Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis

NCT ID: NCT04982289

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ALXN1830 Dosing Arm 1

Participants will receive ALXN1830. Treatment will be received for 16 weeks followed by an Observation Period (no treatment) for 8 weeks.

Group Type: EXPERIMENTAL

ALXN1830

Intervention Type: DRUG

Administered as an SC infusion.

ALXN1830 Dosing Arm 2

Participants will receive ALXN1830. Treatment will be received for 16 weeks followed by an Observation Period (no treatment) for 8 weeks.

Group Type: EXPERIMENTAL

ALXN1830

Intervention Type: DRUG

Administered as an SC infusion.

ALXN1830 Dosing Arm 3

Participants will receive placebo for 8 weeks, then ALXN1830 for 8 weeks, followed by an Observation Period (no treatment) for 8 weeks.

Group Type: EXPERIMENTAL

ALXN1830

Intervention Type: DRUG

Administered as an SC infusion.

Placebo

Intervention Type: OTHER

Administered as an SC infusion.

Interventions

ALXN1830

Administered as an SC infusion.

Intervention Type: DRUG

Placebo

Administered as an SC infusion.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of myasthenia gravis.
• Positive serologic test for anti-acetylcholine receptor antibodies.
• Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at Screening.
• MG-ADL profile must be ≥ 5.
• Participants receiving stable treatment with azathioprine; other immunosuppressive therapies.
• Total IgG level at Screening ≥ 600 milligrams/deciliter.

Exclusion Criteria

• History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to Screening.
• Any untreated thymic malignancy, carcinoma, or thymoma.
• Intravenous immunoglobulin within the 6 weeks, and/or use of plasmapheresis/plasma exchange prior to randomization (Day 1).
• Use of rituximab within the 3 months (90 days) prior to Screening.
• Participants who have received previous treatment with any biological agent or other anti-neonatal fragment crystallizable receptor therapy within 5 half-lives or 90 days after last dose (whichever is longer).
• Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Study Site

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

ALXN1830-MG-201

Identifier Type: -

Identifier Source: org_study_id