A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis

Phase 1

• Conditions: Generalized myasthenia gravis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2019-000968-18-CZ
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-13
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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
- Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1
- Study participant with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 3 (with =3 points from non-ocular symptom) AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline (Visit 2)
- Study participant is considered for additional treatment such as intravenous immunoglobulin g (IVIg) or plasma exchange (PEX) by the Investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

- Study participant has a known history of hyperprolinemia
- Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
-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) will be excluded
- Study participant has experienced hypersensitivity reaction after exposure to other antineonatal Fc receptor (FcRn) drugs
- 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 at Visit 1 or Visit 2
- Study participant has a history of a solid organ transplant or hematopoietic stem cell/marrow transplant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified