TB006 for Autism

Recruiting at 1 trial location

Overseen By Richard E Frye, M.D., PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Rossignol Medical Center

Disqualifiers: Epilepsy, Liver disease, Kidney disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 14 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TB006 for individuals with Autism Spectrum Disorder (ASD). TB006 is a special antibody that targets a protein linked to conditions affecting the brain and nervous system, and it might help manage autism symptoms. Participants will be randomly assigned to receive either TB006 or a placebo (a treatment without the active ingredient) to compare the effects. This trial suits English-speaking adults with moderate or higher severity autism who can maintain their current treatments during the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in autism treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you must keep any complementary, dietary, traditional, and behavioral treatments unchanged for two months before and during the study.

Is there any evidence suggesting that TB006 is likely to be safe for humans?

Research has shown that TB006 is a specially designed protein made in a lab. It targets and attaches to a specific protein in the body called Galectin-3, which is linked to various health issues, including some affecting the brain. In earlier studies, about 5.17% of participants experienced serious side effects, but these were not attributed to TB006. This suggests that TB006 was generally well tolerated. Additionally, the FDA has approved TB006 for compassionate use, indicating that early safety data is promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for autism?

Unlike the standard treatments for autism, which often focus on behavioral therapies and medications like antipsychotics, TB006 acts on a different target altogether. TB006 is a monoclonal antibody specifically designed to bind to the Galectin-3 protein, which has been found at elevated levels in individuals with autism spectrum disorder (ASD). This unique mechanism of targeting Galectin-3 could potentially address underlying neuroinflammatory pathways, offering a novel approach to treatment. Researchers are excited about TB006 because it represents a fresh angle in tackling autism, potentially leading to new breakthroughs in how we understand and manage the condition.

What evidence suggests that TB006 might be an effective treatment for autism?

Research has shown that TB006, which participants in this trial may receive, could be a promising treatment for Autism Spectrum Disorder (ASD). TB006 is a lab-made protein known as a monoclonal antibody, designed to attach to specific substances in the body. It targets a protein called Galectin-3, often found in higher amounts in people with ASD. By attaching to Galectin-3, TB006 might help reduce some autism symptoms. Early studies suggest this method could be effective, but further research is needed to confirm its benefits. ^{1 2 3 5 6}

Who Is on the Research Team?

Richard E Frye, M.D., Ph.D

Principal Investigator

Rossignol Medical Center

Daniel A Rossignol, MD

Principal Investigator

Rossignol Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English included in the languages in which the individual is being raised

I haven't changed my non-medical treatments in the last 2 months.

A caretaker who will accompany the patient to all procedures and has adequate contact with the participant to complete caregiver questionnaires

Exclusion Criteria

Congenital brain malformations

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive TB006 or placebo treatment in a double-blind manner

14 weeks

Multiple visits (in-person)

Open-label extension

Placebo subjects receive TB006 treatment in an open-label manner

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TB006

Trial Overview 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.

How Is the Trial Designed?

Group I: TB006 Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Identical IV solution without TB006 product

Who Is Running the Clinical Trial?

Rossignol Medical Center

Lead Sponsor

Trials

6

Recruited

780+

Autism Discovery and Treatment Foundation

Collaborator

Trials

2

Recruited

1,000+

Published Research Related to This Trial

Emerging evidence suggests that elevated levels of interleukin (IL)-6 in the brain, potentially due to activated glia or maternal immune activation, may contribute to autism-like behaviors by affecting brain structure and neuronal plasticity.

This review highlights the potential of targeting IL-6 as a pharmacological intervention for autism, indicating that further research could be significant in developing new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain IL-6 and autism. Wei, H., Alberts, I., Li, X.[2013]

Mice with elevated levels of IL-6 in the brain exhibited several behaviors associated with autism, such as cognitive impairments, anxiety, and reduced social interactions, indicating a potential link between IL-6 and autistic features.

The study suggests that elevated IL-6 may disrupt the balance of excitatory and inhibitory synaptic transmissions and alter dendritic spine structures, which could contribute to the development of autism-like behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain IL-6 elevation causes neuronal circuitry imbalances and mediates autism-like behaviors. Wei, H., Chadman, KK., McCloskey, DP., et al.[2016]

Several treatments for autism spectrum disorders (ASD) have been identified, with melatonin, acetylcholinesterase inhibitors, naltrexone, and music therapy receiving a 'Grade A' recommendation, indicating strong support from clinical trials.

