Clinical trial · Interventional

Telitacicept and Low-dose Steroids in Refractory Myasthenia Gravis

The Efficacy and Safety of Telitacicept Combined With Low-dose Steroids in Patients With Refractory Myasthenia Gravis

NCT06723548CI-TRIAL-00083491not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study is designed to explore the efficacy and safety of Telitacicept combined with low-dose steroids for the treatment of refractory MG, and to investigate related biomarkers such as immunoglobulins, BlyS/APRIL, and AChR-Ab titers, in order to clarify whether Telitacicept can rapidly and effectively help achieve MG treatment goals and assist in steroid reduction.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Autoimmune Diseases	—	UNRESOLVED	—
Myasthenia Gravis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Telitacicept	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Patients with refractory MG treated with Telitacicept combined with low-dose steroids
description
This is an open-label, single-arm exploratory study of Telitacicept (240mg weekly, then every two weeks after achieving MMS or QMG reduction of ≥ 6 points) combined with a gradual reduction of steroids and other immunosuppressants. When the steroid dose is reduced to 5mg/day or 10mg/every other day, Telitacicept can be reduced to 160mg, administered subcutaneously every two weeks.
interventionNames
1. Drug: Telitacicept

Primary outcomes (2)

measure
The change in patients' ADL scores
timeFrame
from baseline to week 52
description
The variation in ADL scores at 52 weeks compared to baseline in patients. Total MG -ADL scores range from 0 (normal) to 24 (severe).
measure
The change in patients' QMG scores

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 85 Years

Show eligibility criteria text

Inclusion Criteria:

* Age between 18-85 years, both genders included；
* Meet the diagnostic criteria of the 2020 Chinese MG guidelines, with positive serological testing for AChR-Ab;
* Clinical classification of Type I to Type IVa according to the MGFA;
* Meet the criteria for refractory MG in the 2022 Japanese MG guidelines: poor response to standard treatment, intolerance to standard treatment drugs due to adverse reactions, frequent relapses/exacerbations after reduction of standard treatment drugs, frequent need for rescue treatment due to disease fluctuations, frequent myasthenic crises, and comorbidities that limit the use of standard treatment;
* Patients with unstable symptoms (MG-ADL score ≥6 or QMG ≥8) despite treatment with standard therapeutic regimens before enrollment, defined as follows:

  1. Patients on monotherapy with corticosteroids: a corticosteroid dose ≤60mg/d, and a stable dose for at least 1 month before enrollment;
  2. Patients on combination therapy with corticosteroids and other immunosuppressants: a corticosteroid dose ≤60mg/d, and a stable dose for at least 1 month before enrollment, while other immunosuppressants such as azathioprine, methotrexate, tacrolimus, and mycophenolate mofetil have been stable for 6 months prior to the study start and will remain stable during the study period;
* Patients must provide written informed consent.

Exclusion Criteria:

* Patients with active infections, such as herpes zoster, HIV, active pulmonary tuberculosis, or active hepatitis;
* Patients with thymic tumors or those who have undergone thymectomy within the past 6 months;
* Patients with coexisting malignant tumors;
* Patients with severe hepatic or renal insufficiency;
* Patients who have received intravenous immunoglobulin or undergone plasmapheresis within the last 2 months;
* Patients who have received any live vaccines within the last 3 months or plan to receive any vaccines during the study period;
* Women who are currently pregnant or breastfeeding, and patients who plan to conceive during the trial period;
* Patients with allergies to human-derived biological products;
* Patients who have participated in any clinical trial within the last 28 days or within 5 half-lives of the study medication (whichever is longer);
* Any other patients deemed unsuitable for enrollment by the investigator (e.g., severe psychiatric disorders).

References

Publications (0)

Data not yet available

No reference posted for this study.