Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05737160
Other study ID # 18C029
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 28, 2023
Est. completion date May 2027

Study information

Verified date October 2023
Source RemeGen Co., Ltd.
Contact Binghua Xiao
Phone 86-101-58076833
Email binghua.xiao@remegen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This study consists of a screening period, a double-blind treatment period (part A) and an open-label treatment period (part B). After screening, eligible subjects will be randomized in a 1: 1 ratio to receive either subcutaneous Telitacicept 240 mg or placebo once a week for 24 doses (part A). Completing part A, subjects will automatically enter part B. In part B, all subjects will receive weekly subcutaneous Telitacicept 240 mg for 24 weeks.


Read more »

Study Design


Intervention

Biological:
Telitacicept
Administered as an SC infusion
Drug:
Placebo
Administered as an SC infusion

See more »

Sponsors (1)

Lead Sponsor Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in MG-ADL The MG-ADL is an 8-item patient-reported scale that measures MG symptoms and functional status. Each item ranges from 0 to 3 for a total score range of 0 to 24. Week 24
Secondary Change from baseline in MG-ADL The MG-ADL is an 8-item patient-reported scale that measures MG symptoms and functional status. Each item ranges from 0 to 3 for a total score range of 0 to 24. Weeks12, 36, 48
Secondary Change from baseline in QMG The quantitative myasthenia gravis (QMG) score is a 13-item scale used to quantify disease severity in myasthenia gravis (MG). Total QMG score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits). Weeks 12, 24, 36, 48
Secondary Proportion of subjects with = 3 points reduction from baseline in MG-ADL The MG-ADL is an 8-item patient-reported scale that measures MG symptoms and functional status. Each item ranges from 0 to 3 for a total score range of 0 to 24. Weeks 24, 48
Secondary Proportion of subjects with a decrease of = 5 points from baseline in QMG The quantitative myasthenia gravis (QMG) score is a 13-item scale used to quantify disease severity in myasthenia gravis (MG). Total QMG score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits). Weeks 24, 48
See also
  Status Clinical Trial Phase
Completed NCT02565576 - Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis Phase 2
Completed NCT04115293 - Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis Phase 3
Recruiting NCT04224506 - A Pilot Study to Explore the Role of Gut Flora in Myasthenia Gravis
Recruiting NCT06455709 - Markers of Favorable Response to Complement Inhibitors Therapy
Recruiting NCT04431895 - Safety And Efficacy Of Tofacitinib In Patients With Refractory Myasthenia Gravis: A Pilot Study Early Phase 1
Recruiting NCT05067348 - Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis Phase 2
Withdrawn NCT03165435 - A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis Phase 2/Phase 3
Recruiting NCT05214612 - Predictors and Prognostic Factors of Myasthenia Gravis Outcome
Recruiting NCT05868837 - Rituximab EfFicacy IN MyasthEnia Gravis (REFINE) Phase 3
Recruiting NCT06282159 - A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC) Phase 2
Recruiting NCT04146051 - Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG) Phase 2
Completed NCT03759366 - A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG) Phase 3
Completed NCT02473952 - A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis Phase 2
Completed NCT00683969 - A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis Phase 3
Completed NCT03304054 - Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG Phase 3
Recruiting NCT05716035 - Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis Phase 2/Phase 3