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
- Conditions
- Guillain Barré Syndrome1002766510029305
- Registration Number
- NL-OMON52611
- Lead Sponsor
- Hansa Biopharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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.
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Endpoints<br /><br><br /><br>• Safety as measured by type, frequency and intensity of Adverse Event (AE) /<br /><br>Serious Adverse Event (SAE) and change from baseline in parameters of clinical<br /><br>laboratory tests, vital signs and Electrocardiograms (ECG)</p><br>
- Secondary Outcome Measures
Name Time Method