Despite the promising nature of these treatments, all are currently considered off-label for ASD, highlighting the need for further research and the importance of physicians discussing unconventional treatments with their patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel and emerging treatments for autism spectrum disorders: a systematic review. Rossignol, DA.[2018]

Over the past 40 years, significant advancements in neuroimmunology have led to the development of effective disease-modifying therapies (DMTs) for multiple sclerosis (MS), improving patient outcomes and reducing disease burden.

Enhanced diagnostic criteria, disability assessment scales, imaging techniques, and biomarkers have contributed to a deeper understanding of MS, paving the way for more targeted and effective treatments in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials in multiple sclerosis: past, present, and future. Manouchehri, N., Shirani, A., Salinas, VH., et al.[2022]

A systematic review of 226 randomized controlled trials (RCTs) on disease-modifying therapies (DMT) for relapsing forms of multiple sclerosis (RMS) revealed that 89% reported clinical efficacy outcomes, highlighting the importance of these measures in evaluating treatment effectiveness.

The study identified significant variability in the definitions of clinical outcomes, with 77 different outcomes and 36 definitions for 'relapse', indicating a need for standardized measures to improve consistency in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy outcomes reported in trials of multiple sclerosis: A systematic scoping review. Oliveira, ML., Lucchetta, RC., Bonetti, AF., et al.[2021]

In a study involving 1000 patients with relapsing forms of multiple sclerosis, switching to teriflunomide from other disease-modifying therapies significantly increased treatment satisfaction scores across various reasons for switching, indicating a positive impact on patient experience.

Patients who switched to teriflunomide also showed stability or improvement in measures of disability, cognition, and quality of life, while the safety profile remained consistent with previous clinical trials, suggesting that teriflunomide is a well-tolerated option for MS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in patients with relapsing forms of MS switching to teriflunomide from other disease-modifying therapies: Results from the global Phase 4 Teri-PRO study in routine clinical practice. Coyle, PK., Khatri, B., Edwards, KR., et al.[2021]

In Stockholm, Sweden, the prevalence of diagnosed autism spectrum disorders (ASD) in 2011 was found to be 0.40% in children aged 0-5 years and increased to 1.76% in young adults aged 18-27, indicating a significant rise in diagnoses across age groups.

Between 2001 and 2011, the prevalence of ASD among children aged 2-17 years increased nearly 3.5 times, primarily due to an eightfold rise in cases of ASD without intellectual disability, suggesting that factors like improved awareness and diagnostic practices may have contributed to this increase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in prevalence of autism spectrum disorders in 2001-2011: findings from the Stockholm youth cohort. Idring, S., Lundberg, M., Sturm, H., et al.[2022]

Adults with autism spectrum disorders (ASD) have significantly higher rates of prescription drug use and polypharmacy compared to adults without ASD, with nearly 75% of those with ASD having over 20 prescription drug claims annually.

The study found that 85% of adults with ASD used at least one psychotropic medication, with common prescriptions including antipsychotics and anticonvulsants, highlighting the need for careful monitoring of treatment efficacy and safety due to the high rates of polypharmacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis. Vohra, R., Madhavan, S., Sambamoorthi, U., et al.[2020]

The study evaluated the effectiveness of an electronic monitoring device combined with behavioral feedback to improve adherence to multiple sclerosis therapies in young patients.

The trial was randomized, indicating a robust design to assess the impact of these interventions on treatment adherence, although specific results and participant numbers are not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction to: Impact of an electronic monitoring device and behavioural feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial. Yeh, EA., Grover, SA., Powell, VE., et al.[2019]

In a long-term study involving 86 pediatric patients with autistic disorder, aripiprazole was found to be generally safe and well-tolerated, with most side effects being mild or moderate, such as nasopharyngitis and somnolence.

After 48 weeks of treatment, aripiprazole significantly reduced irritability symptoms, with a mean change of -6.3 in patients previously on placebo, indicating its efficacy in managing irritability associated with autism spectrum disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan. Ichikawa, H., Hiratani, M., Yasuhara, A., et al.[2019]

Ofatumumab, an anti-CD20 monoclonal antibody approved for relapsing multiple sclerosis, was prescribed to 2,101 patients in a study that highlighted its increasing use as a first-line disease-modifying therapy, particularly among DMT-naïve patients, who made up a growing percentage of users over time.

