Guillain-Barré Syndrome (GBS) MedDRA version: 21.1 Level: LLT Classification code 10018766 Term: Guillain Barre syndrome System Organ Class: 100000004852
Conditions
Interventions
Product Name: Imlifidase
Product Code: Imlifidase
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Imlifidase
CAS Number: 1947415-68-0
Other descriptive name:
Sponsors
Hansa Biopharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent obtained before any study-related procedures. 2. Willingness and ability to comply with the protocol. 3. Male or female aged =18 years at the time of screening. 4. GBS diagnosed according to National Institute of Neurological Disorders and Stroke (NINDS) diagnostic criteria (Asbury et al. 1990) 5. Onset of weakness due to GBS is not more than 10 days prior to screening. 6. Unable to walk unaided for >10 meters (grade = 3 on GBS DS). 7. IVIg treatment being considered. 8. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method from the day of treatment until at least 6 months after the dose of imlifidase if not abstinent. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. 9. Men willing to use double-barrier contraception from the day of treatment until at least 2 months after the dose of imlifidase if not abstinent. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Previous treatment with imlifidase. 2. Previous IVIg treatment within 28 days prior to imlifidase treatment. 3. Subjects who are being considered for, or already on, PE. 4. Women of childbearing potential who are not willing to use contraception from the screening visit until at least 180 days following imlifidase dosing. 5. Breastfeeding or pregnancy 6. Clinical evidence of a polyneuropathy of another cause e.g. diabetes mellitus (except mild sensory), alcoholism, vitamin deficiency, or porphyria. 7. Known selective IgA deficiency. 8. Hypersensitivity to IVIg or to any of the excipients. 9. Immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil, tacrolimus, sirolimus or > 20 mg prednisolone daily) during the last month. 10. Subject known to have a severe concurrent disease, e.g. malignancy, severe cardiovascular disease and severe chronic obstructive pulmonary disease (COPD). 11. Any condition that in the opinion of the investigator could increase the subject's risk by participating in the study or confound the outcome of the study. 12. Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the study activities. 13. Subjects with clinical signs of ongoing infectious diseases that requires treatment. 14. Subjects who have received other investigational drugs within 5 halflives prior to imlifidase dosing. A subject will be withdrawn from the study if more than 12 days elapse between the onset of weakness and planned imlifidase administration, thus preventing that the administration of IVIg after imlifidase administration would be later than 14 days after onset of weakness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess safety and tolerability of imlifidase in combination with standard IVIg treatment in GBS subjects;Secondary Objective: • Evaluate pharmacokinetics of imlifidase • Evaluate pharmacodynamics profile of imlifidase • Evaluate efficacy of imlifidase in subjects with GBS • Compare the outcome of GBS subjects after a dose of imlifidase in combination with standard IVIg treatment with matched control subjects obtained as part of the IGOS study with respect to reduction in severity of symptoms and improved recovery time in terms of: • Evaluate time to improvement on the GBS DS • Evaluate time to walk independently (DS 2) • Evaluate proportion of subjects with a clinically relevant improvement in R-ODS score • Evaluate proportion of subjects requiring ventilator support (GBS DS 5) • Evaluate time on a ventilator;Primary end point(s): Safety as measured by type, frequency and intensity of Adverse Event (AE) / Serious Adverse Event (SAE) and change from baseline in parameters of clinical laboratory tests, vital signs and Electrocardiograms (ECG).;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Efficacy as assessed by the proportion of subjects with improvement of one or more grades in disability outcome (on the 6-point GBS DS) • Time to walk independently (DS 2). • Proportion of subjects with an increase from baseline in R-ODS score by at least 6 points on the centile metric score at 4, 8 and 26 weeks. • Proportion of subjects requiring ventilator support (GBS disability score 5). • Time on a ventilator (counted only if at least 12 hours/day). • Pharmacokinetics (PK) parameters Cmax, Area under the curve (AUC), tmax, t½, V, Clearance (CL), of imlifidase • Pharmacodynamics (PD) effect by means of time course of IgG following administration of imlifidase ;Timepoint(s) of evaluation of this end point: Efficacy: at 4 weeks | — |
Countries
France, Netherlands, United Kingdom
Contacts
Public ContactClinical Study Information
Hansa Biopharma AB
Outcome results
None listed