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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03943589
Recruitment Status Recruiting
First Posted May 9, 2019
Last update posted April 12, 2021
The study participants are patients which have been diagnosed with Guillain-Barré Syndrome (GBS) and are planned to receive treatment with intravenous immunoglobulin (IVIg). IVIg is a standard of care treatment for GBS patients. The patients in this study will be treated with the study medicine imlifidase on day 1, and with IVIg on days 3-7. The purpose of this study is to investigate the safety and effectiveness of imlifidase in patients diagnosed with GBS.
This is an open-label, single arm, multi-centre, phase II study of imlifidase in combination with standard care IVIg in patients with GBS. The study will recruit approximately 30 patients who are eligible for IVIg treatment based on current practice (i.e. GBS disability score >3 and within 10 days of onset of weakness). All patients will receive imlifidase (Day 1) prior to standard care IVIg. Data from each patient enrolled in this study will be compared with a control group consisting of up to 4 subjects from the International Guillain-Barré Syndrome Outcome Study (IGOS) database (ClinicalTrials.gov identifier: NCT01582763) fulfilling a subset of the eligibility criteria in the current imlifidase GBS study protocol. Matching will be done on geographical locations, age, presence of diarrhoea, and severity of condition. There is growing body of evidence suggesting that GBS is an antibody-mediated disorder. In addition to supportive care, IVIg and Plasma Exchange (PE) are the two main immunological treatment options aimed at attenuating the autoreactive humoral immune response. Imlifidase is an IgG degrading enzyme with strict specificity. The hypothesis is that reduction of pathological antibodies may result in aborted progression, quicker recovery and less severe disease.
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1. IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
All subjects will receive imlifidase (Day 1) prior to standard care IVIg
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
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 child-bearing potential willing or able to use at least one highly effective
contraceptive method from the screening visit until at least 180 days following
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 immunoglobulin A (IgA) deficiency.
8. Hypersensitivity to IVIg or to any of the excipients.
9. Immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycophenolate mofetil,
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 should not have received other investigational drugs within 5 half-lives
prior to imlifidase dosing.
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.
Contact: Charlotte Elfving, BSc +46 705 15 29 15 firstname.lastname@example.org
CHU Le Kremlin-Bicêtre. Service Neurologie
CHU Bordeaux - Hôpital Pellegrin Tripode
CHU de Limoges - Hôpital Dupuytren
Hôpital de la Timone - Centre de référence des maladies neuromusculaires et de la SLA
CHU de Montpellier, Hôpital Gui de Chauliac
Centre Hospitalier Universitaire de Nantes
Erasmus Medical Centre
Queen Elizabeth University Hospital Glasgow
Hansa Biopharma AB
Study Chair: Elisabeth Sonesson, PhD Hansa Biopharma AB