Guillain-Barré Syndrome (GBS)Phase 2NCT03943589
A Study of Imlifidase in Patients With Guillain-Barré Syndrome
A Phase 2 study testing Imlifidase in people with Guillain-Barré Syndrome (GBS), run by Hansa Biopharma AB at 11 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain-Barré Syndrome (GBS)
- What is being tested?
- Imlifidase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 12 Nov 2019to 27 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent obtained before any study-related procedures.
- Willingness and ability to comply with the protocol.
- Male or female aged ≥18 years at the time of screening.
- GBS diagnosed according to National Institute of Neurological Disorders and Stroke (NINDS) diagnostic criteria (Asbury et al. 1990).
- Onset of weakness due to GBS is not more than 10 days prior to screening.
- Unable to walk unaided for >10 meters (grade ≥ 3 on GBS DS).
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- IVIg treatment being considered.
- 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.
- 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.
Who cannot join
- Previous treatment with imlifidase.
- Previous IVIg treatment within 28 days prior to imlifidase treatment.
- Subjects who are being considered for, or already on, PE.
- 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 imlifidase dosing.
- Breastfeeding or pregnancy
- Clinical evidence of a polyneuropathy of another cause e.g. diabetes mellitus (except mild sensory), alcoholism, vitamin deficiency, or porphyria.
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- Known selective immunoglobulin A (IgA) deficiency.
- Hypersensitivity to IVIg or to any of the excipients.
- Immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, sirolimus or > 20 mg prednisolone daily) during the last month.
- Subject known to have a severe concurrent disease, e.g. malignancy, severe cardiovascular disease and severe chronic obstructive pulmonary disease (COPD).
- 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.
- Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the study activities.
- Subjects with clinical signs of ongoing infection.
- Subjects should not have received other investigational drugs within 5 half-lives prior to imlifidase dosing.
- Present or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP.
- Positive PCR test for SARS-CoV-2 virus infection.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
France7 sites
CHU Bordeaux - Hôpital Pellegrin Tripode
Bordeaux, 33076
CHU Le Kremlin-Bicêtre. Service Neurologie
Le Kremlin-Bicêtre, Paris, 94270
CHU de Limoges - Hôpital Dupuytren
Limoges, 87000
Hôpital de la Timone - Centre de référence des maladies neuromusculaires et de la SLA
Marseille, 13385
CHU de Montpellier, Hôpital Gui de Chauliac
Montpellier, 34295
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Service de neurologie, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67 098
Netherlands2 sites
Amsterdam UMC
Amsterdam
Erasmus Medical Centre
Rotterdam, 3015 GD
United Kingdom2 sites
Queen Elizabeth University Hospital Glasgow
Glasgow
Oxford University Hospital
Oxford
About this study
Official title: An Open-label, Single Arm, Multi-centre, Phase II Study Investigating Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of Imlifidase in Patients With Guillain-Barré Syndrome, in Comparison With Matched Control Patients
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.
Read the detailed description
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.
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.
- Conditions
- Guillain-Barré Syndrome (GBS)
- Being tested
- Imlifidase
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImlifidaseDrug
Also called Hansa Medical-Immunoglobulin G degrading enzyme of Streptococcus pyogenes (HMED-IdeS), IdeS, IgG endopeptidase
All subjects will receive imlifidase (Day 1) prior to standard care IVIg
| Study group | Role | What they receive |
|---|---|---|
| Imlifidase | Experimental | 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. Receives: Drug: Imlifidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 1 Grade
Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS over time.
The 6-point Guillain Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Measured: Baseline to Day 360
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 2 Grades
Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS over time.
The 6-point Guillain Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Measured: Baseline to Day 360
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Efficacy is assessed as proportion of subjects able to walk unaided (i.e. GBS DS=2) over time
Measured: Baseline to Day 360
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Efficacy is assessed as proportion of patients able to run (i.e. Guillain Barré Syndrome disability score [GBS DS] ≤1) over time
Measured: Baseline to Day 360
Mean MRC Sum Score Over Time
Efficacy is assessed as Medical Research Council (MRC) sum score over time.
