ICA-GBS

Inhibition of complement activation (eculizumab®) in Guillain-Barré Syndrome study - ICA-GBS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000228-33-GB

Enrollment

Unknown

Registered

2013-10-01

Start date

2013-11-07

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Guillain-Barré Syndrome MedDRA version: 14.1 Level: LLT Classification code 10018766 Term: Guillain Barre syndrome System Organ Class: 100000004852

Interventions

Trade Name: Soliris Product Name: Eculizumab Product Code: N/A Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Eculizumab CAS Number: 219685-50-4 Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients aged =18 years diagnosed with GBS according to NINDS diagnostic criteria • Onset of weakness due to GBS is less than 2 weeks ago • Patients who are unable to walk unaided for >10 meters (grade = 3 on GBS disability scale) • Patients who are being considered for or already on IVIg treatment • First dose of eculizumab must be started within 2 weeks from onset of weakness and any time during the IVIg treatment period • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: • Age 20 mg prednisolone daily) during the last month • Patient known to have a severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS, severe COPD, TB • Inability to comply with study related procedures or appointments during 6 months • Any condition that in the opinion of the investigator could increase the patient’s risk by participating in the study or confound the outcome of the study • Related to the administration of eculizumab: ? Unresolved Neisseria meningitidis infection or history of meningococcal infection ? Unsuitable for antibiotic prophylaxis (e.g. due to allergy) ? Known hypersensitivity to eculizumab, murine proteins or to any of the excipients ? Known or suspected hereditary complement deficiencies ? Women of child-bearing potential who are unwilling to use effective contraception during treatment and for 5 months after treatment is completed.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate safety and tolerability, of eculizumab in patients with GBS.;Secondary Objective: To determine whether more GBS patients improve in functional outcome (GBS disability scale) after treatment with eculizumab and IVIg compared to placebo controls, 4 weeks after randomisation.;Primary end point(s): Primary safety endpoint To determine the incidence of AE/SAEs after treatment with eculizumab and IVIg compared to placebo controls Primary Efficacy Endpoint Improvement of one or more grade in functional outcome (on the 6 point GBS disability scale) at 4 weeks. ;Timepoint(s) of evaluation of this end point: Primary Safety endpoint timepoint will be at close of study. Primary Efficacy Endpoint will be evaluated by the research team at 4 weeks.	—

Measure

Time frame

Main Objective: To evaluate safety and tolerability, of eculizumab in patients with GBS.;Secondary Objective: To determine whether more GBS patients improve in functional outcome (GBS disability scale) after treatment with eculizumab and IVIg compared to placebo controls, 4 weeks after randomisation.;Primary end point(s): Primary safety endpoint To determine the incidence of AE/SAEs after treatment with eculizumab and IVIg compared to placebo controls Primary Efficacy Endpoint Improvement of one or more grade in functional outcome (on the 6 point GBS disability scale) at 4 weeks. ;Timepoint(s) of evaluation of this end point: Primary Safety endpoint timepoint will be at close of study. Primary Efficacy Endpoint will be evaluated by the research team at 4 weeks.

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Secondary

Measure	Time frame
Secondary end point(s): • Ability to walk unaided (GBS disability score 2) at 8 weeks. • Time taken to improve by at least one grade (on the GBS disability scale). • Time taken to walk independently. • Difference in GBS disability score at maximum disability compared with 6 months. • Percentage of patients with a clinically relevant improvement in R-ODS score defined as an increase from Baseline in R-ODS score by at least 6 points on the centile metric score at 4 weeks and 6 months. • Percentage of patients with a clinically relevant improvement in ONLS defined as an increase from Baseline in ONLS score by at least 1 point at 4 weeks and 6 months. • Requirement for ventilatory support (GBS disability score 5). • Duration of ventilatory support. • Occurrence of relapse. • Death within the first 6 months. ;Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated at each clinical encounter. Significant time points are: Improvements in RODS/ONLS at 4 weeks and 6 months Mobility at 8 weeks. GBS disability score at 6 months Fatality at 6 months (attributable to GBS)	—

Measure

Time frame

Secondary end point(s): • Ability to walk unaided (GBS disability score 2) at 8 weeks. • Time taken to improve by at least one grade (on the GBS disability scale). • Time taken to walk independently. • Difference in GBS disability score at maximum disability compared with 6 months. • Percentage of patients with a clinically relevant improvement in R-ODS score defined as an increase from Baseline in R-ODS score by at least 6 points on the centile metric score at 4 weeks and 6 months. • Percentage of patients with a clinically relevant improvement in ONLS defined as an increase from Baseline in ONLS score by at least 1 point at 4 weeks and 6 months. • Requirement for ventilatory support (GBS disability score 5). • Duration of ventilatory support. • Occurrence of relapse. • Death within the first 6 months. ;Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated at each clinical encounter. Significant time points are: Improvements in RODS/ONLS at 4 weeks and 6 months Mobility at 8 weeks. GBS disability score at 6 months Fatality at 6 months (attributable to GBS)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026