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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study with an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients with Generalized Myasthenia Gravis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512126-29-00
Acronym
RC18G006
Enrollment
72
Registered
2024-11-11
Start date
2025-02-25
Completion date
Unknown
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Brief summary

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

Detailed description

• Change from baseline in MG Quality of Life scale (MG-QOL15r) at Week 24, • Proportion of patients with a decrease of ≥2 points from baseline in MG-ADL score at Week 24, • Proportion of patients with a decrease of ≥3 points from baseline in QMG score at Week 24, • Proportion of patients who achieved minimal symptomatic expression (MSE, defined as having MG-ADL score of 0 or 1) at Week 24, Change from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 24

Interventions

DRUGPlacebo contains excipients only and is visually indistinguishable from the Telitacicept

Sponsors

Vor Biopharma Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
• Change from baseline in MG Quality of Life scale (MG-QOL15r) at Week 24, • Proportion of patients with a decrease of ≥2 points from baseline in MG-ADL score at Week 24, • Proportion of patients with a decrease of ≥3 points from baseline in QMG score at Week 24, • Proportion of patients who achieved minimal symptomatic expression (MSE, defined as having MG-ADL score of 0 or 1) at Week 24, Change from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 24

Countries

Belgium, Czechia, Denmark, France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026