Myasthenia Gravis, GeneralizedPhase 2/3tMG-ENCT05716035
Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis
A Phase 2/3 study testing Tocilizumab Injection in people with Myasthenia Gravis, Generalized, run by Tang-Du Hospital at 6 sites in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myasthenia Gravis, Generalized
- What is being tested?
- Tocilizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesChina
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has completed Study tMG.
- Participant has given written informed consent.
- MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study
Who cannot join
- 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;
- Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study;
- planned thymectomy during RCP;
- Received IVIG or plasma exchange in the past 4 weeks;
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Fudong Shi, MD,PHD, +86-22-60817429, fshi@tmu.edu.cn
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Huan Yang, MD,PHD, yxyx69@gahoo.com.cn
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Hongyu Zhou, MD,PHD, zhouhy@scu.edu.cn
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Chongbo Zhao, MD,PHD, 86-21-52889999, zhao_chongbo@fudan.edu.cn
- Recruiting
Tianjin medical university general hospital
Tianjin, Tianjin Municipality, 300052
Chao Zhang, MD,PHD, +86-22-60362255, chaozhang@tmu.edu.cn
- Recruiting
Tangdu Hospital, The Fourth Military Medical University
Xi'an, Shaanxi, 710038
Ting Chang, 02984778845, changting1981@163.com
Zhe Ruan, ruanzhe573291596@126.com
About this study
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)
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).
Read the 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.
- Conditions
- Myasthenia Gravis, Generalized
- Being tested
- Tocilizumab Injection
- Keywords
- Generalized Myasthenia Gravis, Tocilizumab, Open-label
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab InjectionDrug
Participants will receive IV tocilizumab
| Study group | Role | What they receive |
|---|---|---|
| tocilizumab | Experimental | Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period. Receives: Drug: Tocilizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)
Secondary outcomes (6)
Change in Quantitative Myasthenia Gravis (QMG) scores.
Measured: 16 weeks
Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks
Measured: 16 weeks
Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks
Measured: 16 weeks
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score
Measured: 16 weeks
Change in Myasthenia Gravis Composite (MGC) score
Measured: 16 weeks
Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Apr 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis, GeneralizedStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, changting, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716035
- Sponsor's protocol ID
- V1.0, 20221201
- Acronym
- tMG-E
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05716035
- Acronym / sponsor ID
- tMG-E / V1.0, 20221201
- Conditions
- Myasthenia Gravis, Generalized
- Keywords
- Generalized Myasthenia Gravis, Tocilizumab, Open-label
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tocilizumab | Experimental | Drug: Tocilizumab InjectionParticipants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant has completed Study tMG.
- Participant has given written informed consent.
- MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study
Key exclusion criteria (5 listed)
- 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;
- Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study;
- planned thymectomy during RCP;
- Received IVIG or plasma exchange in the past 4 weeks;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocilizumab InjectionParticipants will receive IV tocilizumab | Drug | tocilizumab |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)
6 secondary outcomes
Change in Quantitative Myasthenia Gravis (QMG) scores.
Time frame: 16 weeks
Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks
Time frame: 16 weeks
Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks
Time frame: 16 weeks
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score
Time frame: 16 weeks
Change in Myasthenia Gravis Composite (MGC) score
Time frame: 16 weeks
Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Myasthenia Gravis, Generalized
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
RecruitingPhase 3
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Myasthenia Gravis
RecruitingPhase 2/3
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
Not yet recruitingEarly Phase 1
A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Refractory Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tocilizumab Injection in people with Myasthenia Gravis, Generalized, run by Tang-Du Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.