A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Completed · Phase 3

Conditions studied: Generalized Myasthenia Gravis

In brief

The purpose of the MycarinGstudy is to evaluate the long-term safety, tolerability and long-term efficacy of rozanolixizumab in study participants with generalized myasthenia gravis (MG).

Key facts

Study ID: NCT04124965
Run by: UCB Biopharma SRL
People needed: 71
Starts: 2019-10-29
Expected to finish: 2021-09-01
Last updated by the study team: 2023-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 anti-neonatal 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 Columbia-Suicide Severity Rating Scale (C-SSRS)

Where it is running

Mg0004 50081 — Phoenix, Arizona, United States
Mg0004 50072 — Los Angeles, California, United States
Mg0004 50088 — Washington D.C., District of Columbia, United States
Mg0004 50120 — Miami, Florida, United States
Mg0004 50073 — Tampa, Florida, United States
Mg0004 50114 — Indianapolis, Indiana, United States
Mg0004 50121 — Lexington, Kentucky, United States
Mg0004 50077 — New York, New York, United States
Mg0004 50090 — Winston-Salem, North Carolina, United States
Mg0004 50096 — Philadelphia, Pennsylvania, United States
Mg0004 50066 — Montreal, Canada
Mg0004 50070 — Québec, Canada
Mg0004 50069 — Toronto, Canada
Mg0004 40125 — Ostrava-Poruba, Czechia
Mg0004 40124 — Prague, Czechia
Mg0004 40128 — Aalborg, Denmark
Mg0004 40129 — Bordeaux, France
Mg0004 40132 — Nice, France
Mg0004 40133 — Paris, France
Mg0004 40131 — Strasbourg, France
Mg0004 40140 — Göttingen, Germany
Mg0004 40078 — Leipzig, Germany
Mg0004 40177 — Münster, Germany
Mg0004 40144 — Milan, Italy
Mg0004 40146 — Pavia, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.