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Clinical Trials/EUCTR2019-000969-21-CZ
EUCTR2019-000969-21-CZActive, not recruitingPhase 1

A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy

CB Biopharma SR0 sites276 target enrollmentStarted: December 20, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
276
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- Participant was eligible for MG0003 [NCT03971422] or MGC003 at the time of enrollment into either study and the participant either completed the Observation Period of MG0003 or MGC003 or required rescue therapy during the Observation Period of the lead-in studies
  • •- Body weight =35 kg at Visit 1
  • •- Study participants may be male or female
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 248
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

  • •- 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
  • •- Participant has received a live vaccination within 8 weeks prior to the Baseline visit; or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of study medication
  • •- Study participant has experienced hypersensitivity reaction after exposure to other antineonatal Fc receptor (FcRn) drugs
  • •- Study participant with severe (defined as Grade 3 on the myasthenia gravis-activates of daily living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis
  • •- Participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at randomization, and could jeopardize or compromise the study participant’s ability to participate in this study
  • •- Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria MG0003 [NCT03971422] or MGC003 or discontinued study medication in either study, with the exception of discontinuation due to a need for rescue treatment
  • •- Study participant is not considered capable of adhering to the protocol visit schedule, or medication intake according to the judgment of the Investigator
  • •- Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or had suicidal ideation since the last visit in MG0003 as indicated by a positive response (Yes) to either Question 4 or Question 5 of the ColumbiaSuicide Severity Rating Scale (C-SSRS)

Investigators

Sponsor
CB Biopharma SR

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