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TB006 for Autism

Phase 2

Recruiting

Led By Daniel A Rossignol, MD

Research Sponsored by Rossignol Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 18 and 35 years of age at baseline

Be between 18 and 65 years old

Must not have

Genetic syndromes

Severe prematurity (<34 weeks gestation) as determined by medical history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, weeks 4, 8, 12 and 14

Summary

This trial will last for 14 weeks and will be done at multiple locations. It will be double-blind, meaning neither the participants nor the researchers will know who is receiving the real treatment or the placebo

Who is the study for?

This trial is for individuals with Autism Spectrum Disorder. Participants should be able to attend multiple site visits over a 14-week period and are willing to potentially continue in an open-label extension phase.

What is being tested?

The study tests TB006's effectiveness compared to a placebo in treating Autism Spectrum Disorders. It's designed as a double-blind, meaning neither the participants nor the researchers know who gets what treatment until after the results are collected.

What are the potential side effects?

Since specific side effects of TB006 aren't provided, they may range from none to mild or severe, depending on individual reactions. Common drug-related side effects could include nausea, headaches, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a diagnosed genetic syndrome.

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I was born severely premature, before 34 weeks of pregnancy.

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I have uncontrolled stomach or esophagus problems.

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I have a specific genetic variation related to LGALS3.

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My condition is extremely severe.

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I am not taking any medications that would interfere with the study drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, weeks 4, 8, 12 and 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, weeks 4, 8, 12 and 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, weeks 4, 8, 12 and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Childhood Autism Rating Scores (CARS)

Secondary study objectives

Aberrant Behavior Checklist (ABC)

Clinical Global Impression Scale (CGI)

Major Parental Concerns

+4 more

Other study objectives

Galectin-3 levels

Side effects data

From 2022 Phase 1 & 2 trial • 154 Patients • NCT05074498

14%

Blood urea increased

14%

Thyroid function test abnormal

14%

Pyrexia

14%

Gastroenteritis

14%

Sinus tachycardia

14%

Nausea

14%

Asthenia

14%

Fatigue

14%

COVID-19

14%

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

Part 2: Placebo

Part 1: TB006 140 Milligrams (mg) Weekly (qw)

Part 1: Placebo

Part 1: TB006 420 mg qw

Part 2: TB006 1000 mg qw

Part 1: TB006 1000 mg qw

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TB006Experimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

Identical IV solution without TB006 product

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TB006

2021

Completed Phase 2

~160

0 / 7Eligibility criteria met