A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)
ConditionMyasthenia Gravis, Ocular
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-80
SponsorRemeGen Co., Ltd.
About this trial
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Telitacicept for the treatment of Ocular Myasthenia Gravis (OMG).Approximately 120 eligible subjects aged 12 to 80 years with a diagnosis of OMG (Myasthenia Gravis Foundation of America \[MGFA\] Clinical Classification Type I) will be randomized in a 1:1 ratio to receive either Telitacicept or a matching placebo. Subjects must be on a stable standard-of-care therapy and have an MG Impairment Index (PRO) ocular score of ≥6 at screening and baseline.The dose is age and weight based.The primary objective is to evaluate the efficacy of Telitacicept compared to placebo in treating OMG.The primary efficacy endpoint is the change from baseline in the MGII (PRO) ocular score at Week 24. Secondary endpoints include changes from baseline in other ocular and total scores from MGII, Myasthenia Gravis-Activities of Daily Living (MG-ADL), MG Clinical Absolute Score, and the 15-item Myasthenia Gravis Quality of Life Revised scale (MG-QOL15r). Safety and tolerability will be monitored throughout the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily signed the informed consent form.
Age 12 to 80 years, inclusive, male or female.
Body weight ≥30 kg.
Diagnosis of Myasthenia Gravis (MG) with documented clinical features consistent with the disease.
Disqualifiers
Concomitant autoimmune diseases requiring systemic corticosteroid therapy.
Clinically significant laboratory abnormalities.
Use of other immunosuppressants (not part of the stable SOC) within 1 month prior to randomization.
Presence of an acute or chronic infection requiring treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Telitacicept
DrugThe dosage is administered based on the subject's age and baseline body weight.
Placebo
DrugThe placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: TelitaciceptExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the MGII (PRO) ocular score
at Week 24
Time frame
From enrollment to the end of treatment at 24 weeksSecondary outcomes
1
Change from baseline in the MGII (PRO + PE) ocular score
at Week 24
Time frame
From enrollment to the end of treatment at 24 weeks2
Change from baseline in the MG-ADL ocular score
at Week 24
Time frame
From enrollment to the end of treatment at 24 weeks3
Change from baseline in the MG Clinical Absolute Score ocular score
at Week 24
Time frame
From enrollment to the end of treatment at 24 weeks4
Change from baseline in the total MGII score
at Week 24
Time frame
From enrollment to the end of treatment at 24 weeksOther outcomes
1
Number and proportion of subjects who achieve MSE, defined as an MG-ADL total score of 0 or 1
at Week 24
Time frame
From enrollment to the end of treatment at 24 weeks2
Number and proportion of subjects in each MGFA-PIS category
at Week 24
Time frame
From enrollment to the end of treatment at 24 weeks3
Number and proportion of subjects in each PGI-S and PGI-C category
at Week 24
Time frame
From enrollment to the end of treatment at 24 weeksSponsors and contacts
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Source ClinicalTrials.gov