A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

December 5, 2025 updated by: UCB Biopharma SRL

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Mg0003 40121
  • Canada
      • Calgary, Canada
        • Mg0003 50067
      • Montreal, Canada
        • Mg0003 50066
      • Québec, Canada
        • Mg0003 50070
      • Toronto, Canada
        • Mg0003 50069
  • Czechia
      • Ostrava, Czechia
        • Mg0003 40125
      • Prague, Czechia
        • Mg0003 40124
  • Denmark
      • Aalborg, Denmark
        • Mg0003 40128
      • Aarhus N, Denmark
        • Mg0003 40127
      • Copenhagen, Denmark
        • Mg0003 40126
      • Odense, Denmark
        • Mg0003 40489
  • France
      • Bordeaux, France
        • Mg0003 40129
      • Clermont-Ferrand, France
        • Mg0003 40070
      • Garches, France
        • Mg0003 40512
      • Le Kremlin-Bicêtre, France
        • Mg0003 40510
      • Limoges, France
        • Mg0003 40360
      • Lyon, France
        • Mg0003 40426
      • Marseille, France
        • Mg0003 40130
      • Nantes, France
        • Mg0003 40017
      • Nice, France
        • Mg0003 40132
      • Paris, France
        • Mg0003 40133
      • Strasbourg, France
        • Mg0003 40131
  • Georgia
      • Tbilisi, Georgia
        • Mg0003 20160
      • Tbilisi, Georgia
        • Mg0003 20161
      • Tbilisi, Georgia
        • Mg0003 20163
      • Tbilisi, Georgia
        • Mg0003 20165
  • Germany
      • Essen, Germany
        • Mg0003 40134
      • Gummersbach, Germany
        • Mg0003 40135
      • Göttingen, Germany
        • Mg0003 40140
      • Jena, Germany
        • Mg0003 40139
      • Leipzig, Germany
        • Mg0003 40078
      • Münster, Germany
        • Mg0003 40177
  • Hungary
      • Kistarcsa, Hungary
        • Mg0003 40082
      • Nyíregyháza, Hungary
        • Mg0003 40178
  • Italy
      • Bologna, Italy
        • Mg0003 40283
      • Lazio, Italy
        • Mg0003 40149
      • Milan, Italy
        • Mg0003 40144
      • Napoli, Italy
        • Mg0003 40307
      • Pavia, Italy
        • Mg0003 40146
      • Roma, Italy
        • Mg0003 40148
      • Roma, Italy
        • Mg0003 40150
  • Japan
      • Bunkyō City, Japan
        • Mg0003 20035
      • Chiba, Japan
        • Mg0003 20068
      • Hanamaki-Shi, Japan
        • Mg0003 20078
      • Hiroshima, Japan
        • Mg0003 20079
      • Kobe, Japan
        • Mg0003 20075
      • Nagasaki, Japan
        • Mg0003 20071
      • Sapporo, Japan
        • Mg0003 20067
      • Sendai, Japan
        • Mg0003 20077
      • Shinjuku-Ku, Japan
        • Mg0003 20070
      • Shinjuku-Ku, Japan
        • Mg0003 20076
      • Suita, Japan
        • Mg0003 20032
      • Ōsaka-sayama, Japan
        • Mg0003 20074
  • Poland
      • Gdansk, Poland
        • Mg0003 40155
      • Lodz, Poland
        • Mg0003 40154
      • Lublin, Poland
        • Mg0003 40151
      • Poznan, Poland
        • Mg0003 40153
  • Russia
      • Krasnoyarsk, Russia
        • Mg0003 20168
      • Moscow, Russia
        • Mg0003 20027
      • Novosibirsk, Russia
        • Mg0003 20169
      • Saint Petersburg, Russia
        • Mg0003 20001
      • Saint Petersburg, Russia
        • Mg0003 20028
      • Saint Petersburg, Russia
        • Mg0003 20029
      • Saint Petersburg, Russia
        • Mg0003 20055
      • Samara, Russia
        • Mg0003 20197
  • Serbia
      • Belgrade, Serbia
        • Mg0003 40468
      • Niš, Serbia
        • Mg0003 40467
  • Spain
      • Barcelona, Spain
        • Mg0003 40159
      • Barcelona, Spain
        • Mg0003 40160
      • Barcelona, Spain
        • Mg0003 40267
      • L'Hospitalet de Llobregat, Spain
        • Mg0003 40157
      • Madrid, Spain
        • Mg0003 40161
      • Madrid, Spain
        • Mg0003 40162
      • Murcia, Spain
        • Mg0003 40350
      • Málaga, Spain
        • Mg0003 40341
      • San Sebastián de los Reyes, Spain
        • Mg0003 40308
  • Taiwan
      • Taichung, Taiwan
        • Mg0003 20080
      • Taipei, Taiwan
        • Mg0003 20081
      • Taipei, Taiwan
        • Mg0003 20086
      • Taoyuan District, Taiwan
        • Mg0003 20082
  • United Kingdom
      • London, United Kingdom
        • Mg0003 40175
      • Nottingham, United Kingdom
        • Mg0003 40168
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Mg0003 50081
      • Scottsdale, Arizona, United States, 85251
        • Mg0003 50082
    • California
      • Los Angeles, California, United States, 90033
        • Mg0003 50072
      • Orange, California, United States, 92868
        • Mg0003 50092
      • San Francisco, California, United States, 94117
        • Mg0003 50099
      • San Francisco, California, United States, 94109
        • Mg0003 50097
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Mg0003 50101
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Mg0003 50088
    • Florida
      • Miami, Florida, United States, 33136
        • Mg0003 50122
      • Miami, Florida, United States, 33144
        • Mg0003 50120
      • Tampa, Florida, United States, 33612
        • Mg0003 50073
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Mg0003 50075
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Mg0003 50323
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Mg0003 50109
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Mg0003 50114
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Mg0003 50074
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Mg0003 50121
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Mg0003 50110
      • Detroit, Michigan, United States, 48202
        • Mg0003 50102
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mg0003 50104
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Mg0003 50105
    • New York
      • New York, New York, United States, 10021
        • Mg0003 50077
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Mg0003 50117
      • Charlotte, North Carolina, United States, 28207
        • Mg0003 50086
      • Winston-Salem, North Carolina, United States, 27157
        • Mg0003 50090
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Mg0003 50076
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Mg0003 50096
      • Philadelphia, Pennsylvania, United States, 19140
        • Mg0003 50089
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Mg0003 50084
    • Texas
      • Houston, Texas, United States, 77030
        • Mg0003 50113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Study participant must be ≥18 years of age, at the time of signing the informed consent
  • Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations
  • Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at Screening (Visit 1).The presence of autoantibodies may be confirmed with repeat testing at Visit 1
  • Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1
  • Study participant with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 3 (with ≥3 points from non-ocular symptom) AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline (Visit 2)
  • Study participant is considered for additional treatment such as intravenous immunoglobulin g (IVIg) or plasma exchange (PEX) by the Investigator

