Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With an Open-label Extension to Evaluate Telitacicept in Generalized Myasthenia Gravis
Led by Vor Biopharma · Updated on 2026-05-07
180
Participants Needed
105
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of telitacicept, a biological treatment, for generalized myasthenia gravis (gMG), an autoimmune disease that causes muscle weakness worsening with activity. This Phase 3 trial addresses the challenge of limited effective therapies for gMG by studying telitacicept, which blocks key proteins involved in B-cell activation that contribute to autoimmune symptoms. The study is randomized, double-blind, and placebo-controlled and includes an open-label extension for longer-term assessment. Participants will receive either telitacicept or a placebo through subcutaneous injections during the 24-week double-blind treatment period. After this, they may join a 48-week open-label extension where all participants can receive telitacicept, followed by an extended variable period until the drug is approved or further development concludes. The study includes an 8-week safety follow-up at the end. Throughout the trial, participants will undergo evaluations including muscle weakness scores such as the Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) assessments. Quality of life and symptom improvement will also be measured. Safety monitoring and continued clinical assessments will occur during treatment, the extension, and follow-up periods, with total participation length varying based on extension continuation.
CONDITIONS
Brief Title
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older at screening
- Confirmed diagnosis of generalized myasthenia gravis with clinical muscle weakness classified as MGFA II-IV
- Positive antibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at screening
- MG-ADL score of 6 points or higher with ocular-related score less than 50% of total at screening and baseline
- QMG score of 8 points or higher with at least 4 items scoring 2 points or more at screening and baseline
You will not qualify if you...
- Diagnosis of other autoimmune diseases that could affect safety or study results
- Presence of acute or chronic infections
- Thymoma diagnosed within 5 years or thymectomy surgery within 6 months prior to screening
- History or current primary immunodeficiency
- History of cancer within the last 5 years
- Serious diseases affecting heart, liver, kidneys, lungs, endocrine system, or blood
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either telitacicept or placebo by subcutaneous injection during the double-blind treatment period.
Weekly visits for up to 24 weeks
Duration - 48 weeks
Participants who complete the double-blind period may continue to receive telitacicept in an open-label extension.
Regular visits during the open-label extension
Duration - Variable duration
Participants may continue telitacicept treatment during an extended open-label extension until the drug is approved or development concludes in their country.
Visit schedule varies during the extended open-label extension
Duration - 8 weeks
Participants are followed for 8 weeks after ending treatment to monitor safety and health status.
1 to 2 visits during the follow-up period
Trial Site Locations
Total: 105 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
3
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143
Actively Recruiting
4
SFM Clinical Research
Boca Raton, Florida, United States, 33487
Actively Recruiting
5
Allied Biomedical Research Institute (ABRI)
Miami, Florida, United States, 33155
Actively Recruiting
6
Medsol Clinical Research Center
Port Charlotte, Florida, United States, 33952
Actively Recruiting
7
University of South Florida Health (USF Health)
Tampa, Florida, United States, 33613
Actively Recruiting
8
Wellstar MCG Health Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
9
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
10
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
11
University of Louisville Physicians
Louisville, Kentucky, United States, 40202
Actively Recruiting
12
Neurology Center of New England
Foxborough, Massachusetts, United States, 02035
Actively Recruiting
13
Michigan State University Clinical Center
East Lansing, Michigan, United States, 48824
Actively Recruiting
14
Trinity Health - Grand Rapids Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
15
Mount Sinai Health System
New York, New York, United States, 10029
Actively Recruiting
16
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
17
University of Cincinnati Health Physicians - Clifton
Cincinnati, Ohio, United States, 45219
Actively Recruiting
18
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
19
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
Actively Recruiting
20
Center for Neurological Disorders, S.C. - Greenfield - Gamma Therapeutic Center
Greenfield, Wisconsin, United States, 53228
Actively Recruiting
21
STAT Research S.A.
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1023AAB
Actively Recruiting
22
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
Actively Recruiting
23
Hospital General de Agudos José María Ramos Mejía
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1221ADC
Actively Recruiting
24
Fundación Scherbovsky
Mendoza, Mendoza Province, Argentina, M5500AXR
Actively Recruiting
25
INECO Neurociencias Oroño
Rosario, Santa Fe Province, Argentina, S2000TP
Actively Recruiting
26
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Actively Recruiting
27
Townsville University Hospital
Douglas, Queensland, Australia, 4814
Actively Recruiting
28
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
29
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
30
Centre Hospitalier Régional de la Citadelle
Liège, Liège, Belgium, 4000
Actively Recruiting
31
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil, 81210-310
Actively Recruiting
32
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil, 90619-900
Actively Recruiting
33
Universidade Estadual de Campinas
Campinas, São Paulo, Brazil, 13083-888
Actively Recruiting
34
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14051-140
Actively Recruiting
35
Pseg Centro de Pesquisa Clinica
São Paulo, São Paulo, Brazil, 04038-002
Actively Recruiting
36
University Hospital - London Health Sciences Centre
London, Ontario, Canada, N6C 2R5
Actively Recruiting
37
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Not Yet Recruiting
38
AnHui Provincial Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
39
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
40
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Actively Recruiting
41
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
42
The Second Hospital & Clinical Medical School. Lan Zhou University
Lanzhou, Gansu, China, 730000
Actively Recruiting
43
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
44
Affiliated Hospital of ZunYi Medical University
Zunyi, Guizhou, China, 563000
Actively Recruiting
45
TongJi Medical College of HUST
Wuhan, Hubei, China, 430030
Actively Recruiting
46
XiangYa Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
47
Jilin University China-Japan Union Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
48
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, Shaanxi, China, 710000
Actively Recruiting
49
Xi'An GaoXin Hospital
Xi'an, Shaanxi, China, 710000
Actively Recruiting
50
QiLU Hospital of ShanDong University
Jinan, Shangdong, China, 250000
Actively Recruiting
51
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shangdong, China, 250031
Actively Recruiting
52
The First People's Hospital of JiNing Medical University
Jining, Shangdong, China, 272000
Actively Recruiting
53
Huashan Hospital of the ShangHai FuDan University Medical College
Shanghai, Shanghai Municipality, China, 201100
Actively Recruiting
54
First Hospital of ShanXi Medical University
Taiyuan, Shanxi, China, 030000
Actively Recruiting
55
NingBo Medical Center LiHuiLi Hospital
Ningbo, Zhejiang, China, 315100
Actively Recruiting
56
The 1 School of Medicine, School of Information and Engineering. The 1 Affiliated Hospital of WMU.
