NCT04982289

Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis

A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALXN1830 Administered Subcutaneously in Adult Patients With Generalized Myasthenia Gravis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Participants have the option to enroll in an Open-label Extension (OLE) Period to receive ALXN1830 up to 58 weeks (including follow-up period).

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	ALXN1830	Administered as an SC infusion.
OTHER	Placebo	Administered as an SC infusion.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-01-31
• Completion: 2024-01-31
• First posted: 2021-07-29
• Last updated: 2022-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study