TB006 for Autism Spectrum Disorder (NCT06500637) | Clinical Trial Compass
RecruitingPhase 2
TB006 for Autism Spectrum Disorder
United States45 participantsStarted 2024-08-03
Plain-language summary
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.
Who can participate
Age range18 Years – 35 Years
SexALL
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Inclusion criteria
✓. Autism Spectrum Disorder as defined below by the ADOS or ADI-R.
✓. Between 18 and 35 years of age at baseline.
✓. English included in the languages in which the individual is being raised.
✓. Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale.
✓. Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period.
✓. Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry.
✓. In males and females of childbearing age, two forms of birth control must be used unless they are not sexually active.
✓. A caretaker who will accompany the patient to all procedures and has adequate contact with the participant to complete caregiver questionnaires.
Exclusion criteria
✕. LGALS3 rs4644 single nucleotide polymorphism with two copies of the Variant-type allele.
✕. History of infusion reactions to immunoglobulin product.
✕. Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior.
✕. Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill).
✕. Severe prematurity (\<34 weeks gestation) as determined by medical history.
✕. Current uncontrolled gastroesophageal disorders.
✕. Current or history of liver or kidney disease as determined by medical history and safety labs (See Laboratory Values Monitoring Plan for specific laboratory values).