Exclusion Criteria:

  • Study participant has a known history of hyperprolinemia
  • Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
  • 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) will be excluded
  • 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-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis at Visit 1 or Visit 2
  • Study participant has a history of a solid organ transplant or hematopoietic stem cell/marrow transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dosage Regimen 1
Study participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.
Drug: Rozanolixizumab
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Other Names:
  • UCB7665
Experimental: Dosage Regimen 2
Study participants randomized to dosage regimen 2 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.
Drug: Rozanolixizumab
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Other Names:
  • UCB7665
Placebo Comparator: Placebo
Study participants randomized to this arm will receive placebo.
Other: Placebo
Subjects will receive placebo at pre-specified time points.
Other Names:
  • PBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
Time Frame: Baseline and Day 43
The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (PRO) instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement.
Baseline and Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43
Time Frame: Day 43
The MG-ADL is an 8-item PRO instrument developed on the basis of the QMG. The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement. Study participants were classified as responders at Day 43 if the value was at least a 2-point improvement (decrease) from Baseline at Day 43.
Day 43
Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score
Time Frame: Baseline and Day 43
MG-C scale is a validated assessment and scale tests 10 items with individual item being weighted differently. The items included ptosis/upward gaze (range: 0 [>45 second] - 3 [Immediate]), double vision on lateral gaze (range: 0 [>45 second] - 4 [Immediate]), eye closure (range: 0 [Normal] - 2 [severe weakness]), talking (range: 0 [Normal] - 6 [difficult to understand speech]), chewing (range: 0 [Normal] - 6 [gastric tube]), swallowing (range: 0 [Normal] - 6 [gastric tube]), breathing (range: 0 [Normal] - 9 [ventilator dependence]), neck flexion (range: 0 [Normal] - 4 [severe weakness]), shoulder abduction (range: 0 [Normal] - 5 [severe weakness]) and hip flexion (range: 0 [Normal] - 5 [severe weakness]), lower scores= lower disease activity. Total MG-C score was obtained by summing responses to each individual item and score ranges from 0 to 50, with lower scores indicating lower disease activity. A positive change indicates worsening and a negative change indicates improvement.
Baseline and Day 43
Change From Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) Total Score
Time Frame: Baseline and Day 43
The QMG is a validated assessment and the scale tested 13 items, including ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3) and the score ranges from 0 to 39, with lower scores indicating lower disease activity. A positive change in the score indicates worsening and a negative change indicates improvement.
Baseline and Day 43
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score
Time Frame: Baseline and Day 43
MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that how frequently they experienced muscle weakness fatigability (items 34-42) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Baseline and Day 43
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Physical Fatigue' Score
Time Frame: Baseline and Day 43
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose the response option that how frequently they experienced physical fatigue (items 19-33) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Baseline and Day 43
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Bulbar Symptoms' Score
Time Frame: Baseline and Day 43
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that best described severity of bulbar muscle weakness (items 6-15) symptoms over past 7 days using a 4-point Likert scale (1="none" to 4="severe") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Baseline and Day 43
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From Baseline until End of Study Visit (up to Week 14)
A TEAE is defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) up to and including 8 weeks after the last dose.
From Baseline until End of Study Visit (up to Week 14)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Investigational Medicinal Product (IMP)
Time Frame: From Baseline until End of Study Visit (up to Week 14)
A TEAE is defined as an AE starting on or after the time of first administration of IMP up to and including 8 weeks after the last dose.
From Baseline until End of Study Visit (up to Week 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, +1 844 599 2273 (UCB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2019

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

October 26, 2021

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Estimated)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG0003
  • 2019-000968-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

IPD Sharing Time Frame

Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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