drugset / Trial / NCT04535817

Xolair Interventional Study in ASD Patients With Comorbid Atopy

NCT04535817 ↗

NaSingle-groupOpen-labelTreatment

Summary

Following the publication of two case studies that reported behavioral benefit in ASD patients treated with omalizumab, the investigators will conduct a pilot trial to test the proof-of-concept efficacy of omalizumab in ASD patients with comorbid atopic disease. Investigators will evaluate behavioral improvement using three questionnaires. Investigators will also perform fMRI on all subjects and obtain serum samples for quantification of immunological biomarkers. If the trial is conclusive, the investigators will conduct a larger-scale, randomized-controlled trial to further understand the pathology of allergy in this subpopulation of ASD patients and the efficacy of this intervention.

Timeline

Start
2021-01-01
Primary completion
2022-01-01
Completion
2022-01-01

Outcome

Outcome not reported

Stopped (Business): “We are terminating due to loss of funding because of Covid-19.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 300 mg Subcutaneous