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An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

NCT ID: NCT06540144

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2027-08-17

Brief Summary

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The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006.

Detailed Description

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Conditions

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Generalized Myasthenia Gravis

Keywords

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Generalized Myasthenia Gravis gMG rozanolixizumab pediatric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rozanolixizumab

Study participants will receive pre-defined doses of rozanolixizumab. Each treatment cycle in each Treatment Period (TP) consists of 6 subcutaneous (sc) administrations of rozanolixizumab at 1-week intervals. Each Treatment Period will be initiated upon the discretion of the Investigator based on the medical needs of the study-participant.

Group Type EXPERIMENTAL

rozanolixizumab

Intervention Type DRUG

rozanolixizumab solution for injection

Interventions

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rozanolixizumab

rozanolixizumab solution for injection

Intervention Type DRUG

Other Intervention Names

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UCB7665

Eligibility Criteria

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Inclusion Criteria

Study participant must meet one of the following:

* Study participant completed MG0006 according to the protocol
* Study participant completed the MG0006 Treatment Period and has a worsening of generalized myasthenia gravis (gMG) symptoms in the Observation Period of MG0006

Exclusion Criteria

* Study participant met any mandatory withdrawal or mandatory permanent investigational medicinal product (IMP) discontinuation criteria in MG0006 or permanently discontinued IMP
* Study participant has a known hypersensitivity to any components of the IMP or other neonatal Fc receptor (FcRn) drugs
* Study participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at Baseline, and could jeopardize or compromise the study participant's ability to participate in this study
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273

Locations

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Mg0008 40290

Bologna, , Italy

Site Status

Mg0008 40144

Milan, , Italy

Site Status

Mg0008 20340

Fuchu-shi, , Japan

Site Status

Mg0008 20339

Ōbu, , Japan

Site Status

Mg0008 20343

Sagamihara, , Japan

Site Status

Mg0008 40734

Lodz, , Poland

Site Status

Mg0008 40155

Warsaw, , Poland

Site Status

Mg0008 20081

Taipei, , Taiwan

Site Status

Mg0008 20095

Taipei, , Taiwan

Site Status

Countries

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Italy Japan Poland Taiwan

Other Identifiers

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2022-502075-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1286-3581

Identifier Type: OTHER

Identifier Source: secondary_id

MG0008

Identifier Type: -

Identifier Source: org_study_id