CompletedPhase 3

A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

United States165 participantsStarted 2021-02-03

Plain-language summary

The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. completed MG0003 \[NCT03971422\]
✓. required rescue therapy during the Observation Period in MG0003 or
✓. completed at least 6 visits in MG0004 \[NCT04124965\]

What they're measuring

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: From Baseline (Day 1) to End of Study (up to 34 months)

Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (IMP)

Timeframe: From Baseline (Day 1) to End of Study (up to 34 months)

Trial details

NCT IDNCT04650854

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-25

Results submitted2025-01-22

View on ClinicalTrials.gov More Generalized Myasthenia Gravis trials