Clinical Trials List
Protocol NumberVIB0551.P3.S1
NCT Number(ClinicalTrials.gov Identfier)NCT04524273
Active
2021-01-01 - 2029-07-31
Phase III
Recruiting4
Terminated4
ICD-10G70.00
Myasthenia gravis without (acute) exacerbation
ICD-10G70.01
Myasthenia gravis with (acute) exacerbation
ICD-9358.0
Myasthenia gravis
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis
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Trial Applicant
MEDPACE TAIWAN LIMITED
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Sponsor
Viela Bio
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hong-Chou Kuo Division of Neurology
- 劉采薇 Division of Neurology
- 呂榮國 Division of Neurology
- Chin-Chang Huang Division of Neurology
- 張國軒 Division of Neurology
- 朱俊哲 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hou-Chang Chiu Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chi-Chao Chao Division of Neurology
- Jen Jen and I Su Division of Neurology
- 江樸田 Division of Neurology
- Ming-Jen Lee Division of Neurology
- Ming-Che Kuo Division of Neurology
- LI-KAI TSAI Division of Neurology
- 饒敦 Division of Neurology
- SUNG-TSANG HSIEH Division of Neurology
- CHIH-HAO CHEN Division of Neurology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 林典佑 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 蕭丞宗 Division of Neurology
- 賴冠霖 Division of Neurology
- Yi-Chu Liao Division of Neurology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Shu-Ping Chao Division of Neurology
- Hou-Chang Chiu Division of Neurology
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Myasthenia Gravis
Objectives
Primary Objective
To assess whether inebilizumab canreduce MG-related disability.
Secondary Objectives
1.To evaluate whether inebilizumab can reduce the frequency of MG exacerbations.
2.To evaluate whether inebilizumab can improve MG-related QOL.
3.To evaluate the safety and tolerability of inebilizumab in MG.
4.To characterize the PKprofile and immunogenicity of inebilizumab in patients with MG.
Test Drug
Inebilizumab
Active Ingredient
Inebilizumab
Dosage Form
IVT
Dosage
100 mg/vial inebilizumab
Endpoints
Primary Endpoint
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at end of the RCP (Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population).
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at end of the RCP (Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population).
Inclution Criteria
1.Male or female subjects ≥18 years old(in Japan, subjects < 20 years old must also have consent of a parent or other legally authorized representative).
2.Written informed consent and any locally required authorization (eg,Health Insurance Portability and Accountability Act [HIPAA] in the United States of America, European Union Data Privacy Directive in the European Union) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
3.Diagnosis of MGdefined as:
a.Positive serologic test for anti-AChRor anti-MuSKantibodytitersas confirmed at screening (one retest allowed), and
b.At least one of the following:
o History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or
o History of positive anticholinesterase test (eg, edrophonium chloride test); or
o Patient demonstrated improvement in MGsigns on oral cholinesterase inhibitors, as assessed by the treating physician; or
o Clinical syndrome consistent with a diagnosis of MG, and not otherwise explained by another condition.
4.MGFAClinical Classification Class II, III, or IV at the time of screening and randomization.
5.MG-ADLscore of 6 or greaterat screening and at randomization with>50% of this score attributed to non-ocular items.
6.QMGscore of 11or greater at screening and at randomization.
7.Subjects mustbe on:
a.Corticosteroids only, with nodose increase within 4 weeks prior to randomization, or
b.One allowednon-steroidal IST,with continuous use for at least 6 months prior to randomizationand no dose increase within 4 months prior to randomization, or
c.Combination of (1) corticosteroids with no dose increase within4 weeks prior to randomizationand (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomizationand no dose increase within 4 months prior to randomization.Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.
8.Willing and able to comply with the protocol, complete study assessments,and return for follow-up visits.
9.Females of childbearing potential who are sexually active with a non-sterilized malepartner must use at least one highly effective contraception method (Table 1) from the time of screening and for 6 months after the final dose of IP. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (ie,bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause and a follicle-stimulating hormone [FSH] level in the postmenopausal range [≥ 16.70 mIU/mL]). If the FSH level is not in thepostmenopausal range in a subject with amenorrhea, she may still enroll in the study but must follow the same contraception requirements as women of childbearing potential.
