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Sponsor decision to terminate program
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This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics (PD), immunogenicity, and efficacy of subcutaneous (SC) ALXN1830 in adults with generalized myasthenia gravis (gMG).
Participants have the option to enroll in an Open-label Extension (OLE) Period to receive ALXN1830 up to 58 weeks (including follow-up period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALXN1830 Dosing Arm 1 | Experimental | Participants will receive ALXN1830. Treatment will be received for 16 weeks followed by an Observation Period (no treatment) for 8 weeks. |
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| ALXN1830 Dosing Arm 2 | Experimental | Participants will receive ALXN1830. Treatment will be received for 16 weeks followed by an Observation Period (no treatment) for 8 weeks. |
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| ALXN1830 Dosing Arm 3 | Experimental | Participants will receive placebo for 8 weeks, then ALXN1830 for 8 weeks, followed by an Observation Period (no treatment) for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1830 | Drug | Administered as an SC infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) And Serious Adverse Events (SAEs) Up To Week 24 | Up to Week 24 | |
| AEs And SAEs Up To Week 82 | Up to Week 82 (OLE) | |
| Change From Baseline In Serum Total Immunoglobulin G (IgG) | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Myasthenia Gravis Activities Of Daily Living Profile (MG-ADL) Total Score | Up to Week 24 | |
| Change From Baseline In Quantitative Myasthenia Gravis (QMG) Score | Up to Week 24 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | Phoenix | Arizona | 85028 | United States |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Placebo | Other | Administered as an SC infusion. |
|
| Number Of Participants With At Least A 2-point Improvement In The MG-ADL Score Over 4 Consecutive Weeks | Up to Week 24 |
| Number Of Participants With At Least A 3-point Improvement In The QMG Score Over 4 Consecutive Weeks | Up to Week 8 |
| Change From Baseline In Neurological Disorders Fatigue Questionnaire (Neuro-Qol) Fatigue Score | Up to Week 24 |
| Serum Trough Concentrations Of ALXN1830 | Up to Week 24 |
| Change From Baseline In IgG Subtypes | Up to Week 24 |
| Incidence Of Anti-drug Antibodies (ADA) And Neutralizing Antibodies (Nab) Against ALXN1830 | Up to Week 24 |
| Titers Of ADA And Nab Against ALXN1830 | Up to Week 24 |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |