Moderate to severe myasthenia gravis MedDRA version: 20.0 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: UCB7665
Product Code: UCB7665
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: rozanolixizumab
CAS Number: 1584645-37-3
Current Sponsor code: UCB7665
Other desc
Sponsors
UCB Biopharma SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has a well-documented diagnosis of myasthenia gravis (MG) at Visit 1 (Screening), based on subject history and supported by previous evaluations - Subject would currently be considered for treatment with immunological therapy (immunoglobulin/plasma exchange (IVIG/PLEX)) by the investigator - Subject has well-documented record of autoantibodies against antiacetylcholine receptor (Anti-AChR) or anti-muscle specific kinase (AntiMuSK) prior to Screening - Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential applicable willing to use a highly effective method of birth control - Male subjects must be willing to use a method of contraception 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 37 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Subject has previously received treatment in this study or subject has previously been exposed to UCB7665 - Subject has participated in another study of an investigational medicinal product (IMP;or a medical device) within the previous 30 days of Screening or is currently participating in another study of an investigational medicinal product (IMP; or a medical device) - Subject has a known hypersensitivity to any components of the IMP - Subject has a history of hyperprolinemia, since L-proline is a constituent of the UCB7665 IMP - Subjects with Myasthenia Gravis (MG) only affecting the ocular muscles - Subjects with severe weakness affecting oropharyngeal or respiratory muscles, or who have myasthenic crisis at Screening or impending crisis - Subject has quantitative myasthenia gravis (QMG) score of <11 at Baseline - Subject has a serum total immunoglobulin G (IgG) level <= 6g/L at Screening - Absolute neutrophil count <1500 cells/mm3 - Subject has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study - Subject has any laboratory abnormality that, in the opinion of the investigator, is clinically significant, has not resolved at randomization, and could jeopardize or would compromise the subject’s ability to participate in this study - Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP - Subject has received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the clinical efficacy of UCB7665 as a chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate to severe ;Secondary Objective: - Gather data for future study planning, whether for chronic-intermittent treatment or a longer therapy option by evaluating the general concept that UCB7665 has a clinical effect in patients with generalized myasthenia gravis (MG) - Evaluate the safety and tolerability of UCB7665 administered by subcutaneous (sc) infusion in subjects with (MG) - Assess the effect of UCB7665 as measured by total immunoglobulin G (IgG) concentrations in serum ;Primary end point(s): Change from Baseline in Quantitative Myasthenia Gravis (QMG) score to Visit 9 ;Timepoint(s) of evaluation of this end point: Baseline and Visit 9 (Day 29) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Baseline in Myasthenia Gravis-Composite score to Visit 9 Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) score to Visit 9 ;Timepoint(s) of evaluation of this end point: Baseline and Visit 9 (Day 29) | — |
Countries
Belgium, Canada, Czech Republic, Denmark, Germany, Spain, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed