RecruitingPhase 3

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

United States180 participantsStarted 2024-07-17

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patient aged ≥18 years at screening.
✓. 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.
✓. Patients have positive antibodies against AChR or MuSK at screening.
✓. MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score.
✓. QMG score ≥8 points, and ≥ 4 items score at least 2 points at screening and baseline.

✕. Patients have been diagnosed with any other autoimmune disease which can potentially pose a safety or efficacy confounding risk.
✕. Patients having acute or chronic infection.
✕. 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.
✕. Patients having current or history of primary immunodeficiency.
✕. Patients having history of malignancy within the last 5 years.
✕. Patient having prior or continuing diagnosis of serious cardiovascular, liver, kidney, respiratory system, endocrine or hematologic disease.

Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Week 24

Timeframe: Week 24

NCT IDNCT06456580

SponsorVor Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

Jeremy Sokolove

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patient aged ≥18 years at screening.
✓. 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.
✓. Patients have positive antibodies against AChR or MuSK at screening.
✓. MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score.
✓. QMG score ≥8 points, and ≥ 4 items score at least 2 points at screening and baseline.

✕. Patients have been diagnosed with any other autoimmune disease which can potentially pose a safety or efficacy confounding risk.
✕. Patients having acute or chronic infection.
✕. 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.
✕. Patients having current or history of primary immunodeficiency.
✕. Patients having history of malignancy within the last 5 years.
✕. Patient having prior or continuing diagnosis of serious cardiovascular, liver, kidney, respiratory system, endocrine or hematologic disease.