Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis

Generalized Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04982289
• Other study ID #: ALXN1830-MG-201
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2022
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Key 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.

Related Conditions & MeSH terms

• Generalized Myasthenia Gravis
• Muscle Weakness
• Myasthenia Gravis

Intervention

Drug:
• ALXN1830
Administered as an SC infusion.

Other:
• Placebo
Administered as an SC infusion.

Locations

Country	Name	City	State
United States	Clinical Study Site	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs) And Serious Adverse Events (SAEs) Up To Week 24		Up to Week 24
Primary	AEs And SAEs Up To Week 82		Up to Week 82 (OLE)
Primary	Change From Baseline In Serum Total Immunoglobulin G (IgG)		Up to Week 24
Secondary	Change From Baseline In Myasthenia Gravis Activities Of Daily Living Profile (MG-ADL) Total Score		Up to Week 24
Secondary	Change From Baseline In Quantitative Myasthenia Gravis (QMG) Score		Up to Week 24
Secondary	Number Of Participants With At Least A 2-point Improvement In The MG-ADL Score Over 4 Consecutive Weeks		Up to Week 24
Secondary	Number Of Participants With At Least A 3-point Improvement In The QMG Score Over 4 Consecutive Weeks		Up to Week 8
Secondary	Change From Baseline In Neurological Disorders Fatigue Questionnaire (Neuro-Qol) Fatigue Score		Up to Week 24
Secondary	Serum Trough Concentrations Of ALXN1830		Up to Week 24
Secondary	Change From Baseline In IgG Subtypes		Up to Week 24
Secondary	Incidence Of Anti-drug Antibodies (ADA) And Neutralizing Antibodies (Nab) Against ALXN1830		Up to Week 24
Secondary	Titers Of ADA And Nab Against ALXN1830		Up to Week 24