10.Non-sterilized males who are sexually active with a female partner of childbearingpotential must use a condom from Day 1 for the duration of the study and for 3 months after the last dose of IP. Because male condom is not a highly effective contraception method, it is strongly recommended that female partners of a male study subject also use a highly effective method of contraception throughout this period (Table 1).
11.Vital signs, electrocardiogram (ECG), and laboratory parameters within the normal ranges at screening, or, if outside normal ranges, deemed not clinically significant by the Investigator.
2.Written informed consent and any locally required authorization (eg,Health Insurance Portability and Accountability Act [HIPAA] in the United States of America, European Union Data Privacy Directive in the European Union) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
3.Diagnosis of MGdefined as:
a.Positive serologic test for anti-AChRor anti-MuSKantibodytitersas confirmed at screening (one retest allowed), and
b.At least one of the following:
o History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or
o History of positive anticholinesterase test (eg, edrophonium chloride test); or
o Patient demonstrated improvement in MGsigns on oral cholinesterase inhibitors, as assessed by the treating physician; or
o Clinical syndrome consistent with a diagnosis of MG, and not otherwise explained by another condition.
4.MGFAClinical Classification Class II, III, or IV at the time of screening and randomization.
5.MG-ADLscore of 6 or greaterat screening and at randomization with>50% of this score attributed to non-ocular items.
6.QMGscore of 11or greater at screening and at randomization.
7.Subjects mustbe on:
a.Corticosteroids only, with nodose increase within 4 weeks prior to randomization, or
b.One allowednon-steroidal IST,with continuous use for at least 6 months prior to randomizationand no dose increase within 4 months prior to randomization, or
c.Combination of (1) corticosteroids with no dose increase within4 weeks prior to randomizationand (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomizationand no dose increase within 4 months prior to randomization.Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.
8.Willing and able to comply with the protocol, complete study assessments,and return for follow-up visits.
9.Females of childbearing potential who are sexually active with a non-sterilized malepartner must use at least one highly effective contraception method (Table 1) from the time of screening and for 6 months after the final dose of IP. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (ie,bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause and a follicle-stimulating hormone [FSH] level in the postmenopausal range [≥ 16.70 mIU/mL]). If the FSH level is not in thepostmenopausal range in a subject with amenorrhea, she may still enroll in the study but must follow the same contraception requirements as women of childbearing potential.
10.Non-sterilized males who are sexually active with a female partner of childbearingpotential must use a condom from Day 1 for the duration of the study and for 3 months after the last dose of IP. Because male condom is not a highly effective contraception method, it is strongly recommended that female partners of a male study subject also use a highly effective method of contraception throughout this period (Table 1).
11.Vital signs, electrocardiogram (ECG), and laboratory parameters within the normal ranges at screening, or, if outside normal ranges, deemed not clinically significant by the Investigator.
Exclusion Criteria
Exclusion Criteria
If an individual meets any of the following criteria, he or she is ineligible for this study:
1.Any condition hat,in the opinion of the Investigator,would place the patient at unacceptable risk of complications,interfere with evaluation of the IP,or confound the interpretation of patient safety or study results.
2.Lactating or pregnant females, or females who intend to become pregnant anytime from signing the informed consent form (ICF)throughout the RCPplus 6 months following last dose of IP.
3.History of drug or alcohol abuse within <1 year prior to screening, or any condition associated with poor compliance as judged by the Investigator.
4.Employees of the Sponsor, contract research organization(CRO), site staff, and their family members.
5.Currently committed to an institution by way of official or judicial order.
6.Subjects diagnosed with congenital myasthenic syndromes.
7.Known immunodeficiency disorder, including human immunodeficiency virus (HIV) infection.
8.Thymectomy within ≤12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the RCP.
9.Receipt of the following medications or treatments at any time prior to randomization:a.Alemtuzumab (Lemtrada®, Campath®)b.Total lymphoid irradiationc.Bone marrow transplantd.T-cell vaccination therapye.Natalizumab (Tysabri®)
10.Receipt of rituximab (MabThera®, Rituxan®), ocrelizumab (Ocrevus®), ofatumumab (Arzerra®), obinutuzumab (Gazyva®), inebilizumab, or any experimental B-cell depleting agent within the 6 months prior to Day 1, unless the subject has a CD19+ B-cell count ≥40 cells/μLaccording to the central laboratory at screening.
