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OLE of Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

Ali A Habib


A Study On:

  • Myasthenia Gravis

Status:

  • Open

Eligibility

18 Years and older (Adult, Older Adult)

Interested in joining this trial?

Official Title

An Open-Labe Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

Details

Enrollment is by Invitation Only.


Eligibility

You can join if...

Inclusion Criteria:

  1. Study participant must meet one of the following: completed MG0003 [NCT03971422] or MGC003, required rescue therapy during the Observation Period in MG0003, or completed at least 6 visits in MG0004 [NCT04124965]
  2. Body weight greater than or equal to 35 kg at Baseline (Day 1).
  3. Study participants may be male or female

Exclusion Criteria:

  1. Study participant has a known hypersensitivity to any components of the study medication
  2. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, if applicable, chest x-rays (posterior anterior and lateral), and TB testing by a positive (not indeterminate) QuantiFERON®-TB Gold Plus
  3. Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, MGC003, or MG0004, or permanently discontinued study drug in either study
  4. Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of rozanolixizumab
  5. 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

Get in touch with our study team