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

Phase 2

Recruiting

• Conditions: Myasthenia Gravis, Generalized
• Interventions: Drug: Tocilizumab Injection

• Registration Number: NCT05716035
• Lead Sponsor: Tang-Du Hospital

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-08
• Study Start: 2023-04-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tocilizumab	Tocilizumab Injection	Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs)	From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)

Secondary Outcome Measures

Name	Time	Method
Change in Quantitative Myasthenia Gravis (QMG) scores.	16 weeks
Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks	16 weeks
Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks	16 weeks
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score	16 weeks
Change in Myasthenia Gravis Composite (MGC) score	16 weeks
Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.	16 weeks

Trial Locations

Locations (6)

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

Tianjin medical university general hospital; 🇨🇳 Tianjin, Tianjin, China

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

Tangdu Hospital, The Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China