AB-2004 for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism Spectrum Disorder+4 More
AB-2004 - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if AB-2004, a new medication, is safe and effective for treating irritability in teens with autism spectrum disorder.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autoimmune Diseases

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From baseline to Week 8 visit

Week 8
Number of participants who reported treatment emergent adverse events (TEAEs)
The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004 High Dose
The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004 Low Dose
Antibodies

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

AB-2004 Low Dose
1 of 3
AB-2004 High dose
1 of 3
Placebo
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

195 Total Participants · 3 Treatment Groups

Primary Treatment: AB-2004 · Has Placebo Group · Phase 2

AB-2004 High dose
Drug
Experimental Group · 1 Intervention: AB-2004 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
AB-2004 Low Dose
Drug
ActiveComparator Group · 1 Intervention: AB-2004 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to week 8 visit

Who is running the clinical trial?

Axial Therapeutics, Inc.Lead Sponsor

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a clinical global impression - severity (CGI-S) score ≥4 at the screening visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Georgia50.0%
Michigan25.0%
Massachusetts25.0%
How old are they?
< 1850.0%
18 - 6550.0%
What site did they apply to?
Catherine Masters100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria75.0%
Met criteria25.0%