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

• Register: EUCTR
• Last refreshed on: 15 October 2018
• Main ID: EUCTR2016-004935-18-ES
• Date of registration: 10/03/2017
• Prospective Registration: Yes
• Primary sponsor: GeNeuro SA
• Public title: A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis
• Scientific title: A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS
• Date of first enrolment: 24/03/2017
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004935-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: No Comparator; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Project Management
• Affiliation: Worldwide Clinical Trials Ltd

• Name: Project Management
• Affiliation: Worldwide Clinical Trials Ltd

Key inclusion & exclusion 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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Multiple Sclerosis (MS)
MedDRA version: 19.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

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 milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: The primary objective is to assess the long term safety of GNbAC1 in patients with RRMS.

Timepoint(s) of evaluation of this end point: - AEs at each visit; SAEs at any time
- Laboratory parameters 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

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) and urine pregnancy 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).

Secondary Outcome(s)

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);
- EDSS change from baseline in GNC-003 study;
- MSFC scores (including subcomponent scores) change from baseline in GNC-003 study.

Timepoint(s) of evaluation of this end point: - Brain MRI at Weeks 48 and 96
- Annualized relapse rate from baseline in GNC-003 to Weeks 48 and from weeks 48 to weeks 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

Secondary ID(s)

GNC-004

2016-004935-18-HU

Source(s) of Monetary Support

GeNeuro SA