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Clinical Trials/NL-OMON52611
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

Hansa Biopharma AB0 sites10 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
10
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

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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