FAQs

The clinical trial is researching an experimental treatment, AB-2004, that is designed to adsorb specific substances produced by bacteria in the gut and reduce their levels circulating in the bloodstream. Scientific studies have shown that types of bacteria in the gut produce substances that may contribute to certain characteristics, such as irritability, in children with Autism Spectrum Disorder (ASD). The purpose of this study is to learn if the study medication may help improve irritability in children compared to placebo. The study is seeking participants between the ages of 5 and 17 who have been diagnosed with ASD and are experiencing irritability to enroll in this clinical trial. The study aims to show that lowering the levels of these substances can improve irritability in children with ASD.

The clinical trial is being conducted on behalf of Axial Therapeutics by by multiple sites (research clinics or hospitals) in the United States, Australia and New Zealand with trained and qualified medical specialists. Axial is a pharmaceutical company dedicated to improving the lives of people with neurological conditions.

AB-2004 is an experimental therapy that is being developed as a potential treatment for irritability associated with autism. AB-2004, which is a powder, selectively adsorbs certain substances produced by bacteria in the gut before they enter the bloodstream and reach the brain. It is taken by mouth 3 times per day; is tasteless and odorless; and is mixed with any soft food your child may like such as yogurt or apple sauce. AB-2004 was shown to be safe and well tolerated in a previous study involving adolescents with ASD. AB-2004 is an experimental treatment and not currently approved in the United States, Australia and New Zealand. Eligible participants will be randomly assigned to receive either AB-2004 or placebo.

The TAPESTRY Study is “placebo-controlled” which indicates that it includes a placebo. There is a chance that the medication your child receives is a placebo, which is a harmless substance that looks identical to the treatment being tested in the clinical trial. Placebos are an important part of clinical research and are used as a control group to compare the real study’s drug effects.

No. If you qualify and are chosen to participate, you will receive all study-related care, including the investigational drug and all assessments at no cost to you. Insurance is not required.

The TAPESTRY Autism Study will enroll about 140 participants with autism spectrum disorder at study centers throughout the US.

If your child qualifies, participation in this study will last approximately 14-16 weeks.

Like all clinical trials, participation is fully voluntary. Your child may leave the study at any time.

When your child becomes a participant, the study doctor will administer the medication to your child at the clinic and conduct examinations and testing. You will be required to give additional doses of the study medication to their child at home, collect urine and stool samples, and answer questions about your child’s behavior.

Axial has a rigorous selection process that all clinical trial sites must successfully complete prior to being a part of this study. The selection process includes an evaluation of the site’s COVID-19 management practices to ensure that the risk of exposure to COVID-19 is limited.

Detailed information about the clinical trial can be found at: https://clinicaltrials.gov/ct2/show/NCT04895215

Start by completing the pre-screening questionnaire to better understand the eligibility criteria for your child’s participation in the study. In the US please visit https://trial.autocruitment.com/TAPESTRY/tpsr and in Australia and New Zealand please visit https://trial.autocruitment.com/TAPESTRY/tpsr/AU-NZ/.