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A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)

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: NCT04035135
Recruitment Status : Completed
First Posted : July 29, 2019
Last Update Posted : August 11, 2021
Sponsor:
Collaborators:
ResearchPoint Global
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Annexon, Inc.

Brief Summary:
This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.

Condition or disease Intervention/treatment Phase
Guillain-Barré Syndrome Drug: ANX005 Drug: Intravenous immunoglobulin Phase 1

Detailed Description:
The study will enroll approximately 12 subjects into one cohort, with subjects receiving 75 mg/kg of ANX005, a dose shown to be safe and well-tolerated as monotherapy and that provides a meaningful level of exposure to be tested in combination with IVIg. Dosing of IVIg will be administered as is the current standard of care (0.4 g/kg/day x 5 days) and ANX005 will be administered concurrently, beginning on Day 1 or 2 of the treatment period. Subjects will be followed for 6 months after treatment for observation and evaluation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label combination treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study to Evaluate the Safety, Tolerability and Drug-Drug Interactions of ANX005 and Intravenous Immunoglobulin (IVIg) in Subjects With Guillain Barré Syndrome
Actual Study Start Date : January 29, 2020
Actual Primary Completion Date : May 19, 2021
Actual Study Completion Date : May 19, 2021


Arm Intervention/treatment
Experimental: Open Label Treatment Arm
One (1) dose of ANX005, 75 mg/kg, will be administered IV. IVIg, 0.4 g/kg, will be administered for 5 consecutive Days.
Drug: ANX005
investigational drug
Other Name: Anti C1q Antibody

Drug: Intravenous immunoglobulin
investigational drug
Other Name: IVIg




Primary Outcome Measures :
  1. Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AE's [ Time Frame: 6 months ]
    As measured by incidence of TEAEs, SAEs, AE's related to ANX005, SAE's related to ANX005, Grade 3 or higher AEs, Grade 3 or higher AEs related to ANX005, AEs leading to study or treatment discontinuation.


Secondary Outcome Measures :
  1. Pharmacokinetics of ANX005 when administered in combination with IVIg [ Time Frame: 3 months ]
    As measured by ANX005 serum concentrations

  2. Pharmacodynamics of ANX005 when administered in combination with IVIg [ Time Frame: 4 months ]
    As measured by CH50 and C1q serum concentrations

  3. Values and change from baseline in Guillain-Barré Syndrome Disability Score (GBS-DS) by visit [ Time Frame: 6 months ]
    The 6-point Guillain-Barré Syndrme Disability Score (GBS-DS) is a widely accepted and easily obtainable scoring system used to assess functional status of GBS subjects. The score is as follows: 0 = Healthy, 1 = Minor symptoms and capable of running, 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 = death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain Barré Syndrome
  • Onset of GBS-related weakness ≤14 days prior to infusion
  • GBS-DS score of 3, 4, or 5

Exclusion Criteria:

  • Clinically significant findings that may interfere with the conduct of the study or the interpretation of the data
  • Be at risk of suicide or self-harm
  • Received previous treatment with plasma exchange for GBS
  • Any diagnosis of a variant of GBS
  • Have a history of anaphylaxis or severe systemic response to immunoglobulin
  • Documented, clinically significant, pre-existing polyneuropathy from another cause
  • Clinically significant intercurrent illness, medical condition, or medical history
  • History of chronic use of steroid or immunosuppressant medication
  • Active alcohol, drug, or substance abuse
  • Females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035135


Locations
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Bangladesh
National Institute of Neurosciences and Hospital
Dhaka, Bangladesh
Denmark
Aarhus University Hospital
Aarhus, Denmark
Sponsors and Collaborators
Annexon, Inc.
ResearchPoint Global
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Study Director: Henk-André Kroon, MD, MBA Annexon, Inc.
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Responsible Party: Annexon, Inc.
ClinicalTrials.gov Identifier: NCT04035135    
Other Study ID Numbers: ANX005-GBS-03
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Guillain-Barre Syndrome
Syndrome
Disease
Pathologic Processes
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs