Clinical trial NCT04035135: A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Guillain-Barré Syndrome
Lead sponsor: Annexon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ResearchPoint Global
name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2019-07-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label combination treatment
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AE's
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacokinetics of ANX005 when administered in combination with IVIg
timeFrame: 3 months
measure: Pharmacodynamics of ANX005 when administered in combination with IVIg
timeFrame: 4 months
measure: Values and change from baseline in Guillain-Barré Syndrome Disability Score (GBS-DS) by visit
timeFrame: 6 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: National Institute of Neurosciences and Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Annexon, Inc.
name: Henk-André Kroon, MD, MBA
role: STUDY_DIRECTOR
References: