By InvitationPhase 3

An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

Italy, Japan12 participantsStarted 2024-10-08

Plain-language summary

The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006.

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Study participant must meet one of the following: * Study participant completed MG0006 according to the protocol * Study participant completed the MG0006 Treatment Period and has a worsening of generalized myasthenia gravis (gMG) symptoms in the Observation Period of MG0006 Exclusion Criteria: * Study participant met any mandatory withdrawal or mandatory permanent investigational medicinal product (IMP) discontinuation criteria in MG0006 or permanently discontinued IMP * Study participant has a known hypersensitivity to any components of the IMP or other neonatal Fc receptor (FcRn) drugs * Study participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at Baseline, and could jeopardize or compromise the study participant's ability to participate in this study

What they're measuring

Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit

Timeframe: From Baseline up to the EOS Visit (up to 52 weeks)

Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit

Timeframe: From Baseline up to the EOS Visit (up to 52 weeks)

Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit

Timeframe: From Baseline up to the EOS Visit (up to 52 weeks)

Trial details

NCT IDNCT06540144

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-17

View on ClinicalTrials.gov More Generalized Myasthenia Gravis trials

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit

Timeframe: From Baseline up to the EOS Visit (up to 52 weeks)

Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit

Timeframe: From Baseline up to the EOS Visit (up to 52 weeks)

Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit

Timeframe: From Baseline up to the EOS Visit (up to 52 weeks)