Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis

Myasthenia Gravis, Generalized Clinical Trial

— tMG-E  

Official title:

A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716035
• Other study ID #: V1.0, 20221201
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of tocilizumab in the treatment of generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study tMG(NCT05067348).

Description:

tMG-E was an extension study designed to provide the participants who completed Study tMG an opportunity to receive tocilizumab and collect clinical data to provide long-term safety and efficacy information on tocilizumab in participants with gMG. After receiving blinded study treatment (tocilizumab or placebo) in Study tMG for 16 weeks, participants were eligible to enroll in the tMG-E extension study. Participants were to enter Study tMG-E within 8 weeks after completing their Week 16 visit in Study tMG. Study tMG-E consisted of an Open-Label treatment Phase up to 16 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Participant has completed Study tMG.

2. Participant has given written informed consent.

3. MG-ADL score = 5 points, or a decrease of = 3 points relative to the baseline MG-ADL of the tMG study

Exclusion Criteria:

1. Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the past 4 weeks;

2. Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study;

3. planned thymectomy during RCP;

4. Received IVIG or plasma exchange in the past 4 weeks;

5. Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis
• Myasthenia Gravis, Generalized

Intervention

Drug:
• Tocilizumab Injection
Participants will receive IV tocilizumab

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Huashan Hospital	Shanghai	Shanghai
China	Tianjin medical university general hospital	Tianjin	Tianjin
China	Tangdu Hospital, The Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)		From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)
Secondary	Change in Quantitative Myasthenia Gravis (QMG) scores.		16 weeks
Secondary	Proportion of subjects with both (1) = 3-point improvement in QMG and (2) lasts =4 weeks		16 weeks
Secondary	Proportion of subjects with both (1) = 2-point improvement in MG-ADL and (2) lasts =4 weeks		16 weeks
Secondary	Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score		16 weeks
Secondary	Change in Myasthenia Gravis Composite (MGC) score		16 weeks
Secondary	Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.		16 weeks