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An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis (MG0007)

A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis

SUGIHARA Kazuhiro

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo

CTR-JRCT.UCBJapan@ucb.com

Global Clinical Science & Operation

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023

+81-3-6864-7587

CTR_SCC_UCBJapan@UCB.com

Not Recruiting

Feb. 09, 2021

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

- Study participant must meet one of the following:
a) completed MG0003 [NCT03971422]
b) required rescue therapy during the Observation Period in MG0003
or
c) completed at least 6 visits in MG0004 [NCT04124965]
- Body weight >=35 kg at Baseline (Day 1)
- Study participants may be male or female

- Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications
- 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)
- Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003 or MG0004, or permanently discontinued study drug in either study
- Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of rozanolixizumab
- 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

Both

Generalized Myasthenia Gravis

Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.

1. Percentage of participants with treatment-emergent adverse events (TEAEs)
2. Percentage of participants with (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP)

1. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MGADL) score within one treatment cycle
2. Change from Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) score within one treatment cycle
3. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) score within one treatment cycle
4. Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) ' Muscle Weakness Fatigability' score within one treatment cycle
5. Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO ' Physical Fatigue' score within one treatment cycle
6. Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO ' Bulbar symptoms' score within one treatment cycle
7. MG-ADL responder (>=2.0-point improvement from Baseline [Day 1] to end of Day 43) within one treatment cycle
8. Time to MG-ADL response (>=2.0-point improvement from Baseline [Day 1]) within one treatment cycle
9. Time between consecutive treatment cycles

+81-198-23-3311

Dec. 14, 2020

Yes

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.

Belgium/Canada /Czech Republic, /Denmark/France/Georgia/Germany/Hungary/Italy/Poland/Russian Federation/Serbia/Spain/Taiwan/UK/US