A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

UCB

Status and phase: Completed; Phase 3

Conditions: Generalized Myasthenia Gravis

Treatments: Drug: Rozanolixizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04650854

MG0007

2020-003230-20 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Study participant must meet one of the following:

  1. completed MG0003 [NCT03971422]
  2. required rescue therapy during the Observation Period in MG0003 or
  3. completed at least 6 visits in MG0004 [NCT04124965]

• Body weight ≥35 kg at Baseline (Day 1)

• Study participants may be male or female

Exclusion criteria

• Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications
• Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
• Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, or MG0004, or permanently discontinued study drug in either study
• Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

Rozanolixizumab dosage regimen 1

Experimental group

Description:

Study participants randomized/assigned to dosage regimen 1 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.

Treatment:

Drug: Rozanolixizumab

Rozanolixizumab dosage regimen 2

Experimental group

Description:

Study participants randomized/assigned to dosage regimen 2 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.

Treatment:

Drug: Rozanolixizumab