NCT06456580 A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
| NCT ID | NCT06456580 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vor Biopharma |
| Condition | Generalized Myasthenia Gravis |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2024-07-17 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06456580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Generalized Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06456580 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT06456580 currently recruiting?
Yes, NCT06456580 is actively recruiting participants. Contact the research team at Study@vorbio.com for enrollment information.
Where is the NCT06456580 trial being conducted?
This trial is being conducted at Los Angeles, United States, Orange, United States, San Francisco, United States, Boca Raton, United States and 11 additional locations.
Who is sponsoring the NCT06456580 clinical trial?
NCT06456580 is sponsored by Vor Biopharma. The trial plans to enroll 180 participants.