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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Vor Biopharma
Study ID
NCT06456580
Phase
PHASE3
Status
Recruiting

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — BIOLOGICAL
    Subcutaneous injection
  • Placebo — DRUG
    Subcutaneous injection

Study Details

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

Key Dates

First listed
Jun 13, 2024
Start date
Jul 17, 2024
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Jan 31, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept
    Telitacicept
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Week 24 [ Time Frame: Week 24 ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
HonorHealth Neurology - Bob Bové Neuroscience InstituteScottsdaleArizona85258-
University of Southern CaliforniaLos AngelesCalifornia90033-
University of California IrvineOrangeCalifornia92868-
University of California San Francisco (UCSF)San FranciscoCalifornia94143-
SFM Clinical ResearchBoca RatonFlorida33487-
Allied Biomedical Research Institute (ABRI)MiamiFlorida33155-
Medsol Clinical Research CenterPort CharlotteFlorida33952-
University of South Florida Health (USF Health)TampaFlorida33613-
Wellstar MCG Health Medical CenterAugustaGeorgia30912-
Hospital Sisters Health System MedicalO'FallonIllinois62269-
University of Kansas Medical CenterKansas CityKansas66160-
University of KentuckyLexingtonKentucky40506-
University of Louisville PhysiciansLouisvilleKentucky40202-
Neurology Center of New EnglandFoxboroughMassachusetts02035
781-551-5812
Michigan State University Clinical CenterEast LansingMichigan48824-
Trinity Health - Grand Rapids HospitalGrand RapidsMichigan49503-
UM Health Care - Neurology and Sleep Disorders ClinicColumbiaMissouri65212-
Hospital for Special SurgeryNew YorkNew York10021-
Mount Sinai Health SystemNew YorkNew York10029-
Montefiore Medical CenterThe BronxNew York10467-
University of North Carolina Hospitals - Neurology ClinicChapel HillNorth Carolina27517-
University of Cincinnati Health Physicians - CliftonCincinnatiOhio45219-
Empower Clinical ResearchTigardOregon97223-
University of Texas Southwestern Medical CenterDallasTexas75390-
Houston Methodist Neurological InstituteHoustonTexas77030-
Center for Neurological Disorders, S.C. - Greenfield - Gamma Therapeutic CenterGreenfieldWisconsin53228-

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