18 and older, any sex, with Refractory Generalized Myasthenia Gravis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Count Of Participants With Treatment-Emergent Adverse EventsPrimary· Day 1 (after dosing) through End of Study (Week 208)
Treatment-emergent adverse events (TEAEs) are adverse events with onset on or after the first study drug dose in Study ECU-MG-302. Likewise, treatment-emergent serious adverse events (TESAEs) are serious adverse events that onset on or after the first study drug dose in Study ECU-MG-302. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
TEAEs
Group
Value
95% CI
Eculizumab/Eculizumab
55
Placebo/Eculizumab
59
TEAEs leading to withdrawal
Group
Value
95% CI
Eculizumab/Eculizumab
3
Placebo/Eculizumab
5
TESAEs
Group
Value
95% CI
Eculizumab/Eculizumab
30
Placebo/Eculizumab
30
TESAEs leading to withdrawal
Group
Value
95% CI
Eculizumab/Eculizumab
3
Placebo/Eculizumab
4
Deaths
Group
Value
95% CI
Eculizumab/Eculizumab
2
Placebo/Eculizumab
1
Change From Baseline In Myasthenia Gravis Activities Of Daily Living Profile (MG-ADL) Total Score At Week 4 And Week 130Secondary· Baseline, Week 4 and Week 130
The MG-ADL scale is a validated 8-item patient-reported outcome measure. Participants assessed their functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb impairment (2 items). These 8 items were not weighted and were individually graded from 0 (normal) to 3 (most severe), providing a total MG-ADL score ranging from 0 to 24 points. A reduction in score indicates improvement in condition. Baseline was defined as the last available assessment prior to treatment (first study drug infusion) with eculizumab in Study ECU-MG-302. Change f
Change from Baseline At Week 4 (Blind Induction)
Group
Value
95% CI
Eculizumab/Eculizumab
-0.2
± 1.77
Placebo/Eculizumab
-2.4
± 3.04
Change from Baseline at Week 130 (Open-label)
Group
Value
95% CI
Eculizumab/Eculizumab
-0.7
± 4.19
Placebo/Eculizumab
-3.9
± 3.68
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 after dosing of study drug through Week 208..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Eculizumab/Eculizumab
Serious: 30/56 (54%)
Deaths: 2/56
Placebo/Eculizumab
Serious: 30/61 (49%)
Deaths: 1/61
Eculizumab (Combined Total)
Serious: 60/117 (51%)
Deaths: 3/117
Serious adverse events (105 terms)
Reaction
System
Eculizumab/Eculizumab
Placebo/Eculizumab
Eculizumab (Combined Total)
Myasthenia gravis
Nervous system disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Myasthenia gravis crisis
Nervous system disorders
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
Pyrexia
General disorders
—
—
—
Gastroenteritis
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Headache
Nervous system disorders
—
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
Bronchitis
Infections and infestations
—
—
—
Influenza
Infections and infestations
—
—
—
Localised infection
Infections and infestations
—
—
—
Upper respiratory tract infection
Infections and infestations
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Humerus fracture
Injury, poisoning and procedural complications
—
—
—
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-301(NCT01997229).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06764160 — Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG
· Phase 3
· completed
NCT06513338 — Complement C5 mAb in the Treatment of Anti-GBM Disease
· Phase 2
· completed
NCT05876351 — Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China
· Phase 3
· completed
NCT05886244 — Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
· Phase 3
· completed
NCT05131204 — Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment
· Phase 3
· terminated
Other Alexion Pharmaceuticals, Inc. trials
Trials by the same sponsor.
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· Phase 4
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· Phase 1
· recruiting
NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
· Phase 4
· recruiting
NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o
· active not recruiting
NCT07308574 — Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS
· Phase 4
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc.
Last refreshed: 5 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02301624.