11.Receipt within the 3 months prior to Day 1:a.Tocilizumab (Actemra®)b.Belimumab (Benlysta®) c.Eculizumab (Soliris®)d.Cyclophosphamide (Cytoxan®)
12.Receipt within the 4 weeks prior to Day 1:a.Cyclosporine (except eye drops)b.Tacrolimus (except topical)c.Methotrexated.Intravenous immunoglobulin (IVIg)e.Plasma exchange(PLEX)treatment
13.Current use of: a.Prednisone > 40mg/day or > 80mg over a 2-day period (or equivalent dose of other corticosteroids)b.Pyridostigmine > 480 mg/day or unstable dose in the 2 weeks prior to Day 1c.Azathioprine > 3mg/kg/dayd.Mycophenolate mofetil > 3 g/day or mycophenolic acid > 1440 mg/day
14.Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 half-lives of the investigational treatment, whichever is longer, prior to Day 1.
15.Receipt ofa liveattenuated vaccine within 4 weeks prior to randomization. Administration of inactivated (killed) vaccines is acceptable.
16.History of severe allergic or anaphylactic reactions to biologic agents or known allergy to any component of the IPformulation.
17.History of recurrent significant infections(eg,requiring hospitalizationor IV antibiotics).
18.Within 2 weeks prior to the screening visit: clinically significant active infection requiring antimicrobialmedication but allowing chronic nail infections.
19.Unresected thymoma(Note: subjects with a benign thymoma resected >1 year prior to screening may enroll. Benign is defined as no known metastases and no extension into or beyond the capsule on pathological examination.Imaging to evaluate for thymoma must have been performed prior to randomization per standard of care).
20.History of cancer, exceptfor the following:a.In situ carcinoma of the cervix treated with apparent success with curative therapy for >12 months prior to screeningb.Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapyfor > 12 monthsprior to screeningc.Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent > 3 years prior to screening and without known recurrence or current treatmentd.Malignant thymoma resected >5 years prior to screening with no evidence of active disease and no therapy received over the previous 5 years.
21.Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks priorto screening.
22.Any of the following laboratory abnormalities at screening (one repeat test may be conducted to confirm results prior to randomization within the same screening period):a.Elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN)).b.Total bilirubin >1.5 ×ULN (unless due to Gilbert’s syndrome)c.Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2d.CD19+ B-cell count <40 cells/μL e.Absolute neutrophil count (ANC) <1.2 ×103cells/μlf.Platelet count < 75,000/μL (or < 75 × 109/L)g.Hemoglobin < 8.0 g/dLh.Total immunoglobulin < 600 mg/dL
23.Positive test for chronic hepatitis B infection at screening, defined as either (1) positive hepatitis B surface antigen (HBsAg) or (2)a positive hepatitis B core antibody (anti-HBc) PLUS negative hepatitis B surface antibody (anti-HBs). Note: Subjects with a positive anti-HBs only,or a positive anti-HBc plus positive anti-HBs andnegative HBsAg,are eligible to enroll.
24.Positive test for hepatitis C virus antibody.
25.Positive HIV test.
26.Blood transfusion within 4 weeks prior to screening or during the screening period.
27.Inability to read.
28.History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for tuberculosis was completed per local guidelines. Subjects with latent TB or a positive QuantiFERON®-TB Gold testwho are actively on anti-TB treatment can enroll if they have completed at least 1 month of anti-TB treatment and intend tocomplete the full course of anti-TB treatment. Subjects with an indeterminate QuantiFERON®-TB Gold test result can enroll if a repeat QuantiFERON®-TB Goldis negative or a tuberculin skin test is negative
If an individual meets any of the following criteria, he or she is ineligible for this study:
1.Any condition hat,in the opinion of the Investigator,would place the patient at unacceptable risk of complications,interfere with evaluation of the IP,or confound the interpretation of patient safety or study results.
2.Lactating or pregnant females, or females who intend to become pregnant anytime from signing the informed consent form (ICF)throughout the RCPplus 6 months following last dose of IP.
3.History of drug or alcohol abuse within <1 year prior to screening, or any condition associated with poor compliance as judged by the Investigator.
4.Employees of the Sponsor, contract research organization(CRO), site staff, and their family members.
5.Currently committed to an institution by way of official or judicial order.
6.Subjects diagnosed with congenital myasthenic syndromes.
7.Known immunodeficiency disorder, including human immunodeficiency virus (HIV) infection.
8.Thymectomy within ≤12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the RCP.