The MRC sum score is widely used to assess the motor impairment in subjects with peripheral neuropathies. It is a sum score of power in 6 muscle groups on each side (abduction of arm, flexion of forearm, extension of the wrist, hip flexion, and extension of knee and dorsal flexion of the foot). The sum of these scores ranges from 0 (total paralysis) to 60 (normal power). It provides valuable information about the muscle strength. Change in MRC sum score helps in identification of GBS patients with treatment related fluctuation or exacerbation. The individual MRC grades are defined as follows: 0=No visible contraction,1=Visible contraction without movement of the limb, 2=Movement of the limb but not against gravity, 3=Movement against gravity (almost full range), 4=Movement against gravity and resistance, 5=Normal
Measured: Baseline until Day 180
Change From Baseline in MRC Sum Score Over Time
Efficacy is assessed as change in Medical Research Council (MRC) sum score.
The MRC sum score is widely used to assess the motor impairment in subjects with peripheral neuropathies. It is a sum score of power in 6 muscle groups on each side (abduction of arm, flexion of forearm, extension of the wrist, hip flexion, and extension of knee and dorsal flexion of the foot). The sum of these scores ranges from 0 (total paralysis) to 60 (normal power). It provides valuable information about the muscle strength. Change in MRC sum score helps in identification of GBS patients with treatment related fluctuation or exacerbation. The individual MRC grades are defined as follows: 0=No visible contraction,1=Visible contraction without movement of the limb, 2=Movement of the limb but not against gravity, 3=Movement against gravity (almost full range), 4=Movement against gravity and resistance, 5=Normal
Measured: Baseline until Day 180
Mean R-ODS Over Time
The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire.
R-ODS is a linearly weighted disease specific scale, which captures activities and social participation limitation in patients with immune-mediated neuropathies, including GBS. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The response options for each item are: 0=Not possible, 1=Possible with effort, 2=Easy to perform. The obtained raw summed score is subsequently translated to a centile metric ranging from 0 (most severe disability) to 100 (no disability at all).
Measured: Baseline to Day 360
Change From Baseline in R-ODS Over Time
The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire.
R-ODS is a linearly weighted disease specific scale, which captures activities and social participation limitation in patients with immune-mediated neuropathies, including GBS. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The response options for each item are: 0=Not possible, 1=Possible with effort, 2=Easy to perform. The obtained raw summed score is subsequently translated to a centile metric ranging from 0 (most severe disability) to 100 (no disability at all).
Measured: Baseline to Day 360
Days in Hospital
The number of days the patients were admitted to hospital
Measured: Baseline to Day 360
Time in an ICU
Efficacy is assessed as time in an intensive care unit (ICU)
Measured: Baseline until Day 360
Need for Mechanical Ventilation
Measured: Baseline until Day 180
Patient's Health State Over Time as Assessed by EQ VAS
Quality of Life will be assessed using the EurQol group's EurQol - 5 dimension (EQ-5D) Health questionnaire.
The EQ-5D consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS records the patient's self-rated health on a vertical scale, where score 100 is 'The best health you can imagine' and score 0 is the 'The worst health you can imagine'.
Measured: Day 8, Day 15, Day 29, Day 57, Day 92, Day 180, and Day 360
Secondary outcomes (8)
PK Profile of Imlifidase: Cmax
Cmax=Maximum observed plasma concentration of imlifidase following dosing
Measured: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: Tmax
Tmax=Time point for maximum observed plasma concentration of imlifidase following dosing
Measured: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: AUC
AUC=Area under the imlifidase plasma concentration versus time curve
Measured: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: t1/2
t1/2=Terminal half-life of imlifidase
Measured: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: CL
CL=Clearance of imlifidase
Measured: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: V
V=Volume of distribution
Measured: Within 2 hours before imlifidase dose until Day 15
Pharmacodynamics - IgG Level in Serum Over Time
The pharmacodynamic (PD) effect of imlifidase is assessed as the elimination of IgG. IgG is cleaved by imlifidase in two steps, the first cut generates single-cleaved IgG (scIgG), and the second cut generates one F(ab')2 fragment and one Fc fragment. The IgG concentration measured in serum using the MSD technology is the sum of intact IgG and scIgG and a decrease in the measured IgG concentration therefore represents complete cleavage of the IgG molecule to Fc and F(ab')2 fragments. For the first 16 patients included in the trial a more frequent PD sampling schedule was conducted. After amending the protocol a less frequent PD sampling schedule was applied.
Measured: Within 2 hours before imlifidase dose until Day 15
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Anti-imlifidase IgG antibodies (ADA) in serum.
Measured: Within 2 hours before imlifidase dose until Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start12 Nov 2019
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Guillain-Barré Syndrome (GBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Data from patients enrolled in this trial will, if feasible, be compared with an external control group consisting of patients from the IGOS database (International Guillain-Barré Syndrome Outcome Study, ClinicalTrials.gov Identifier: NCT01582763).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hansa Biopharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Operations, Study chair, Hansa Biopharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943589
- Sponsor's protocol ID
- 15-HMedIdeS-09
- Status last verified
- Mar 2025
- First submitted
- 30 Apr 2019
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Arm, Multi-centre, Phase II Study Investigating Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of Imlifidase in Patients With Guillain-Barré Syndrome, in Comparison With Matched Control Patients
- ClinicalTrials.gov ID
- NCT03943589
- Acronym / sponsor ID
- 15-HMedIdeS-09
- Conditions
- Guillain-Barré Syndrome (GBS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hansa Biopharma ABIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Data from patients enrolled in this trial will, if feasible, be compared with an external control group consisting of patients from the IGOS database (International Guillain-Barré Syndrome Outcome Study, ClinicalTrials.gov Identifier: NCT01582763).
| Arm | Type | Receives |
|---|---|---|
| Imlifidase | Experimental | Drug: ImlifidaseOne (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed Informed Consent obtained before any study-related procedures.
- Willingness and ability to comply with the protocol.
- Male or female aged ≥18 years at the time of screening.
- GBS diagnosed according to National Institute of Neurological Disorders and Stroke (NINDS) diagnostic criteria (Asbury et al. 1990).
- Onset of weakness due to GBS is not more than 10 days prior to screening.
Key exclusion criteria (16 listed)
- Previous treatment with imlifidase.
- Previous IVIg treatment within 28 days prior to imlifidase treatment.
- Subjects who are being considered for, or already on, PE.
- 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 imlifidase dosing.
