A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients With Generalized Myasthenia Gravis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients With Generalized Myasthenia Gravis
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
Myasthenia gravis (MG) is an autoimmune disease in which autoantibodies disrupt the postsynaptic membrane, impairing nerve-to-muscle signal transmission. The predominant manifestation is muscle weakness, which typically worsens with repeated muscle exertion, such that function is usually the best in the morning with more pronounced weakness at the end of the day. A major challenge in MG is the lack of therapies that effectively treat the disease.
Telitacicept is a fully human TACI-Fc fusion protein that targets B-lymphocyte stimulator (BLyS) and A proliferating-inducing ligand (APRIL), neutralizing their interactions with receptors on B cells. The blockage of BLyS and APRIL interaction with their respective cell membrane receptors (transmembrane activator and CAML interactor [TACI], B-cell maturation antigen, and BLyS receptors) by telitacicept can inhibit B-cell proliferation and maturation. This suppression at the proximal portion of the immune response could alleviate autoimmune symptoms.
This is a randomized, double-blind, placebo-controlled Phase 3 study with an open-label extension (OLE) to evaluate the efficacy and safety of telitacicept in a global patient population with gMG. The total duration of the study is variable but will include an approximately 4-week screening period, a 24-week double-blind treatment period (Week 0 through Week 24), a 48-week OLE (Week 24 through Week 72), followed by an extended OLE period (E-OLE), and an 8-week end-of-study follow-up period. The E-OLE is variable duration, defined as the period after the 48-week OLE period until telitacicept is approved for MG in the country or the further development in the indication is concluded.
Key Inclusion Criteria:
Key Exclusion Criteria:
Study@vorbio.com617-655-6580
Scottsdale, Arizona 85258, United States
San Francisco, California 94143, United States
Columbia, Missouri 65212, United States
Chapel Hill, North Carolina 27517, United States
Greenfield, Wisconsin 53228, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires C1023AAB, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1199ABB, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1221ADC, Argentina
Leuven, Flemish Brabant 3000, Belgium
Ribeirão Preto, São Paulo 14051-140, Brazil
Chongqing, Chongqing Municipality 400010, China
Lanzhou, Gansu 730000, China
Xi'an, Shaanxi 710000, China
Jinan, Shangdong 250031, China
Shanghai, Shanghai Municipality 201100, China
Wenzhou, Zhejiang 325000, China
Ostrava-Poruba, Moravian-Silesian 708 54, Czechia
San Giovanni Rotondo, Foggia 71013, Italy
Naples, Napoli 80131, Italy
Kashiwazaki-Shi, Niigata 945-8585, Japan
Ginowan-Shi, Okinawa 901-2214, Japan
Suita-shi, Osaka 564-0013, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Shinjuku-ku, Tokyo 160-0023, Japan
Poznan, Greater Poland Voivodeship 61-853, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-065, Poland
Lublin, Lubusz Voivodeship 20-701, Poland
ResearchNCNE@neurocenterne.com781-551-5812 ext. 2