9.Receipt of the following medications or treatments at any time prior to randomization:a.Alemtuzumab (Lemtrada®, Campath®)b.Total lymphoid irradiationc.Bone marrow transplantd.T-cell vaccination therapye.Natalizumab (Tysabri®)
10.Receipt of rituximab (MabThera®, Rituxan®), ocrelizumab (Ocrevus®), ofatumumab (Arzerra®), obinutuzumab (Gazyva®), inebilizumab, or any experimental B-cell depleting agent within the 6 months prior to Day 1, unless the subject has a CD19+ B-cell count ≥40 cells/μLaccording to the central laboratory at screening.
11.Receipt within the 3 months prior to Day 1:a.Tocilizumab (Actemra®)b.Belimumab (Benlysta®) c.Eculizumab (Soliris®)d.Cyclophosphamide (Cytoxan®)
12.Receipt within the 4 weeks prior to Day 1:a.Cyclosporine (except eye drops)b.Tacrolimus (except topical)c.Methotrexated.Intravenous immunoglobulin (IVIg)e.Plasma exchange(PLEX)treatment
13.Current use of: a.Prednisone > 40mg/day or > 80mg over a 2-day period (or equivalent dose of other corticosteroids)b.Pyridostigmine > 480 mg/day or unstable dose in the 2 weeks prior to Day 1c.Azathioprine > 3mg/kg/dayd.Mycophenolate mofetil > 3 g/day or mycophenolic acid > 1440 mg/day
14.Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 half-lives of the investigational treatment, whichever is longer, prior to Day 1.
15.Receipt ofa liveattenuated vaccine within 4 weeks prior to randomization. Administration of inactivated (killed) vaccines is acceptable.
16.History of severe allergic or anaphylactic reactions to biologic agents or known allergy to any component of the IPformulation.
17.History of recurrent significant infections(eg,requiring hospitalizationor IV antibiotics).
18.Within 2 weeks prior to the screening visit: clinically significant active infection requiring antimicrobialmedication but allowing chronic nail infections.
19.Unresected thymoma(Note: subjects with a benign thymoma resected >1 year prior to screening may enroll. Benign is defined as no known metastases and no extension into or beyond the capsule on pathological examination.Imaging to evaluate for thymoma must have been performed prior to randomization per standard of care).
20.History of cancer, exceptfor the following:a.In situ carcinoma of the cervix treated with apparent success with curative therapy for >12 months prior to screeningb.Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapyfor > 12 monthsprior to screeningc.Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent > 3 years prior to screening and without known recurrence or current treatmentd.Malignant thymoma resected >5 years prior to screening with no evidence of active disease and no therapy received over the previous 5 years.
21.Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks priorto screening.
22.Any of the following laboratory abnormalities at screening (one repeat test may be conducted to confirm results prior to randomization within the same screening period):a.Elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN)).b.Total bilirubin >1.5 ×ULN (unless due to Gilbert’s syndrome)c.Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2d.CD19+ B-cell count <40 cells/μL e.Absolute neutrophil count (ANC) <1.2 ×103cells/μlf.Platelet count < 75,000/μL (or < 75 × 109/L)g.Hemoglobin < 8.0 g/dLh.Total immunoglobulin < 600 mg/dL
23.Positive test for chronic hepatitis B infection at screening, defined as either (1) positive hepatitis B surface antigen (HBsAg) or (2)a positive hepatitis B core antibody (anti-HBc) PLUS negative hepatitis B surface antibody (anti-HBs). Note: Subjects with a positive anti-HBs only,or a positive anti-HBc plus positive anti-HBs andnegative HBsAg,are eligible to enroll.
24.Positive test for hepatitis C virus antibody.
25.Positive HIV test.
26.Blood transfusion within 4 weeks prior to screening or during the screening period.
27.Inability to read.
28.History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for tuberculosis was completed per local guidelines. Subjects with latent TB or a positive QuantiFERON®-TB Gold testwho are actively on anti-TB treatment can enroll if they have completed at least 1 month of anti-TB treatment and intend tocomplete the full course of anti-TB treatment. Subjects with an indeterminate QuantiFERON®-TB Gold test result can enroll if a repeat QuantiFERON®-TB Goldis negative or a tuberculin skin test is negative
The Estimated Number of Participants
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Taiwan
24 participants
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Global
230 participants
