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

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

NCT ID: NCT06540144

Condition: Generalized Myasthenia Gravis

Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Rozanolixizumab

Conditions: Keywords:
Generalized Myasthenia Gravis
gMG
rozanolixizumab
pediatric

Study type: Interventional

Study phase: Phase 3

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: rozanolixizumab
Description: rozanolixizumab solution for injection
Arm group label: rozanolixizumab

Other name: UCB7665

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 2 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mg0008 40290

Address:
City: Bologna
Country: Italy

Facility:
Name: Mg0008 40734

Address:
City: Lodz
Country: Poland

Start date: October 8, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: UCB Biopharma SRL
Agency class: Industry

Source: UCB Pharma

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06540144