Efficacy and Safety of Tocilizumab in the Treatment of Ge... | NCT05067348

Studies
Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

NCT05067348

Sponsor

Tang-Du Hospital

Status

Recruiting

Last Update Posted

May 1, 2025Actual

Enrollment

64Estimated

Phase

Phase 2

Conditions

Myasthenia Gravis, Generalized

Interventions

Tocilizumab Injectable Product

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Mar 30, 2026Estimated

First Submitted Date

Sep 23, 2021

First Submission Date that Met QC Criteria

Sep 23, 2021

First Posted Date

Oct 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2025

Last Update Posted Date

May 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tocilizumab	Experimental	Participants will receive tocilizumab administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.	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.	Drug: Tocilizumab Injectable Product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tocilizumab Injectable Product	Drug	Participants will receive IV tocilizumab	Placebo Tocilizumab

Measure	Description	Time Frame
Change in Quantitative Myasthenia Gravis (QMG) scores.		16 weeks

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
1. Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization;
2. 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.

Exclusion Criteria:

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;
Received IVIG or plasma exchange within 4 weeks before randomization;
Unresected thymoma.
History of other tumor diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ting Chang, MD,PHD	Contact	+86-29-84778845		changting1981@163.com
Zhe Ruan	Contact	+86-29-84778845		ruanzhe573291596@126.com

Overall Officials

Name	Affiliation	Role
Ting Chang, MD,PHD	The Second Affiliated Hospital of Air Force Military Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tiantan Hospital, Capital Medical University	Not yet recruiting	Beijing	Beijing Municipality	100050	China

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms