Trial · NCT03943589

A Study of Imlifidase in Patients With Guillain-Barré Syndrome

NCT03943589, Phase 2, Completed, Hansa Biopharma AB; results first posted 2025-04-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Imlifidase in Patients With Guillain-Barré Syndrome. Trials, record NCT03943589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03943589

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Imlifidase in Patients With Guillain-Barré Syndrome
NCT number: NCT03943589
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Hansa Biopharma AB
Conditions: Guillain-Barré Syndrome (GBS)
Interventions: Imlifidase
First posted: 2019-05-09
Last updated: 2025-04-09
Results first posted: 2025-04-09

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 1 Grade	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
Primary	Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 2 Grades	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
Primary	Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Baseline to Day 360	Efficacy is assessed as proportion of subjects able to walk unaided (i.e. GBS DS=2) over time
Primary	Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)	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
Primary	Mean MRC Sum Score Over Time	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
Primary	Change From Baseline in MRC Sum Score Over Time	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
Primary	Mean R-ODS Over Time	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).
Primary	Change From Baseline in R-ODS Over Time	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).
Primary	Days in Hospital	Baseline to Day 360	The number of days the patients were admitted to hospital
Primary	Time in an ICU	Baseline until Day 360	Efficacy is assessed as time in an intensive care unit (ICU)

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 1 Grade	Baseline to Day 360	The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.	days	MEDIAN
PRIMARY	Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 2 Grades	Baseline to Day 360	The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.	days	MEDIAN
PRIMARY	Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Baseline to Day 360	The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)	Baseline to Day 360	The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Mean MRC Sum Score Over Time	Baseline until Day 180	The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.~26 patients with data at Day 6 and Day 8, 25 patients with data at Day 15	score on a scale	MEAN
PRIMARY	Change From Baseline in MRC Sum Score Over Time	Baseline until Day 180	The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.~26 patients with data at Day 6 and Day 8, 25 patients with data at Day 15	score on a scale	MEAN
PRIMARY	Mean R-ODS Over Time	Baseline to Day 360	The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.~24 patients with data at Day 15, 26 patients with data at Day 8, Day 57, Day 92 and day 360.	score on a scale	MEAN
PRIMARY	Change From Baseline in R-ODS Over Time	Baseline to Day 360	The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.~24 patients with data at Day 15, 26 patients with data at Day 8, Day 57, Day 92 and day 360.	score on a scale	MEAN
PRIMARY	Days in Hospital	Baseline to Day 360	Safety analysis set	days	MEAN
PRIMARY	Time in an ICU	Baseline until Day 360	Safety analysis set	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group106

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 1 Grade	Imlifidase		6.0	Full Range 3.0 to 16.0	days
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 2 Grades	Imlifidase		16.0	Full Range 8.0 to 92.0	days
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Imlifidase	Baseline	0		Participants
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Imlifidase	Day 2	4		Participants
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Imlifidase	Day 3	5		Participants
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Imlifidase	Day 4	9		Participants
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Imlifidase	Day 5	9		Participants
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Imlifidase	Day 6	9		Participants
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Imlifidase	Day 7	10		Participants
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided	Imlifidase	Day 8	10		Participants

1 to 10 of 106Source ClinicalTrials.gov

See all 106 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Imlifidase	30
Overall Study	COMPLETED	Imlifidase	28
Overall Study	NOT COMPLETED	Imlifidase	2

Source ClinicalTrials.gov

Adverse events145

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Imlifidase	9	30	9
other	Abdominal pain	Gastrointestinal disorders	Imlifidase	1	30	1
other	Abdominal pain upper	Gastrointestinal disorders	Imlifidase	1	30	1
other	Cheilitis	Gastrointestinal disorders	Imlifidase	1	30	1
other	Diarrhoea	Gastrointestinal disorders	Imlifidase	1	30	1
other	Faecaloma	Gastrointestinal disorders	Imlifidase	1	30	1
other	Gastritis	Gastrointestinal disorders	Imlifidase	1	30	1
other	Gastrointestinal motility disorder	Gastrointestinal disorders	Imlifidase	1	30	1
other	Inguinal hernia	Gastrointestinal disorders	Imlifidase	1	30	1
other	Intestinal pseudo-obstruction	Gastrointestinal disorders	Imlifidase	1	30	1

1 to 10 of 145Source ClinicalTrials.gov

See all 145 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Imlifidase	1	30
Total, other adverse events	Imlifidase	28	30
Total, serious adverse events	Imlifidase	7	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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