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Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis (ANGEL-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03239860
Recruitment Status : Terminated (Based on R&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.)
First Posted : August 4, 2017
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
Les Laboratoires Servier
Worldwide Clinical Trials
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
GeNeuro SA

Tracking Information
First Submitted Date  ICMJE July 12, 2017
First Posted Date  ICMJE August 4, 2017
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE June 6, 2017
Actual Primary Completion Date November 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Long term safety of GNbAC1 [ Time Frame: 96 Weeks ]
The main parameters evaluated to assess the long term safety will be: AE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
  • Long term efficacy of GNbAC1 in terms of MRI outcomes [ Time Frame: 96 Weeks ]
  • Long term efficacy of GNbAC1 in terms of relapse rate [ Time Frame: 96 Weeks ]
  • Long term efficacy of GNbAC1 in terms of disability [ Time Frame: 96 Weeks ]
  • Long term efficacy of GNbAC1 in terms of disease progression [ Time Frame: 96 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis
Official Title  ICMJE A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
Brief Summary

The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis.

The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE Drug: GNbAC1 Monoclonal Antibody
Monthly IV
Study Arms  ICMJE
  • Experimental: Dose 1 GNbAC1
    Monthly IV
    Intervention: Drug: GNbAC1 Monoclonal Antibody
  • Experimental: Dose 2 GNbAC1
    Monthly IV
    Intervention: Drug: GNbAC1 Monoclonal Antibody
  • Experimental: Dose 3 GNbAC1
    Monthly IV
    Intervention: Drug: GNbAC1 Monoclonal Antibody
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 10, 2018)
220
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2017)
200
Actual Study Completion Date  ICMJE November 14, 2018
Actual Primary Completion Date November 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main 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
  • Provision of written informed consent to participate prior to any trial procedure as shown by signature on the subject consent form.

Main Exclusion Criteria:

  • Patients not having completed the study GNC-003
  • Pregnancy
  • The 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Croatia,   Czechia,   Estonia,   Germany,   Hungary,   Italy,   Poland,   Russian Federation,   Serbia,   Spain,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03239860
Other Study ID Numbers  ICMJE GNC-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GeNeuro SA
Study Sponsor  ICMJE GeNeuro SA
Collaborators  ICMJE
  • Les Laboratoires Servier
  • Worldwide Clinical Trials
  • Institut de Recherches Internationales Servier
Investigators  ICMJE Not Provided
PRS Account GeNeuro SA
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP