Myasthenia Gravis, OcularPhase 3NCT07249632
A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)
A Phase 3 study testing Telitacicept in people with Myasthenia Gravis, Ocular, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Myasthenia Gravis, Ocular
- What is being tested?
- Telitacicept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2026to 28 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Type I.
- On a stable standard-of-care (SOC) treatment regimen.
Who cannot join
- 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.
- Current active hepatitis or history of severe liver disease.
- Positive for HIV antibodies.
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- Positive for syphilis antibodies (non-specific or specific).
- Poorly controlled diabetes mellitus, defined as HbA1c >9.0% or fasting blood glucose ≥11.1 mmol/L.
- Subjects with thymoma (classified as ≤ Stage II for benign and ≥ Stage III for malignant according to the Masaoka staging system) .
- Presence of uncontrolled chronic degenerative diseases, psychiatric disorders, or neurological diseases other than MG that could interfere with study assessments.
- Other diseases causing ptosis, peripheral muscle weakness, or diplopia (e.g., Graves' ophthalmopathy, blepharospasm, progressive external ophthalmoplegia, muscular dystrophy, brainstem or cranial nerve lesions, etc.).
- Known allergy to human-derived biological products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100000
Jian Yin, +86-10-85138105, m13611177824@163.com
About this study
Official title: A Phase III Trial of Telitacicept in Patients With Ocular Myasthenia Gravis
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.
Read the detailed description
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of Telitacicept in subjects with Ocular Myasthenia Gravis (OMG). The study will be conducted at multiple centers.
Eligible subjects will be randomized in a 1:1 ratio to one of two treatment arms:
Arm 1: Telitacicept Arm 2: Placebo Randomization will be stratified by two factors: Acetylcholine Receptor (AChR) antibody status (positive vs. negative) and age (<18 years vs. ≥18 years).
Primary Objective:
To evaluate the efficacy of Telitacicept compared to placebo in the treatment of subjects with Ocular Myasthenia Gravis.
Primary Endpoint:
Change from baseline in the Myasthenia Gravis Impairment Index (Patient-Reported Outcomes) [MGII (PRO)] ocular score at Week 24.
Study Population:
A total of approximately 120 subjects will be enrolled.
Intervention:
Subjects will receive either Telitacicept or a matching placebo. The dose will be determined based on the subject's age and body weight at baseline.
The placebo will be identical in appearance to Telitacicept to maintain the blind.
Safety Assessments:
Safety and tolerability will be assessed through the monitoring and recording of adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, and regular laboratory tests (hematology, serum chemistry, urinalysis). An independent Data Monitoring Committee (DMC) will be established to monitor the safety of the trial.
- Conditions
- Myasthenia Gravis, Ocular
- Being tested
- Telitacicept, Placebo
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
The dosage is administered based on the subject's age and baseline body weight.
PlaceboDrug
The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept | Experimental | Not described Receives: Drug: Telitacicept |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the MGII (PRO) ocular score
at Week 24
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (7)
Change from baseline in the MGII (PRO + PE) ocular score
at Week 24
Measured: From enrollment to the end of treatment at 24 weeks
Change from baseline in the MG-ADL ocular score
at Week 24
Measured: From enrollment to the end of treatment at 24 weeks
Change from baseline in the MG Clinical Absolute Score ocular score
at Week 24
Measured: From enrollment to the end of treatment at 24 weeks
Change from baseline in the total MGII score
at Week 24
Measured: From enrollment to the end of treatment at 24 weeks
Change from baseline in the total MG-ADL score
at Week 24
Measured: From enrollment to the end of treatment at 24 weeks
Change from baseline in the MG-QOL15r total score
at Week 24
Measured: From enrollment to the end of treatment at 24 weeks
Incidence and severity of adverse events
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: From signing of informed consent until 4 weeks after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start13 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis, OcularStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital, Beijing Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249632
- Sponsor's protocol ID
- RC18-C307
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of Telitacicept in Patients With Ocular Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07249632
- Acronym / sponsor ID
- RC18-C307
- Conditions
- Myasthenia Gravis, Ocular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital, Beijing Hospital
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of Telitacicept in subjects with Ocular Myasthenia Gravis (OMG). The study will be conducted at multiple centers.
Eligible subjects will be randomized in a 1:1 ratio to one of two treatment arms:
Arm 1: Telitacicept Arm 2: Placebo Randomization will be stratified by two factors: Acetylcholine Receptor (AChR) antibody status (positive vs. negative) and age (<18 years vs. ≥18 years).
Primary Objective:
To evaluate the efficacy of Telitacicept compared to placebo in the treatment of subjects with Ocular Myasthenia Gravis.
Primary Endpoint:
Change from baseline in the Myasthenia Gravis Impairment Index (Patient-Reported Outcomes) [MGII (PRO)] ocular score at Week 24.
Study Population:
A total of approximately 120 subjects will be enrolled.
Intervention:
Subjects will receive either Telitacicept or a matching placebo. The dose will be determined based on the subject's age and body weight at baseline.
The placebo will be identical in appearance to Telitacicept to maintain the blind.
Safety Assessments:
Safety and tolerability will be assessed through the monitoring and recording of adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, and regular laboratory tests (hematology, serum chemistry, urinalysis). An independent Data Monitoring Committee (DMC) will be established to monitor the safety of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telitacicept | Experimental | Drug: Telitacicept |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Type I.
Key exclusion criteria (12 listed)
- 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.
- Current active hepatitis or history of severe liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelitaciceptThe dosage is administered based on the subject's age and baseline body weight. | Drug | Telitacicept |
| PlaceboThe placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects. | Drug | Placebo |
Primary outcome
Change from baseline in the MGII (PRO) ocular score
Time frame: From enrollment to the end of treatment at 24 weeks
at Week 24
7 secondary outcomes
Change from baseline in the MGII (PRO + PE) ocular score
Time frame: From enrollment to the end of treatment at 24 weeks
Change from baseline in the MG-ADL ocular score
Time frame: From enrollment to the end of treatment at 24 weeks
Change from baseline in the MG Clinical Absolute Score ocular score
Time frame: From enrollment to the end of treatment at 24 weeks
Change from baseline in the total MGII score
Time frame: From enrollment to the end of treatment at 24 weeks
Change from baseline in the total MG-ADL score
Time frame: From enrollment to the end of treatment at 24 weeks
Change from baseline in the MG-QOL15r total score
Time frame: From enrollment to the end of treatment at 24 weeks
Incidence and severity of adverse events
Time frame: From signing of informed consent until 4 weeks after the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telitacicept in people with Myasthenia Gravis, Ocular, run by RemeGen Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the MGII (PRO) ocular score (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.