Ireland
--:--IST
Active, not recruiting Phase 3

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)

NCT06456580 · tracked via the Priya Life Science Poland tracker
Phase
Phase 3
Started
2024-07-17
Last updated
2026-10-15

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 (120)

FacilityCityRegionStatus
HonorHealth Neurology - Bob Bové Neuroscience Institute Scottsdale Arizona
University of Southern California Los Angeles California
University of California Irvine Orange California
University of California San Francisco (UCSF) San Francisco California
SFM Clinical Research Boca Raton Florida
BayCare Medical Group - Clearwater Clearwater Florida
Allied Biomedical Research Institute (ABRI) Miami Florida
Medsol Clinical Research Center Port Charlotte Florida
University of South Florida Health (USF Health) Tampa Florida
Wellstar MCG Health Medical Center Augusta Georgia
Hospital Sisters Health System Medical O'Fallon Illinois
University of Kansas Medical Center Kansas City Kansas
University of Kentucky Lexington Kentucky
University of Louisville Physicians Louisville Kentucky
Neurology Center of New England Foxborough Massachusetts
Michigan State University Clinical Center East Lansing Michigan
Trinity Health - Grand Rapids Hospital Grand Rapids Michigan
UM Health Care - Neurology and Sleep Disorders Clinic Columbia Missouri
Robert Wood Johnson University Hospital New Brunswick New Brunswick New Jersey
Lange Neurology New York New York
Mount Sinai Health System New York New York
Montefiore Medical Center The Bronx New York
University of North Carolina Hospitals - Neurology Clinic Chapel Hill North Carolina
University of Cincinnati Health Physicians - Clifton Cincinnati Ohio
Empower Clinical Research Tigard Oregon
University of Tennessee Medical Center Knoxville Tennessee
University of Texas Southwestern Medical Center Dallas Texas
Neurology Rare Disease Center Flower Mound Texas
Houston Methodist Neurological Institute Houston Texas
Center for Neurological Disorders, S.C. - Greenfield - Gamma Therapeutic Center Greenfield Wisconsin
STAT Research S.A. Ciudad Autónoma de Buenos Aires Buenos Aires
Hospital Italiano de Buenos Aires Ciudad Autónoma de Buenos Aires Buenos Aires
Hospital General de Agudos José María Ramos Mejía Ciudad Autónoma de Buenos Aires Buenos Aires
INECO Neurociencias Oroño Rosario Santa Fe Province
Fundación Scherbovsky Mendoza Argentina
Concord Repatriation General Hospital Concord New South Wales
Townsville University Hospital Douglas Queensland
Gold Coast University Hospital Southport Queensland
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg Leuven Flemish Brabant
Centre Hospitalier Régional de la Citadelle Liège Belgium

+ 80 more sites — see the full list on the official registry below.

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 Poland