NL-OMON52611CompletedPhase 2
An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients - Clinical study of imlifidase in patients with Guillain-Barré Syndrome
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hansa Biopharma AB
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
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
- •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 infection.
- •14. Subjects who have received other investigational drugs within 5 half-lives
- •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.
- •15. Present or history of thrombotic thrombocytopenic purpura (TTP), or known
- •familial history of TTP.
- •16. Positive PCR test for SARS-CoV-2 virus infection.
Investigators
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