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

NCT ID: NCT04124965

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-29
• Study Completion Date: 2021-09-01

Brief Summary

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).

Conditions

Generalized Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rozanolixizumab dosage regimen 1

Study participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during the Treatment Period. The dose regimen may be switched based on investigator discretion.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.

Rozanolixizumab dosage regimen 2

Study participants randomized to dosage regimen 2 will receive assigned dosage of rozanolixizumab at pre-specified time points during the Treatment Period. The dose regimen may be switched based on investigator discretion.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.

Interventions

Rozanolixizumab

Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.

Intervention Type: DRUG

Other Intervention Names

UCB7665

Eligibility Criteria

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

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 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 22733 (UCB)

Locations

Mg0004 40129

Bordeaux, , France

Mg0004 40132

Nice, , France

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 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

Mg0004 40148

Roma, , Italy

Mg0004 40150

Roma, , Italy

Mg0004 20078

Hanamaki Shi, , Japan

Mg0004 20079

Hiroshima, , Japan

Mg0004 20077

Miyagi, , Japan

Mg0004 20076

Shinjuku-Ku, , Japan

Mg0004 20032

Suita, , Japan

Mg0004 40155

Gdansk, , Poland

Mg0004 40154

Lodz, , Poland

Mg0004 40151

Lublin, , Poland

Mg0004 20027

Moscow, , Russia

Mg0004 20001

Saint Petersburg, , Russia

Mg0004 20028

Saint Petersburg, , Russia

Mg0004 20055

Saint Petersburg, , Russia

Mg0004 40159

Barcelona, , Spain

Mg0004 40157

L'Hospitalet de Llobregat, , Spain

Mg0004 20080

Taichung, , Taiwan

Mg0004 20081

Taipei, , Taiwan

Countries

United States; Canada; Czechia; Denmark; France; Germany; Italy; Japan; Poland; Russia; Spain; Taiwan

References

Bril V, Druzdz A, Grosskreutz J, Habib AA, Kaminski HJ, Mantegazza R, Sacconi S, Utsugisawa K, Vu T, Boehnlein M, Gayfieva M, Greve B, Woltering F, Vissing J; MG0004 study investigators. Safety and efficacy of chronic weekly rozanolixizumab in generalized myasthenia gravis: the randomized open-label extension MG0004 study. J Neurol. 2025 Mar 19;272(4):275. doi: 10.1007/s00415-025-12958-9.

Reference Type: DERIVED

PMID: 40105996 (View on PubMed)

Bril V, Druzdz A, Grosskreutz J, Habib AA, Mantegazza R, Sacconi S, Utsugisawa K, Vissing J, Vu T, Boehnlein M, Bozorg A, Gayfieva M, Greve B, Woltering F, Kaminski HJ; MG0003 study team. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023 May;22(5):383-394. doi: 10.1016/S1474-4422(23)00077-7.

Reference Type: DERIVED

PMID: 37059507 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-000969-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MG0004

Identifier Type: -

Identifier Source: org_study_id