TB006 for Autism Spectrum Disorder

NCT06500637 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TB-RMC
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Childhood 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.

  Baseline, Week 8 and Week 14

Secondary Outcomes (7)

• NIH Toolbox

  Baseline and Week 14

• Clinical Global Impression Scale (CGI)

  Baseline, Week 8 and Week 14

• Social Responsiveness Scale (SRS)

  Baseline, Week 8, Week 12 and Week 14

• Aberrant Behavior Checklist (ABC)

  Screening, Weeks 4, 8, 12 and 14

• Major Parental Concerns

  Baseline, Week 8, Week 12 and Week 14

Other Outcomes (1)

• Galectin-3 levels

  Baseline and Week 14

Study Arms (2)

TB006

EXPERIMENTAL

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). Galectins are a ubiquitous group of proteins found in a variety of cells, tissues, and extravascular spaces, and are involved in numerous metabolic processes and functions. The galectins preferentially bind to β-galactoside derivatives and can cross-link surface glycoproteins by binding galactose residues. The Gal-3 protein plays an important role in different pathogenic conditions, including neurodegenerative and neuroinflammatory disorders. Serum levels of Gal-3 have been found to be elevated in ASD.

Drug: TB006

Placebo

PLACEBO COMPARATOR

Identical IV solution without TB006 product

Drug: TB006

Interventions

TB006 DRUG

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).

Placebo; TB006

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Genetic syndromes.
• Congenital brain malformations.
• Active Epilepsy Diagnosis (Epilepsy Diagnosis is defined as History of two or more unprovoked seizures; Patient with a history of epilepsy who have been off medication without seizures for more than two years do not qualify as active epilepsy).
• Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
• Significant negative reaction (i.e., fainting, vomiting, etc.) because of a previous blood draw.
• Failure to thrive or \< 5%ile for Body Mass Index or weight at the time of screening.
• Concurrent treatment with drug that would significantly interact with the investigational product.
• Allergy or Sensitivity to ingredients in the investigational product or placebo.

Sponsors & Collaborators

• Rossignol Medical Center: lead
• Autism Discovery and Treatment Foundation: collaborator

Study Sites (2)

Rossignol Medical Center

Phoenix, Arizona, 85050, United States

RECRUITING

Rossignol Medical Center

Aliso Viejo, California, 92656, United States

RECRUITING

Related Publications (4)

• Rodriguez JI, Kern JK. Evidence of microglial activation in autism and its possible role in brain underconnectivity. Neuron Glia Biol. 2011 May;7(2-4):205-13. doi: 10.1017/S1740925X12000142. Epub 2012 Jul 6.

  PMID: 22874006 BACKGROUND

• Garcia-Revilla J, Boza-Serrano A, Espinosa-Oliva AM, Soto MS, Deierborg T, Ruiz R, de Pablos RM, Burguillos MA, Venero JL. Galectin-3, a rising star in modulating microglia activation under conditions of neurodegeneration. Cell Death Dis. 2022 Jul 20;13(7):628. doi: 10.1038/s41419-022-05058-3.

  PMID: 35859075 BACKGROUND

• Wang X, Zhang S, Lin F, Chu W, Yue S. Elevated Galectin-3 Levels in the Serum of Patients With Alzheimer's Disease. Am J Alzheimers Dis Other Demen. 2015 Dec;30(8):729-32. doi: 10.1177/1533317513495107. Epub 2013 Jul 2.

  PMID: 23823143 BACKGROUND

• Artik A, Kocaman O, Kara H, Tuncer SC. Galectin-3 levels in school aged children with autism spectrum disorder. Int J Dev Disabil. 2022 Dec 1;69(5):757-761. doi: 10.1080/20473869.2022.2150035. eCollection 2023.

  PMID: 37547549 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

TB006

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Richard E Frye, M.D., Ph.D

  Rossignol Medical Center

  STUDY DIRECTOR

• Daniel A Rossignol, MD

  Rossignol Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alina Espinoza

CONTACT

844-ADTF-Research; info@autismdiscovery.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: August 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)