The study found that the majority of patients were middle-aged women with mild MS symptoms, and many patients aged 55 and older were also treated with ofatumumab, suggesting a growing confidence in its safety and effectiveness beyond the initial trial population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world use of ofatumumab to treat multiple sclerosis 9 months post-FDA approval during COVID-19 pandemic. Coyle, PK., Gorritz, M., Wade, RL., et al.[2023]

Systemic treatment with IL-6 receptor antibodies (IL-6R ab) significantly reduced the development and frequency of seizures in Synapsin 2 knockout (Syn2 KO) mice when administered before the onset of seizures, indicating a potential therapeutic window for intervention.

However, early IL-6R ab treatment did not reverse neuroinflammatory changes or improve behavioral aspects related to autism spectrum disorder, suggesting that while IL-6 signaling is involved in epilepsy development, it may not directly influence cognitive or mood-related symptoms in this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced epilepsy development in synapsin 2 knockout mice with autistic behavior following early systemic treatment with interleukin-6 receptor antibody. Bäckström, F., Ahl, M., Wickham, J., et al.[2023]

The prevalence of Autism Spectrum Disorder (ASD) has increased to about 1 in 36 children, with various hereditary and environmental factors linked to a higher risk of developing the condition.

Both pharmacological treatments (like atypical antipsychotics and antidepressants) and non-pharmacological interventions (such as cognitive behavioral therapy and music therapy) are available for managing ASD symptoms, with ongoing research into novel therapies for more effective long-term solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autism Spectrum Disorder: Classification, diagnosis and therapy. Sharma, SR., Gonda, X., Tarazi, FI.[2022]

In a 52-week study involving 58 Asian children and adolescents with autistic disorder, aripiprazole significantly improved behavioral issues and adaptive functioning, as measured by various scales including the Aberrant Behavior Checklist and Clinical Global Impression scale.

While 58.62% of participants experienced treatment-emergent adverse events, the most common were mild (nasopharyngitis and weight gain), and serious adverse events were rare, indicating that aripiprazole is generally well tolerated over long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Improvement and Safety of Aripiprazole for Irritability and Adaptive Function in Asian Children and Adolescents with Autistic Disorder: A 52-Week, Multinational, Multicenter, Open-Label Study. Kim, BU., Kim, HW., Park, EJ., et al.[2022]

A study involving 71 adults with autism spectrum disorder (ASD) found that genotyping the CYP2D6 enzyme can help predict drug tolerability and prevent adverse reactions to medications like risperidone and aripiprazole.

Participants with the intermediate (IM) CYP2D6 phenotype experienced the highest rates of neurological and psychiatric adverse events, especially when taking multiple medications, highlighting the importance of personalized medicine in managing ASD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CYP2D6 Genotype and Pharmacovigilance Impact on Autism Spectrum Disorder: A Naturalistic Study with Extreme Phenotype Analysis. Ballester, P., Espadas, C., Almenara, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06500637

NCT06500637 | TB006 for Autism Spectrum Disorder 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).

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/542736

TB006 for Autism Spectrum Disorder TB006 is a humanized immunoglobulin G4 (IgG4) (S228P) type monoclonal antibody that is highly specific and has a high affinity to human Galectin ...

3. withpower.com withpower.com/trial/phase-2-autism-spectrum-disorder-7-2024-9fbb5

TB006 for Autism · Recruiting Participants for Phase ... Trial Overview The study tests TB006's effectiveness compared to a placebo in treating Autism Spectrum Disorders. It's designed as a double-blind, meaning ...

4. delta.larvol.com delta.larvol.com/Products/?ProductId=fee76381-67b0-42d0-80fc-f1830a0f91c4

TB006 / TrueBinding TB006, a new investigational drug, has been approved by the US Food and Drug Administration (FDA) for compassionate use and is currently being evaluated in a ...

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/tb-006-truebinding-autism-spectrum-disorder-asd-likelihood-of-approval/

TB-006 by TrueBinding for Autism Spectrum Disorder (ASD) TB-006 is under development for the treatment of Alzheimer's diseases, acute ischemic stroke, autism spectrum disorder (ASD), Parkinson's ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06500637/

Trial | NCT06500637 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).