Multisite 14-week prospective double-blind placebo controlled parallel-group randomized clinical trial with 14-week open-label extension at the end of double-blind treatment phase for placebo subjects. Eligible subjects will be randomized within each site in 2:1 ratio to receive either TB006 or placebo treatment.
A key molecular mechanism implicated in ASD is immune dysregulation and unchecked neuroinflammation marked by increased microglial activation. Galectin-3 (Gal-3), a galactoside-binding lectin, is critical to activation of neuroinflammation resulting in the proliferation of microglia.7 Gal-3 has been shown to be elevated in individuals with ASD. To inhibit Gal-3's contribution to neuroinflammation, Truebinding has developed TB006, a neutralizing monoclonal antibody against Gal-3. Our overall hypothesis is that TB006 will significantly improve core and associated behavioral symptoms of ASD and be well tolerated with no significant adverse effects in adults with ASD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
TB006 is a humanized immunoglobulin G4 (IgG4) (S228P) type monoclonal antibody that is highly specific and has a high affinity to human Galectin-3 (hGal-3).
Rossignol Medical Center
Phoenix, Arizona, United States
RECRUITINGRossignol Medical Center
Aliso Viejo, California, United States
RECRUITINGChildhood Autism Rating Scores (CARS)
The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.
Time frame: Baseline, Week 8 and Week 14
NIH Toolbox
The NIH ToolBox is a set of short assessments for neurodevelopmental assessments. Direction of score depends on individual subtest.
Time frame: Baseline and Week 14
Clinical Global Impression Scale (CGI)
The CGI measures the overall disease severity and change. It is completed by a clinician. Scores range from 1 to 7. Lower score is better
Time frame: Baseline, Week 8 and Week 14
Social Responsiveness Scale (SRS)
The SRS is a caregiver report of autism symptoms Lower Score is Better, Scores range from 30 to 90 (T-scores)
Time frame: Baseline, Week 8, Week 12 and Week 14
Aberrant Behavior Checklist (ABC)
The ABC is a 58-item consisting five subscales: hyperactivity, irritability, social withdrawal, stereotypic behavior and inappropriate speech in children with developmental disabilities. A higher score indicates more frequent aberrant behaviors.
Time frame: Screening, Weeks 4, 8, 12 and 14
Major Parental Concerns
The parent nominates 2 most problematic symptoms. Responses are documented in a standardized format documenting frequency, intensity, and impact of behavior. The overall severity is rated using a CGI type scale.
Time frame: Baseline, Week 8, Week 12 and Week 14
Ohio State University Clinical Impressions Scale
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a clinical rating of severity and improvement of 10 autism domains: social interaction, aberrant/abnormal behavior, repetitive/ritualistic behavior, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety/fears, sensory sensitivities, restricted/narrow interests, autism. Severity will be measured at baseline. Each item is rated from 1 (Normal) to 7 (Among the most severe) with a raw score range of 10-70. The raw score will be reported. Higher scores indicate more severe impairment. At the following time points, improvement will be measured. Each item is rated from 1 (Very much improved) to 7 (Very much worse) with a raw score range of 10-70. The raw score will be reported. Higher scores indicate more severe impairment.
Time frame: Baseline and Week 14
Vineland Adaptive Behavior Scale
A scale to assess adaptive behavior in children with developmental/intellectual disabilities. This is a 135-item parent-reported measure with ratings in the following domains: communication, daily living skills, and socialization. The frequency of each item is scaled from 0 (Never) to 2 (Usually). For each domain, there are 45 items with a maximum score of 90. Change in each domain will be measured by the change in standard score. Standard scores are calculated from the raw scores and based on age norms. A higher standard score in any domain indicates a higher level of adaptive behavior in that domain. Domain standard scores will be used to get a standard composite score. Change in adaptive behavior will be measured by the change in the standard score. A higher composite score indicates higher overall adaptive behavior ability.
Time frame: Baseline, Week 8 and Week 14