neurologie a rehabilitace Skopalíkova
🇨🇿Brno, Czechia
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Vseobecna Fakultní Nemocnice
🇨🇿Praha, Czechia
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Rigshospitalet
🇩🇰København Ø, Denmark
Hopital Pierre Wertheimer
🇫🇷Bron, France
CHU Grenoble
🇫🇷Grenoble, France
Hopital de la Pitie Salpetriere
🇫🇷Paris, France
Hopital PASTEUR
🇫🇷Provence-Alpes-Côte d'Azur, France
NeuroCure Clinical Research Center
🇩🇪Berlin, Germany
Universitatsmedizin Gottingen
🇩🇪Göttingen, Germany
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck
🇩🇪Lübeck, Germany
Universitatsklinikum Ulm
🇩🇪Ulm, Germany
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
🇮🇹Napoli, Italy
IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
🇮🇹Pavia, Italy
Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
🇮🇹Roma, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
Chiba University Hospital
🇯🇵Chiba, Japan
General Hanamaki Hospital
🇯🇵Hanamaki, Japan
Hiroshima University Hospital
🇯🇵Hiroshima shi, Japan
Teikyo University Hospital
🇯🇵Itabashi Ku, Japan
Kagawa University Hospital
🇯🇵Kita Gun, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Iwate Medical University Hospital
🇯🇵Morioka-shi, Japan
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya-shi, Japan
Niigata City General Hospital
🇯🇵Niigata, Japan
Hyogo College of Medicine Hospital
🇯🇵Nishinomiya-Shi, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Japan
Hokkaido Medical Center
🇯🇵Sapporo, Japan
National Hospital Organization Sendai Medical Center
🇯🇵Sendai-City, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan
Tokyo Medical University Hospital
🇯🇵Tokyo, Japan
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
iBiomed Research Unit
🇲🇽Aguascalientes, Mexico
Consultorio Dr. Miguel Cortes
🇲🇽Cuernavaca, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
🇲🇽Guadalajara, Mexico
Neurocentrum Bydgoszcz Sp Z O O
🇵🇱Bydgoszcz, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
🇵🇱Katowice, Poland
Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
🇵🇱Krakow, Poland
Prywatny Gabinet Lekarski
🇵🇱Lublin, Poland
Centrum Medyczne NeuroProtect
🇵🇱Warsaw, Poland
Hosp. Gral. Univ. de Alicante
🇪🇸Alicante, Spain
Hosp. de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Hosp. Univ. de Basurto
🇪🇸Bilbao, Spain
Karolinska Universitetssjukhuset Solna
🇸🇪Stockholm, Sweden
China Medical University Hospital
🇨🇳Taichung, Taiwan
Shin Kong Wu Ho Su Memorial Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan