CompletedPhase 3

Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG

China15 participantsStarted 2025-01-06

Plain-language summary

This is an open-label, single-arm, multi-center study to evaluate the efficacy, safety, PK, PD, and immunogenicity of eculizumab in Chinese participants with refractory gMG. Approximately 15 participants will be enrolled in the study.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Positive serologic test for anti-AChR Abs as confirmed at Screening, and
✓. One of the following:
✓. Abnormal neuromuscular transmission demonstrated by repetitive nerve stimulation, or
✓. History of positive anticholinesterase test, eg, neostigmine test, or
✓. Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician
✓. Failed treatment with 2 or more ISTs over one year (either in combination or as monotherapy), ie, continue to have impairment ADLs (persistent weakness, experience crisis, or unable to tolerate IST) despite ISTs or,
✓. Failed at least one IST and require chronic PE or IVIg to control symptoms, ie, participants who require PE or IVIg on a regular basis for the management of muscle weakness at least 2 cycles over last 12 months

Exclusion criteria

✕. Treatment completed \> 5 years prior to the Screening Visit
✕. No recurrence within the 5 years prior to the Screening Visit
✕. No radiological indication of recurrence in a computed tomography (CT) or magnetic resonance imaging (MRI) scan, including administration of intravenous (IV) contrast, performed within 6 months of first dose on Day 1

What they're measuring

To assess the efficacy of eculizumab in the treatment of refractory gMG based on the improvement in the MG-ADL

Timeframe: from baseline at Week 26

Trial details

NCT IDNCT06764160

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-29

View on ClinicalTrials.gov More Generalized Myasthenia Gravis (gMG) trials