A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

NCT ID: NCT05681715

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2024-04-23

Brief Summary

The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.

Conditions

Generalized Myasthenia Gravis

Keywords

generalized Myasthenia Gravis; gMG; rozanolixizumab

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rozanolixizumab Sequence 1: Syringe Driver - Manual Push

Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

Rozanolixizumab self-administration via Syringe Driver or Manual Push.

Rozanolixizumab Sequence 2: Manual Push - Syringe Driver

Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

Rozanolixizumab self-administration via Syringe Driver or Manual Push.

Interventions

Rozanolixizumab

Rozanolixizumab self-administration via Syringe Driver or Manual Push.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG)
• Study participant is willing to perform and capable of performing home self-administration
• Study participant is considered by the investigator for additional rozanolixizumab treatment with the posology proposed in this study.
• Body weight ≥35 kg
• Study participants may be male or female

Exclusion Criteria

• Study participant has a known hypersensitivity to other anti-Fc receptor (FcRn) medications, to any components of the study medication, to any of the excipients (including polysorbate 80), or has a known history of hyperprolinemia, since both polysorbate 80 and L-proline are constituents of the rozanolixizumab formulation
• Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current or history of nontuberculous mycobacterial infection (NTMBI)
• Study participant has a clinically relevant active infection or a history of serious infection (resulting in hospitalization or requiring IV antibiotic treatment) within 6 weeks before the Baseline Visit
• The study participant previously participated in any rozanolixizumab MG study and met any mandatory withdrawal criteria (unless the reason is directly related to MG0020 participation) or mandatory study drug discontinuation criteria.
• Study participant has received a live vaccination within 4 weeks before starting treatment, or a Bacillus Calmette-Guérin (BCG) vaccine within 1 year before starting treatment; or intends to have a live vaccination during the course of the study or within 8 weeks following the last dose of rozanolixizumab
• Study participant with severe (defined as Grade 3 on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis

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

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273

Locations

Mg0020 50092

Orange, California, United States

Mg0020 50099

San Francisco, California, United States

Mg0020 50561

Lexington, Kentucky, United States

Mg0020 50090

Winston-Salem, North Carolina, United States

Mg0020 50560

Edmonton, , Canada

Mg0020 50069

Toronto, , Canada

Mg0020 20161

Tbilisi, , Georgia

Mg0020 20165

Tbilisi, , Georgia

Mg0020 20305

Tbilisi, , Georgia

Mg0020 40140

Göttingen, , Germany

Mg0020 40177

Münster, , Germany

Mg0020 40144

Milan, , Italy

Mg0020 40146

Pavia, , Italy

Mg0020 40150

Roma, , Italy

Mg0020 20068

Chiba, , Japan

Mg0020 20078

Hanamaki-shi, , Japan

Mg0020 20077

Sendai, , Japan

Mg0020 20076

Shinjuku-ku, , Japan

Mg0020 40155

Gdansk, , Poland

Mg0020 40727

Lodz, , Poland

Mg0020 40153

Poznan, , Poland

Mg0020 40729

Niš, , Serbia

Mg0020 40160

Barcelona, , Spain

Mg0020 40267

Barcelona, , Spain

Mg0020 40308

San Sebastián de los Reyes, , Spain

Mg0020 40168

Nottingham, , United Kingdom

Mg0020 40163

Oxford, , United Kingdom

Countries

United States; Canada; Georgia; Germany; Italy; Japan; Poland; Serbia; Spain; United Kingdom

References

Bril V, Antozzi C, Berkowicz T, Druzdz A, Gandhi Mehta RK, Mahuwala ZK, Zschuntzsch J, Boehnlein M, Kerbusch V, Lavrov A, Morris M, Singh P, Leite MI. Self-administration of rozanolixizumab via manual push and infusion pump methods in patients with generalised myasthenia gravis: a randomised, phase 3, open-label, crossover study. J Neurol. 2025 Oct 11;272(10):686. doi: 10.1007/s00415-025-13420-6.

Reference Type: RESULT

PMID: 41074934 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-003870-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MG0020

Identifier Type: -

Identifier Source: org_study_id