Xolair Interventional Study in ASD Patients With Comorbid Atopy

• Status: Withdrawn
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Novartis
• Treatments: Omalizumab

Criteria

Inclusion criteria:

• Age between 18-30 years old.

• Clinical diagnosis of ASD during childhood that is still active.

• History of atopic diseases, including asthma, atopic dermatitis, and allergic rhinitis.

• Total serum IgE level ≥ 30 IU/ml and ≤ 400 IU/ml

Exclusion criteria:

• History of omalizumab use.

• Subjects who have used oral or systemic steroid burst within 6 weeks of study enrollment. Subjects who are receiving a maintenance dose of Prednisone of 5 mg/day or less will be allowed provided the dose of Prednisone is not changed during the study.

• Subjects actively taking the antipsychotic medication, Loxapine.

• History of cancer or pre-cancer.

• Subjects with active or unstable seizure disorder.

• History or active signs of psychosis.

• Body weight > 90kg

• For subjects who meet allergic rhinitis inclusion criteria, RCAT >20

• IQ < 70

• Adaptive Behavior Composite score < 90, based on the Vineland 3rd Edition

• Lactating or pregnant females. Xolair has not been sufficiently tested for safe use in pregnant females.

• Subjects who are deemed by the study staff to be unable to cooperate with or understand the instructions that will be given during the study.

• Subjects with severe medical condition(s) that in the view of a Physician Investigator prohibits participation in the study.