Study of Telitacicept for Treating Generalized Myasthenia Gravis in Patients

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Generalized Myasthenia Gravis, a condition that causes muscle weakness. The treatment being tested is called Telitacicept, which is given as an injection. The study will compare the effects of Telitacicept to a placebo, which looks the same but does not contain the active medication. The main goal is to see how well Telitacicept works in improving the symptoms of Generalized Myasthenia Gravis.

Participants in the study will receive either Telitacicept or a placebo over a period of time. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the main part of the study. After this period, there will be an “open-label extension,” where all participants may receive Telitacicept. The study will last for several months, and participants will have regular check-ups to monitor their health and the effects of the treatment.

The purpose of this study is to evaluate the effectiveness and safety of Telitacicept in treating Generalized Myasthenia Gravis. Participants will be assessed on changes in their ability to perform daily activities and their overall quality of life. The study aims to provide valuable information on whether Telitacicept can be a beneficial treatment option for people with this condition.

1 joining the study

Upon joining the study, you will be required to provide signed informed consent. This means you agree to participate and follow the study procedures.

You must be at least 18 years old and have a confirmed diagnosis of generalized myasthenia gravis (gMG) with specific symptoms such as muscle weakness that fluctuates in severity.

2 screening and baseline assessment

During this phase, your medical history will be reviewed, and tests will be conducted to confirm your eligibility. This includes checking for positive antibodies against AChR or MuSK.

Your MG-ADL score and QMG score will be assessed to ensure they meet the required levels for participation.

3 randomization and treatment

You will be randomly assigned to receive either the telitacicept injection or a placebo. The placebo looks the same as the telitacicept injection but contains no active medication.

The treatment involves receiving a solution for injection in a pre-filled syringe. The frequency and dosage will be determined by the study protocol.

4 treatment period

The treatment period lasts for 24 weeks. During this time, you will continue to receive the assigned treatment and attend regular study visits.

Your progress will be monitored through various assessments, including changes in your MG-ADL and QMG scores.

5 evaluation of results

At the end of the 24-week treatment period, your results will be evaluated. This includes measuring changes in your MG-ADL score and other health indicators.

The study aims to determine the effectiveness of telitacicept compared to the placebo in improving symptoms of gMG.

6 open-label extension

After the initial 24-week period, there may be an opportunity to participate in an open-label extension. This means you could receive telitacicept regardless of your initial group assignment.

Participation in the extension is optional and will be discussed with you at the appropriate time.

Who Can Join the Study?

Patients must provide signed informed consent to participate in the study and agree to follow the study procedures.
Patients must be male or female and at least 18 years old at the time of screening.
Patients must have a prior confirmed diagnosis of generalized myasthenia gravis (gMG) with generalized muscle weakness. This means having a typical pattern of weakness that is mostly in the upper body, gets worse with activity, varies in severity, is more severe in the evening, and improves with rest. The diagnosis should meet at least one of the following tests:
- History of abnormal neuromuscular transmission shown by a test called single fiber electromyography or repetitive nerve stimulation.
- History of a positive edrophonium chloride test.
- Improvement in myasthenia gravis signs when taking oral acetylcholine esterase (AChE) inhibitors, as assessed by the treating physician.
Patients must have positive antibodies against AChR or MuSK at screening. These are specific proteins in the body that are tested to confirm the diagnosis.
Patients must have a MG-ADL score of 6 points or more at screening and baseline, with less than 50% of the total score related to eye symptoms. The MG-ADL score is a measure of daily living activities affected by myasthenia gravis.
Patients must have a QMG score of 11 points or more at screening and baseline. The QMG score is a measure of the severity of muscle weakness.
Patients can take up to 2 other medications if they meet the stability criteria before the start of the study.
Patients must agree to use highly effective contraception during the study.

Who Cannot Join the Study?

Patients who do not have Generalized Myasthenia Gravis cannot participate. This is a condition that causes muscle weakness.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population may not be eligible. This includes groups that might need special protection in research.
Patients who do not meet other specific health criteria set by the study may be excluded. These criteria are usually detailed in the study protocol.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Neurologia Slaska Centrum Medyczne	Katowice	Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Hospital Universitario Basurto	Bilbao	Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Fondazione Istituto G. Giglio Di Cafalu	Cefalu'	Italy
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Fakultni Nemocnice Brno	Brno	Czechia
Centre Hospitalier Universitaire De Nice	Nice	France
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Neurocentrum Bydgoszcz Sp. z o.o.	Bydgoszcz	Poland
Rigshospitalet	Copenhagen	Denmark
Neuroprotect Sp. z o.o.	Warsaw	Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD	Sofia	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
University Hospital Ostrava	Ostrava	Czechia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD	Sofia	Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Clinirem Sp. z o.o.	Lublin	Poland
Centrum Medyczne HOPE Clinic Sebastian Szklener	Lublin	Poland
Mckitpndr Ieyksvjnvo Cnbfxwxv Sfktiagp Svh z owyp	Warsaw	Poland
Akbddd Utcehqyibs Hwgjscqk	Aarhus	Denmark
Usylfgprxoilyb Crjiufm Kyzhcwvsx	Gdansk	Poland
Hmbcegou Vnpc dnhaspiw	Barcelona	Spain
Mgxhbantju shpdxn	Brno	Czechia

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	30.11.2024
Bulgaria	Not yet recruiting	30.11.2024
Czechia	Recruiting	30.11.2024
Denmark	Not recruiting	30.11.2024
France	Recruiting	30.11.2024
Italy	Not yet recruiting	30.11.2024
Poland	Recruiting	30.11.2024
Spain	Not yet recruiting	30.11.2024

Trial locations

Investigated drugs:

Telitacicept

Telitacicept is a medication being studied for its potential to help people with generalized myasthenia gravis, a condition that causes muscle weakness. This medication works by targeting specific parts of the immune system that may be overactive in people with this condition. By doing so, it aims to reduce the symptoms and improve muscle strength and function. The study is designed to see how effective and safe telitacicept is for patients with this condition.

Generalized Myasthenia Gravis – Generalized Myasthenia Gravis is an autoimmune disorder that affects the communication between nerves and muscles, leading to muscle weakness. It occurs when the immune system mistakenly attacks the body’s own tissues, specifically targeting the receptors that receive nerve signals. This disruption causes muscles to become weak and easily fatigued, especially after periods of activity. The condition often affects muscles that control eye and eyelid movement, facial expression, and swallowing, but it can also impact other muscle groups. Symptoms can fluctuate, with periods of improvement and worsening. Over time, the muscle weakness can become more severe and widespread.

Trial ID:

2024-512126-29-00

Protocol code:

RC18G006

NCT ID:

NCT06456580

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Telitacicept for Treating Generalized Myasthenia Gravis in Patients

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