Clinical Trials in Australia / NCT06456580
Recruiting
Phase 3
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
NCT06456580 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Generalized Myasthenia Gravis
Investigational drug(s) / intervention(s)
Telitacicept →Placebo
Telitacicept: Subcutaneous injection
Placebo: Subcutaneous injection
Study summary
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
Eligibility
Key Inclusion Criteria:
1. Male or female patient aged ≥18 years at screening.
2. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV.
3. Patients have positive antibodies against AChR or MuSK at screening.
4. MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score.
5. QMG score ≥8 points, and ≥ 4 items score at least 2 points at screening and baseline.
Key Exclusion Criteria:
1. Patients have been diagnosed with any other autoimmune disease which can potentially pose a safety or efficacy confounding risk.
2. Patients having acute or chronic infection.
3. Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening. Patients with thymoma diagnosed 3-5 years prior to screening may be eligible if thymoma was at a localized stage and definitively treated with complete surgical resection.
4. Patients having current or history of primary immunodeficiency.
5. Patients having history of malignancy within the last 5 years.
6. Patient having prior or continuing diagnosis of serious cardiovascular, liver, kidney, respiratory system, endocrine or hematologic disease.
Primary outcome measure(s)
- Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Week 24 — Week 24
The MG-ADL is an 8-item patient-reported outcome measure assessing MG symptoms and their effects on daily activities. Each item in the scale is scored on a 0 to 3 (0=normal, 3=severe disease) point scale. The total score is the sum of all individual item scores ranging from 0 to 24. Higher scores indicate more severe disability due to MG. A decrease from Baseline score indicates improvement.
Trial sites (111)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth Neurology - Bob Bové Neuroscience Institute | Scottsdale | Arizona | Recruiting |
| University of Southern California | Los Angeles | California | Recruiting |
| University of California Irvine | Orange | California | Recruiting |
| University of California San Francisco (UCSF) | San Francisco | California | Recruiting |
| SFM Clinical Research | Boca Raton | Florida | Recruiting |
| Allied Biomedical Research Institute (ABRI) | Miami | Florida | Recruiting |
| Medsol Clinical Research Center | Port Charlotte | Florida | Recruiting |
| University of South Florida Health (USF Health) | Tampa | Florida | Recruiting |
| Wellstar MCG Health Medical Center | Augusta | Georgia | Recruiting |
| Hospital Sisters Health System Medical | O'Fallon | Illinois | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| University of Kentucky | Lexington | Kentucky | Recruiting |
| University of Louisville Physicians | Louisville | Kentucky | Recruiting |
| Neurology Center of New England | Foxborough | Massachusetts | Recruiting |
| Michigan State University Clinical Center | East Lansing | Michigan | Recruiting |
| Trinity Health - Grand Rapids Hospital | Grand Rapids | Michigan | Recruiting |
| UM Health Care - Neurology and Sleep Disorders Clinic | Columbia | Missouri | Recruiting |
| Hospital for Special Surgery | New York | New York | Recruiting |
| Mount Sinai Health System | New York | New York | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| University of North Carolina Hospitals - Neurology Clinic | Chapel Hill | North Carolina | Recruiting |
| University of Cincinnati Health Physicians - Clifton | Cincinnati | Ohio | Recruiting |
| Empower Clinical Research | Tigard | Oregon | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| Houston Methodist Neurological Institute | Houston | Texas | Recruiting |
| Center for Neurological Disorders, S.C. - Greenfield - Gamma Therapeutic Center | Greenfield | Wisconsin | Recruiting |
| STAT Research S.A. | Ciudad Autónoma de Buenos Aires | Buenos Aires | Recruiting |
| Hospital Italiano de Buenos Aires | Ciudad Autónoma de Buenos Aires | Buenos Aires | Recruiting |
| Hospital General de Agudos José María Ramos Mejía | Ciudad Autónoma de Buenos Aires | Buenos Aires | Recruiting |
| Fundación Scherbovsky | Mendoza | Mendoza Province | Recruiting |
| INECO Neurociencias Oroño | Rosario | Santa Fe Province | Recruiting |
| Concord Repatriation General Hospital | Concord | New South Wales | Recruiting |
| Townsville University Hospital | Douglas | Queensland | Recruiting |
| Gold Coast University Hospital | Southport | Queensland | Recruiting |
| Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg | Leuven | Flemish Brabant | Recruiting |
| Centre Hospitalier Régional de la Citadelle | Liège | Liège | Recruiting |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | Recruiting |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | Recruiting |
| Universidade Estadual de Campinas | Campinas | São Paulo | Recruiting |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto | São Paulo | Recruiting |
+ 71 more sites — see the full list on the official registry below.
Other trials for the same condition
A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06456580 on ClinicalTrials.gov ↗ ← All trials in Australia