Myasthenia Gravis, GeneralizedPhase 2tMGNCT05067348
Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
A Phase 2 study testing Tocilizumab Injectable Product in people with Myasthenia Gravis, Generalized, run by Tang-Du Hospital at 6 sites in China.
Trial summary
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension. 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 Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 6 sitesChina
- Study dates
- 21 Jul 2022to 30 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of MG with anti-AChRantibody.
- MGFA Clinical Classification Class II, III, or IV.
- MG-ADL score of 5 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.
- QMG score of 11 or greater.
- Subjects must be on:
- Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization;
- Corticosteroids, with no dose increase within 4 weeks prior to randomization; or/and c. non-steroidal IST (including azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.
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 4 weeks before randomization;
- Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis;
- Human immunodeficiency virus (HIV) infection;
- Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and/or radiotherapy at any time;
- Received rituximab treatment in the past 6 months before randomization;
- Received tocilizumab or eculizumab treatment within 3 months before randomization;
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- Received IVIG or plasma exchange within 4 weeks before randomization;
- Unresected thymoma.
- History of other tumor diseases.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
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
- Not yet recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Chongbo Zhao, MD,PHD, 86-21-52889999, zhao_chongbo@fudan.edu.cn
- Not yet recruiting
Tianjin medical university general hospital
Tianjin, Tianjin Municipality, 300052
Chao Zhang, MD,PHD, +86-22-60362255
- 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 Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled study, to be conducted at 6 study sites. Approximately 64 subjects will be enrolled. Patients with MG who are positive for anti-AChR antibodies will be enrolled. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with MGFA classification II, III, or IV disease, MG-ADL score ≥ 5, QMG score ≥ 11, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study.
All subjects who complete the randomized controlled period will have the option to enroll in a 1-year open-label period.
- Conditions
- Myasthenia Gravis, Generalized
- Being tested
- Tocilizumab Injectable Product
- Keywords
- Generalized Myasthenia Gravis, Tocilizumab
- 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 Injectable ProductDrug
Participants will receive IV tocilizumab
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Participants will receive tocilizumab administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period. Receives: Drug: Tocilizumab Injectable Product |
| Placebo | Placebo comparator | Participants will receive placebo administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period. Receives: Drug: Tocilizumab Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quantitative Myasthenia Gravis (QMG) scores.
Measured: 16 weeks
Secondary outcomes (7)
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 (MGQOL-15r) score.
Measured: 16 weeks
Change in Myasthenia Gravis Impairment Index (MGII) score.
Measured: 16 weeks
Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the randomized controlled period and open-label period.
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 posted5 Oct 2021
- Study start21 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Mar 2026 (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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting Chang, MD,PHD, Study director, The Second Affiliated Hospital of Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067348
- Sponsor's protocol ID
- V4.0, 20220410
- Acronym
- tMG
- Status last verified
- Apr 2025
- First submitted
- 23 Sep 2021
- Last updated
- 1 May 2025
- 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT05067348
- Acronym / sponsor ID
- tMG / V4.0, 20220410
- Conditions
- Myasthenia Gravis, Generalized
- Keywords
- Generalized Myasthenia Gravis, Tocilizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 5 Oct 2021 (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.
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
Detailed description
This study is a randomized, double-blind, placebo-controlled study, to be conducted at 6 study sites. Approximately 64 subjects will be enrolled. Patients with MG who are positive for anti-AChR antibodies will be enrolled. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with MGFA classification II, III, or IV disease, MG-ADL score ≥ 5, QMG score ≥ 11, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study.
All subjects who complete the randomized controlled period will have the option to enroll in a 1-year open-label period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: Tocilizumab Injectable ProductParticipants will receive tocilizumab administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period. |
| Placebo | Placebo comparator | Drug: Tocilizumab Injectable ProductParticipants will receive placebo administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of MG with anti-AChRantibody.
- MGFA Clinical Classification Class II, III, or IV.
- MG-ADL score of 5 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.
- QMG score of 11 or greater.
- Subjects must be on:
Key exclusion criteria (9 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 4 weeks before randomization;
- Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis;
- Human immunodeficiency virus (HIV) infection;
- Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and/or radiotherapy at any time;
- Received rituximab treatment in the past 6 months before randomization;
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 Injectable ProductParticipants will receive IV tocilizumab | Drug | Placebo, Tocilizumab |
Primary outcome
Change in Quantitative Myasthenia Gravis (QMG) scores.
Time frame: 16 weeks
7 secondary outcomes
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 (MGQOL-15r) score.
Time frame: 16 weeks
Change in Myasthenia Gravis Impairment Index (MGII) score.
Time frame: 16 weeks
Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the randomized controlled period and open-label period.
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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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.
Ting Chang, MD,PHD study director
The Second Affiliated Hospital of Air Force Military Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab Injectable Product 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 May 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Chang, MD,PHD (+86-29-84778845, changting1981@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quantitative Myasthenia Gravis (QMG) scores. (time frame: 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 1 May 2025.