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

Recruiting in Palo Alto (17 mi)

+114 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: UCB Biopharma SRL

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Research Team

UCB Cares

Principal Investigator

+1 844 599 2273 (UCB)

Eligibility Criteria

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

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Treatment Details

Interventions

Rozanolixizumab (Monoclonal Antibodies)

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Dosage Regimen 2Experimental Treatment1 Intervention

Study participants randomized to dosage regimen 2 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.

Group II: Dosage Regimen 1Experimental Treatment1 Intervention

Study participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.

Group III: PlaceboPlacebo Group1 Intervention

Study participants randomized to this arm will receive placebo.

Rozanolixizumab is already approved in United States, European Union, Japan for the following indications:

🇺🇸 Approved in United States as Rystiggo for:

Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

🇪🇺 Approved in European Union as Rystiggo for:

Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

🇯🇵 Approved in Japan as Rystiggo for:

Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive