Back to resultsA Study of Imlifidase in Patients With Guillain-Barré Syndrome
Primary Purpose
Guillain-Barré Syndrome (GBS)
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Imlifidase
Sponsored by
About this trial
This is an interventional treatment trial for Guillain-Barré Syndrome (GBS)
Eligibility Criteria
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- 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
- Service de neurologie, Hôpitaux Universitaires de Strasbourg
- Amsterdam UMC
- Erasmus Medical Centre
- Queen Elizabeth University Hospital Glasgow
- Oxford University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imlifidase
Arm Description
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.
Outcomes
Primary Outcome Measures
Safety as measured by Adverse Events (AEs)
Safety is assessed as type, frequency and intensity of Adverse Events (AE)/Serious Adverse Events (SAEs)
Changed disability outcome at 4 weeks assessed by the 6-point GBS disability score (DS)
Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS at 4 weeks.
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
Secondary Outcome Measures
Mean change in disability outcome at week 4 as assessed by the 6-point GBS DS
Efficacy is assessed as mean change from screening in GBS DS grade (on the 6-points GBS DS) at 4 weeks.
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
Ability to walk unaided at 4, 8 and 26 weeks
Efficacy is assessed as proportion of subjects able to walk unaided (i.e. GBS DS=2) at 4, 8 and 26 weeks
Time to improvement by at least one (1) GBS DS grade
Efficacy is assessed as time to improvement by at least one (1) GBS DS grade.
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
Time to walk unaided
Efficacy is assessed as time to walk unaided (i.e. GBS DS=2)
Change from baseline in R-ODS by at least 6 Points at 4, 8, and 26 weeks
Efficacy is assessed as proportion of subjects with an increase from baseline in Rasch-built Overall Disability scale (R-ODS) by at least 6 Points on the centile metric score at 4, 8 and 26 weeks
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).
Requirement for ventilator support
Efficacy is assessed as proportion of subjects requiring ventilator support (i.e. GBS DS=5)
Time in ventilator
Efficacy is assessed as time in ventilator (counted only if at least 12 hours/day)
Time in an ICU
Efficacy is assessed as time in an intensive care unit (ICU)
Changes in MRC sum score
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
PK profile of imlifidase: Cmax
Cmax=Maximum observed plasma concentration of imlifidase following dosing
PK profile of imlifidase: Tmax
Tmax=Time point for maximum observed plasma concentration of imlifidase following dosing
PK profile of imlifidase: AUC
AUC=Area under the imlifidase plasma concentration versus time curve
PK profile of imlifidase: t1/2
t1/2=Terminal half-life of imlifidase
PK profile of imlifidase: CL
CL=Clearance of imlifidase
PK profile of imlifidase: V
V=Volume of distribution
PD effect on IgG
The PD effect on IgG will be described qualitatively on a scale. The scale range from score=0 (no intact IgG, single cleaved IgG (scIgG) or F(ab')2 to score=5 (only intact IgG)
Presence of ADAs
Proportion of patients with anti-imlifidase antibodies (ADAs) at different time-points during the study
Patient's health state as assessed by EQ-5D Quality of Life questionnaire
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 descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient indicates health state in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03943589
Brief Title
A Study of Imlifidase in Patients With Guillain-Barré Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hansa Biopharma AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain-Barré Syndrome (GBS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Data from each patient enrolled in this study will be compared with a control group consisting of up to 4 subjects treated with IVIg only 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imlifidase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Imlifidase
Other Intervention Name(s)
Hansa Medical-Immunoglobulin G degrading enzyme of Streptococcus pyogenes (HMED-IdeS), IdeS, IgG endopeptidase
Intervention Description
All subjects will receive imlifidase (Day 1) prior to standard care IVIg
Primary Outcome Measure Information:
Title
Safety as measured by Adverse Events (AEs)
Description
Safety is assessed as type, frequency and intensity of Adverse Events (AE)/Serious Adverse Events (SAEs)
Time Frame
Screening up to Day 360
Title
Changed disability outcome at 4 weeks assessed by the 6-point GBS disability score (DS)
Description
Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS at 4 weeks.
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
Time Frame
Screening and Day 29
Secondary Outcome Measure Information:
Title
Mean change in disability outcome at week 4 as assessed by the 6-point GBS DS
Description
Efficacy is assessed as mean change from screening in GBS DS grade (on the 6-points GBS DS) at 4 weeks.
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
Time Frame
Screening and Day 29
Title
Ability to walk unaided at 4, 8 and 26 weeks
Description
Efficacy is assessed as proportion of subjects able to walk unaided (i.e. GBS DS=2) at 4, 8 and 26 weeks
Time Frame
Day 29, Day 57, and Day 180
Title
Time to improvement by at least one (1) GBS DS grade
Description
Efficacy is assessed as time to improvement by at least one (1) GBS DS grade.
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
Time Frame
Screening until Day 360
Title
Time to walk unaided
Description
Efficacy is assessed as time to walk unaided (i.e. GBS DS=2)
Time Frame
Screening until Day 360
Title
Change from baseline in R-ODS by at least 6 Points at 4, 8, and 26 weeks
Description
Efficacy is assessed as proportion of subjects with an increase from baseline in Rasch-built Overall Disability scale (R-ODS) by at least 6 Points on the centile metric score at 4, 8 and 26 weeks
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).
Time Frame
Screening, Day 29, Day 57, and Day 180
Title
Requirement for ventilator support
Description
Efficacy is assessed as proportion of subjects requiring ventilator support (i.e. GBS DS=5)
Time Frame
Screening until Day 360
Title
Time in ventilator
Description
Efficacy is assessed as time in ventilator (counted only if at least 12 hours/day)
Time Frame
Screening until Day 360
Title
Time in an ICU
Description
Efficacy is assessed as time in an intensive care unit (ICU)
Time Frame
Screening until Day 360
Title
Changes in MRC sum score
Description
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
Time Frame
Screening until Day 180
Title
PK profile of imlifidase: Cmax
Description
Cmax=Maximum observed plasma concentration of imlifidase following dosing
Time Frame
Within 2 hours before imlifidase dose until Day 15
Title
PK profile of imlifidase: Tmax
Description
Tmax=Time point for maximum observed plasma concentration of imlifidase following dosing
Time Frame
Within 2 hours before imlifidase dose until Day 15
Title
PK profile of imlifidase: AUC
Description
AUC=Area under the imlifidase plasma concentration versus time curve
Time Frame
Within 2 hours before imlifidase dose until Day 15
Title
PK profile of imlifidase: t1/2
Description
t1/2=Terminal half-life of imlifidase
Time Frame
Within 2 hours before imlifidase dose until Day 15
Title
PK profile of imlifidase: CL
Description
CL=Clearance of imlifidase
Time Frame
Within 2 hours before imlifidase dose until Day 15
Title
PK profile of imlifidase: V
Description
V=Volume of distribution
Time Frame
Within 2 hours before imlifidase dose until Day 15
Title
PD effect on IgG
Description
The PD effect on IgG will be described qualitatively on a scale. The scale range from score=0 (no intact IgG, single cleaved IgG (scIgG) or F(ab')2 to score=5 (only intact IgG)
Time Frame
Within 2 hours before imlifidase dose until Day 15
Title
Presence of ADAs
Description
Proportion of patients with anti-imlifidase antibodies (ADAs) at different time-points during the study
Time Frame
Within 2 hours before imlifidase dose until Day 180
Title
Patient's health state as assessed by EQ-5D Quality of Life questionnaire
Description
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 descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient indicates health state in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time Frame
Day 8, Day 15, Day 29, Day 57, Day 92, Day 180, and Day 360
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Operations
Organizational Affiliation
Hansa Biopharma AB
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Le Kremlin-Bicêtre. Service Neurologie
City
Le Kremlin-Bicêtre
State/Province
Paris
ZIP/Postal Code
94270
Country
France
Facility Name
CHU Bordeaux - Hôpital Pellegrin Tripode
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de Limoges - Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Hôpital de la Timone - Centre de référence des maladies neuromusculaires et de la SLA
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU de Montpellier, Hôpital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Service de neurologie, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67 098
Country
France
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Facility Name
Erasmus Medical Centre
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Queen Elizabeth University Hospital Glasgow
City
Glasgow
Country
United Kingdom
Facility Name
Oxford University Hospital
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Imlifidase in Patients With Guillain-Barré Syndrome
We'll reach out to this number within 24 hrs