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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 : January 19, 2021
Sponsor:
Collaborators:
ResearchPoint Global
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Annexon, Inc.

Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 29, 2019
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE January 29, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
  • Pharmacokinetics of ANX005 when administered in combination with IVIg [ Time Frame: 3 months ]
    As measured by ANX005 serum concentrations
  • Pharmacodynamics of ANX005 when administered in combination with IVIg [ Time Frame: 4 months ]
    As measured by CH50 and C1q serum concentrations
  • 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
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 A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
Official Title  ICMJE 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
Brief Summary This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open label combination treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Guillain-Barré Syndrome
Intervention  ICMJE
  • Drug: ANX005
    investigational drug
    Other Name: Anti C1q Antibody
  • Drug: Intravenous immunoglobulin
    investigational drug
    Other Name: IVIg
Study Arms  ICMJE 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.
Interventions:
  • Drug: ANX005
  • Drug: Intravenous immunoglobulin
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 26, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shree Martinez 650-822-5514 smartinez@annexonbio.com
Contact: Marta Schumacher 650-822-5507 mschumacher@annexonbio.com
Listed Location Countries  ICMJE United States,   Bangladesh,   Denmark,   Netherlands,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04035135
Other Study ID Numbers  ICMJE ANX005-GBS-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Annexon, Inc.
Study Sponsor  ICMJE Annexon, Inc.
Collaborators  ICMJE
  • ResearchPoint Global
  • International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators  ICMJE
Study Director: Henk-André Kroon, MD, MBA Annexon, Inc.
PRS Account Annexon, Inc.
Verification Date January 2021

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