- Breastfeeding or pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImlifidaseAlso: Hansa Medical-Immunoglobulin G degrading enzyme of Streptococcus pyogenes (HMED-IdeS), IdeS, IgG endopeptidaseAll subjects will receive imlifidase (Day 1) prior to standard care IVIg | Drug | Imlifidase |
Primary outcome
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 1 Grade
Time frame: Baseline to Day 360
Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS over time. The 6-point Guillain Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 2 Grades
Time frame: Baseline to Day 360
Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS over time. The 6-point Guillain Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Time frame: Baseline to Day 360
Efficacy is assessed as proportion of subjects able to walk unaided (i.e. GBS DS=2) over time
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Time frame: Baseline to Day 360
Efficacy is assessed as proportion of patients able to run (i.e. Guillain Barré Syndrome disability score [GBS DS] ≤1) over time
Mean MRC Sum Score Over Time
Time frame: Baseline until Day 180
Efficacy is assessed as Medical Research Council (MRC) sum score over time. The MRC sum score is widely used to assess the motor impairment in subjects with peripheral neuropathies. It is a sum score of power in 6 muscle groups on each side (abduction of arm, flexion of forearm, extension of the wrist, hip flexion, and extension of knee and dorsal flexion of the foot). The sum of these scores ranges from 0 (total paralysis) to 60 (normal power). It provides valuable information about the muscle strength. Change in MRC sum score helps in identification of GBS patients with treatment related fluctuation or exacerbation. The individual MRC grades are defined as follows: 0=No visible contraction,1=Visible contraction without movement of the limb, 2=Movement of the limb but not against gravity, 3=Movement against gravity (almost full range), 4=Movement against gravity and resistance, 5=Normal
Change From Baseline in MRC Sum Score Over Time
Time frame: Baseline until Day 180
Efficacy is assessed as change in Medical Research Council (MRC) sum score. The MRC sum score is widely used to assess the motor impairment in subjects with peripheral neuropathies. It is a sum score of power in 6 muscle groups on each side (abduction of arm, flexion of forearm, extension of the wrist, hip flexion, and extension of knee and dorsal flexion of the foot). The sum of these scores ranges from 0 (total paralysis) to 60 (normal power). It provides valuable information about the muscle strength. Change in MRC sum score helps in identification of GBS patients with treatment related fluctuation or exacerbation. The individual MRC grades are defined as follows: 0=No visible contraction,1=Visible contraction without movement of the limb, 2=Movement of the limb but not against gravity, 3=Movement against gravity (almost full range), 4=Movement against gravity and resistance, 5=Normal
Mean R-ODS Over Time
Time frame: Baseline to Day 360
The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire. R-ODS is a linearly weighted disease specific scale, which captures activities and social participation limitation in patients with immune-mediated neuropathies, including GBS. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The response options for each item are: 0=Not possible, 1=Possible with effort, 2=Easy to perform. The obtained raw summed score is subsequently translated to a centile metric ranging from 0 (most severe disability) to 100 (no disability at all).
Change From Baseline in R-ODS Over Time
Time frame: Baseline to Day 360
The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire. R-ODS is a linearly weighted disease specific scale, which captures activities and social participation limitation in patients with immune-mediated neuropathies, including GBS. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The response options for each item are: 0=Not possible, 1=Possible with effort, 2=Easy to perform. The obtained raw summed score is subsequently translated to a centile metric ranging from 0 (most severe disability) to 100 (no disability at all).
Days in Hospital
Time frame: Baseline to Day 360
The number of days the patients were admitted to hospital
Time in an ICU
Time frame: Baseline until Day 360
Efficacy is assessed as time in an intensive care unit (ICU)
Need for Mechanical Ventilation
Time frame: Baseline until Day 180
Patient's Health State Over Time as Assessed by EQ VAS
Time frame: Day 8, Day 15, Day 29, Day 57, Day 92, Day 180, and Day 360
Quality of Life will be assessed using the EurQol group's EurQol - 5 dimension (EQ-5D) Health questionnaire. The EQ-5D consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS records the patient's self-rated health on a vertical scale, where score 100 is 'The best health you can imagine' and score 0 is the 'The worst health you can imagine'.
8 secondary outcomes
PK Profile of Imlifidase: Cmax
Time frame: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: Tmax
Time frame: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: AUC
Time frame: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: t1/2
Time frame: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: CL
Time frame: Within 2 hours before imlifidase dose until Day 15
PK Profile of Imlifidase: V
Time frame: Within 2 hours before imlifidase dose until Day 15
Pharmacodynamics - IgG Level in Serum Over Time
Time frame: Within 2 hours before imlifidase dose until Day 15
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Time frame: Within 2 hours before imlifidase dose until Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Operations study chair
Hansa Biopharma AB
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imlifidase in people with Guillain-Barré Syndrome (GBS), run by Hansa Biopharma AB at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 1 Grade (time frame: Baseline to Day 360). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.