A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)
Recruiting
Phase 3
Interventional Study
Myasthenia Gravis, Ocular
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- RemeGen Co., Ltd. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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 rec…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
1. Voluntarily signed the informed consent form.
2. Age 12 to 80 years, inclusive, male or female.
3. Body weight ≥30 kg.
4. Diagnosis of Myasthenia Gravis (MG) with documented clinical features consistent with the disease.
5. Myasthenia Gravis Foundation of America (MGFA) Clini…
Contacts
No contact information available.