Health TrialsbyHealthPanel

Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)

ConditionsGeneralized Myasthenia GravisgMG
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAlexion Pharmaceuticals, Inc.

About this trial

The primary purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adult participants with Acetylcholine receptor (AChR) + Generalized Myasthenia Gravis (gMG).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed generalized MG: Diagnosis ≥6 months before screening, anti-AChR antibody positive, and supportive diagnostic evidence (e.g., abnormal SFEMG/RNS or response to anticholinesterase therapy).

Disease severity: MGFA Class II-IV at screening.

Symptoms threshold: MG-ADL ≥6 at screening and on Day 1.

Meningococcal vaccination: Up to date within 3 years or vaccinated before first dose to mitigate risk with complement inhibition.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Ravulizumab

    Drug

    Participants will receive ravulizumab via intravenous (IV) infusion.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: RavulizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Total Score at Week 26

Time frame
Baseline, Week 26

Secondary outcomes

1

Change From Baseline in Quantitative Myasthenia gravis (QMG) Total Score at Week 26

Time frame
Baseline, Week 26
2

Number of Participants With Reduction by >=5 Points From Baseline in QMG Total Score at Week 26

Time frame
Baseline up to Week 26
3

Number of Participants With Reduction by >=3 Points From Baseline in MG-ADL Total Score at Week 26

Time frame
Baseline up to Week 26
4

Change From Baseline in Revised Myasthenia Gravis Quality of Life 15-Item Scale (MG-QoL15r) Total Score at Week 26

Time frame
Baseline, Week 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexion Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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