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Trial record 1 of 1 for:    04035135
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A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)

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ClinicalTrials.gov Identifier: NCT04035135
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : February 13, 2020
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 Phase 2

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)
Estimated Enrollment : 24 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
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 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


Contacts
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Contact: Shree Martinez 650-822-5514 smartinez@annexonbio.com
Contact: Marta Schumacher 650-822-5507 mschumacher@annexonbio.com

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Shree Martinez    650-822-8214    smartinez@annexonbio.com   
United States, Massachusetts
Lahey Hospital & Medical Center Recruiting
Boston, Massachusetts, United States, 01805
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
United States, Minnesota
University of Minnesota Medical School Not yet recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
United States, Pennsylvania
Temple Neurosciences Center, Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
United States, Texas
The University of Texas Health Science Center Houston Recruiting
Houston, Texas, United States, 77030
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
United States, Vermont
University of Vermont Medical Center Not yet recruiting
Burlington, Vermont, United States, 05401
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
Bangladesh
National Institute of Neurosciences and Hospital Recruiting
Dhaka, Bangladesh
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
Netherlands
Erasmus University Medical Center Not yet recruiting
Rotterdam, Netherlands
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
United Kingdom
Glasgow Biomedical Research Center Not yet recruiting
Glasgow, United Kingdom
Contact: Shree Martinez    650-822-5514    smartinez@annexonbio.com   
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: February 13, 2020
Last Verified: February 2020
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