A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis

A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004935-18-HU

Enrollment

240

Registered

2017-02-02

Start date

2017-04-12

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Multiple Sclerosis (MS) MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: GNbAC1 Product Code: GNbAC1 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Not Available CAS Number: 1393641-34-3 Current Sponsor code: GNbAC1 Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study; - Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients not having completed study GNC-003. - Emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient’s neurological signs and symptoms. - Any major medical or psychiatric disorder that could put the patient at undue risk during the study, according to the investigator’s opinion, or that would affect the capacity of the patient to fulfill the requirements of the study, including: Schizophrenia, bipolar disorder, or major depressive disorder, History of suicide attempt, or current suicidal ideation, current alcohol or drug abuse. - Body weight<40kg - Patients not able to follow study instructions, or not able to follow the study assessments defined by the protocol. - Forbidden concomitant treatments - Legal incapacity or limited legal capacity. - Pregnancy. - Female patients of childbearing potential (FPCBP) or procreative male patients (PMP), not willing to use highly effective contraceptive methods throughout the study duration and at least until 5 months after the last study treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the long term safety of GNbAC1 in patients with RRMS.;Secondary Objective: The secondary objectives are to assess the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.;Primary end point(s): The following parameters will be evaluated to assess the long term safety of GNbAC1: - Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs); - Clinical safety laboratory (Haematology, Chemistry, Coagulation), urinalysis and pregnancy urinary test; - IgG4 dosing; - Physical examination and vital signs: Blood pressure, heart rate, temperature, and body weight; - 12-lead ECG; - Human anti-GNbAC1 antibodies in serum; - Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS).;Timepoint(s) of evaluation of this end point: - AEs at each visit; SAEs at any time -Laboratory parameters and urinalysis every 6 months and urine pregnancy test at each study visit - Physical examination and vital signs at selection and at each study visit - C-SSRS at every visit - ECG and human anti-GNbAC1 antibodies every 6 months - IgG4 at baseline, W48 and W96	—

Measure

Time frame

Main Objective: The primary objective is to assess the long term safety of GNbAC1 in patients with RRMS.;Secondary Objective: The secondary objectives are to assess the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.;Primary end point(s): The following parameters will be evaluated to assess the long term safety of GNbAC1: - Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs); - Clinical safety laboratory (Haematology, Chemistry, Coagulation), urinalysis and pregnancy urinary test; - IgG4 dosing; - Physical examination and vital signs: Blood pressure, heart rate, temperature, and body weight; - 12-lead ECG; - Human anti-GNbAC1 antibodies in serum; - Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS).;Timepoint(s) of evaluation of this end point: - AEs at each visit; SAEs at any time -Laboratory parameters and urinalysis every 6 months and urine pregnancy test at each study visit - Physical examination and vital signs at selection and at each study visit - C-SSRS at every visit - ECG and human anti-GNbAC1 antibodies every 6 months - IgG4 at baseline, W48 and W96

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Secondary

Measure	Time frame
Secondary end point(s): The following parameters will be evaluated to assess the long term efficacy of GNbAC1: - Brain MRI markers of inflammation, disease progression, demyelination and remyelination; - Annualized relapse rate; - Proportion of patients with confirmed neurological disability worsening (defined as an increase of = 1.5 step on the EDSS for EDSS= 0; increase of = 1 step on the EDSS from EDSS > 0 and < 5.5; and =0.5 EDSS steps from EDSS = 5.5, confirmed after at least 3 months at scheduled clinic visits) - Proportion of patients with confirmed neurological disability improvement (defined as a decrease of at least 1 step on the EDSS from EDSS =1 and < 5.5and decrease of at least 0.5 EDSS steps from EDSS = 5.5, confirmed after at least 3 months at scheduled clinic visits) - Proportion of patients with No Evidence of Disease Activity (NEDA, defined as absence of new T1 or T2 lesions on MRI scan, absence of relapse and absence of confirmed disability worsening at Week 48 and 96); - Time to confirmed neurological disability worsening (as defined above); - Time to confirmed neurological disability improvement (as defined above); - Mean change in EDSS Step from baseline in GNC-003 study; - Mean change in MSFC scores (including subcomponent scores) from baseline in GNC-003 study. ;Timepoint(s) of evaluation of this end point: - Brain MRI at Weeks 48 and 96 - Annualized relapse rate at Weeks 48 and 96 - EDSS and MSFC at Weeks 24, 48, 72 and 96 - Proportion of patients with confirmed neurological disability worsening or improvement from baseline in GNC-003 study to weeks 24, 48, 72 and 96	—

Measure

Time frame

Secondary end point(s): The following parameters will be evaluated to assess the long term efficacy of GNbAC1: - Brain MRI markers of inflammation, disease progression, demyelination and remyelination; - Annualized relapse rate; - Proportion of patients with confirmed neurological disability worsening (defined as an increase of = 1.5 step on the EDSS for EDSS= 0; increase of = 1 step on the EDSS from EDSS > 0 and < 5.5; and =0.5 EDSS steps from EDSS = 5.5, confirmed after at least 3 months at scheduled clinic visits) - Proportion of patients with confirmed neurological disability improvement (defined as a decrease of at least 1 step on the EDSS from EDSS =1 and < 5.5and decrease of at least 0.5 EDSS steps from EDSS = 5.5, confirmed after at least 3 months at scheduled clinic visits) - Proportion of patients with No Evidence of Disease Activity (NEDA, defined as absence of new T1 or T2 lesions on MRI scan, absence of relapse and absence of confirmed disability worsening at Week 48 and 96); - Time to confirmed neurological disability worsening (as defined above); - Time to confirmed neurological disability improvement (as defined above); - Mean change in EDSS Step from baseline in GNC-003 study; - Mean change in MSFC scores (including subcomponent scores) from baseline in GNC-003 study. ;Timepoint(s) of evaluation of this end point: - Brain MRI at Weeks 48 and 96 - Annualized relapse rate at Weeks 48 and 96 - EDSS and MSFC at Weeks 24, 48, 72 and 96 - Proportion of patients with confirmed neurological disability worsening or improvement from baseline in GNC-003 study to weeks 24, 48, 72 and 96

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Countries

Bulgaria, Croatia, Czech Republic, Estonia, Germany, Hungary, Italy, Poland, Russian Federation, Serbia, Spain, Ukraine

Contacts

Public ContactProject Management

Worldwide Clinical Trials Ltd

+441159567711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 14, 2026