Xolair Interventional Study in ASD Patients With Comorbid Atopy

NCT ID: NCT04535817

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-01-01

Brief 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.

Detailed Description

This clinical trial is a Phase I, single-arm, open-label study. All 20 subjects will be given the same dosage of the study drug. Following baseline testing, subjects will undergo treatment during a 24 week treatment period and will receive six subcutaneous injections total, one injection every 4 weeks. A 24-week follow-up period after the treatment period will be concluded with patient interview. Behavioral questionnaires will be administered throughout the duration of the trial. fMRI will be conducted at baseline and at the conclusion of the treatment period. Blood will be drawn for serum testing at baseline, at Week 12 during the treatment period, and at the conclusion of the treatment period. Vitals and CGI will also be assessed throughout the trial.

Conditions

Autism Spectrum Disorder; Atopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Subjects will receive subcutaneous treatment of 300mg of omalizumab during the 24-week treatment period. One injection will be administered every 4 weeks.

Group Type: EXPERIMENTAL

Omalizumab Injection [Xolair]

Intervention Type: DRUG

300mg via 2 subcutaneous injections every 4 weeks

Interventions

Omalizumab Injection [Xolair]

300mg via 2 subcutaneous injections every 4 weeks

Intervention Type: DRUG

Other Intervention Names

Xolair

Eligibility 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

• 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Xue-Jun Kong

Research Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xue-Jun Kong, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2020P000753

Identifier Type: -

Identifier Source: org_study_id