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
57
Fakultni Nemocnice Ostrava
Ostrava-Poruba, Moravian-Silesian, Czechia, 708 54
Actively Recruiting
58
MINKSneuro s.r.o. - MUDr. Eduard Minks Ph.D.
Brno, South Moravian, Czechia, 603 00
Actively Recruiting
59
Fakultni Nemocnice Brno
Brno, South Moravian, Czechia, 625 00
Actively Recruiting
60
Hôpital Pasteur
Nice, Alpes-Maritimes, France, 06001
Actively Recruiting
61
Groupe Hospitalier Pellegrin
Bordeaux, Gironde, France, 33076
Actively Recruiting
62
Multi-profile Clinic "New Hospitals"
Tbilisi, Georgia, 0114
Actively Recruiting
63
Pineo Medical Ecosystem
Tbilisi, Georgia, 0114
Actively Recruiting
64
Aversi Clinic - Central Branch
Tbilisi, Georgia, 0160
Actively Recruiting
65
Simon Khechinashvili University Hospital
Tbilisi, Georgia, 0179
Actively Recruiting
66
IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
San Giovanni Rotondo, Foggia, Italy, 71013
Actively Recruiting
67
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, Napoli, Italy, 80131
Actively Recruiting
68
Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
Naples, Napoli, Italy, 80131
Actively Recruiting
69
Azienda Ospedaliera Universitaria Federico II
Naples, Napoli, Italy, 80131
Actively Recruiting
70
Fondazione Istituto San Raffaele - G. Giglio Di Cefalu
Cefalù, Palermo, Italy, 90015
Actively Recruiting
71
Istituto Neurologico Casimiro Mondino
Pavia, Pavia, Italy, 27100
Actively Recruiting
72
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Rome, Italy, 00168
Actively Recruiting
73
Azienda Ospedaliera - Universitaria Sant' Andrea
Rome, Rome, Italy, 00189
Actively Recruiting
74
National Hospital Organization - Nagoya Medical Center
Nagoya, Aichi-ken, Japan, 460-0001
Actively Recruiting
75
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
76
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan, 060-8543
Actively Recruiting
77
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
78
Kobe University Hospital
Kobe, Hyōgo, Japan, 650-0017
Actively Recruiting
79
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan, 216-8511
Actively Recruiting
80
Yokohama Medical Center
Yokohama, Kanagawa, Japan, 245-8575
Actively Recruiting
81
National Hospital Organization Utano National Hospital
Kyoto, Kyoto, Japan, 616-8255
Actively Recruiting
82
NHO Sendai Medical Center
Sendai, Miyagi, Japan, 983-8520
Actively Recruiting
83
National Hospital Organization Niigata National Hospital
Kashiwazaki-Shi, Niigata, Japan, 945-8585
Actively Recruiting
84
Okinawa National Hospital
Ginowan-Shi, Okinawa, Japan, 901-2214
Actively Recruiting
85
Nagoya City University Hospital
Suita-shi, Osaka, Japan, 564-0013
Actively Recruiting
86
Seirei Hamamatsu General Hospital
Hamamatsu, Sizuoka [Shizuoka], Japan, 430-8558
Actively Recruiting
87
Tokushima University Hospital
Tokushima, Tokusima [Tokushima], Japan, 770-8503
Actively Recruiting
88
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
89
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Actively Recruiting
90
Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD
Poznan, Greater Poland Voivodeship, Poland, 61-853
Actively Recruiting
91
Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-065
Actively Recruiting
92
Neurocentrum Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
Actively Recruiting
93
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland, 31-505
Actively Recruiting
94
Clinirem - Lublin
Lublin, Lublin Voivodeship, Poland, 20-064
Actively Recruiting
95
Centrum Medyczne Hope Clinic
Lublin, Lubusz Voivodeship, Poland, 20-701
Actively Recruiting
96
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, Lubusz Voivodeship, Poland, 67-100
Actively Recruiting
97
Centrum Medyczne Neuroprot
Warsaw, Masovian Voivodeship, Poland, 01-684
Actively Recruiting
98
MTZ Powered by Pratia
Warsaw, Masovian Voivodeship, Poland, 02-172
Actively Recruiting
99
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
100
Neurologia Śląska Centrum Medyczne
Katowice, Silesian Voivodeship, Poland, 40-123
Actively Recruiting
101
Hospital General Universitario Dr. Balmis
Alicante, Alicante, Spain, 03010
Actively Recruiting
102
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
103
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, Spain, 08221
Actively Recruiting
104
Hospital Universitario de Basurto
Bilbao, Biscay, Spain, 48013
Actively Recruiting
105
Hospital Universitari i Politècnic La Fe
Valencia, València, Spain, 46026
Actively Recruiting
Research Team
J
Jeremy Sokolove
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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