Back to resultsXolair Interventional Study in ASD Patients With Comorbid Atopy
Primary Purpose
Autism Spectrum Disorder, Atopy
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omalizumab Injection [Xolair]
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring omalizumab
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
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.
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Subjects will receive subcutaneous treatment of 300mg of omalizumab during the 24-week treatment period. One injection will be administered every 4 weeks.
Outcomes
Primary Outcome Measures
Change from Baseline to Week 12 in Social Responsiveness Scale (SRS) Edition 2
Social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Change from Baseline to Week 24 in Social Responsiveness Scale (SRS) Edition 2
Social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Change from Baseline to Week 48 in Social Responsiveness Scale (SRS) Edition 2
Social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Change from Week 24 to Week 48 in Social Responsiveness Scale (SRS) Edition 2
Social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Change from Baseline to Week 12 in Aberrant Behavior Checklist (ABC)
Social behavior test - The total score is calculated based on 5 sub-scales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). There are 58 questions that are scored on a 0-3 scale 0 -"not at all a problem", 1- "the behavior is a problem but slight in degree", 2- "the problem is moderately serious" and 3- "the problem is severe in degree". Based on this sub-scores are calculated and added to get the total score.
Change from Baseline to Week 24 in Aberrant Behavior Checklist (ABC)
Social behavior test - The total score is calculated based on 5 sub-scales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). There are 58 questions that are scored on a 0-3 scale 0 -"not at all a problem", 1- "the behavior is a problem but slight in degree", 2- "the problem is moderately serious" and 3- "the problem is severe in degree". Based on this sub-scores are calculated and added to get the total score.
Change from Baseline to Week 48 in Aberrant Behavior Checklist (ABC)
Social behavior test - The total score is calculated based on 5 sub-scales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). There are 58 questions that are scored on a 0-3 scale 0 -"not at all a problem", 1- "the behavior is a problem but slight in degree", 2- "the problem is moderately serious" and 3- "the problem is severe in degree". Based on this sub-scores are calculated and added to get the total score.
Change from Week 24 to Week 48 in Aberrant Behavior Checklist (ABC)
Social behavior test - The total score is calculated based on 5 sub-scales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). There are 58 questions that are scored on a 0-3 scale 0 -"not at all a problem", 1- "the behavior is a problem but slight in degree", 2- "the problem is moderately serious" and 3- "the problem is severe in degree". Based on this sub-scores are calculated and added to get the total score.
Change from Baseline to Week 1 in Autism Treatment Evaluation Checklist (ATEC)
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Change from Baseline to Week 4 in Autism Treatment Evaluation Checklist (ATEC)
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Change from Baseline to Week 8 in Autism Treatment Evaluation Checklist (ATEC)
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Change from Baseline to Week 12 in Autism Treatment Evaluation Checklist (ATEC)
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Change from Baseline to Week 16 in Autism Treatment Evaluation Checklist (ATEC)
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Change from Baseline to Week 20 in Autism Treatment Evaluation Checklist (ATEC)
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Change from Baseline to Week 24 in Autism Treatment Evaluation Checklist (ATEC)
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Change from Baseline to Week 48 in Autism Treatment Evaluation Checklist (ATEC)
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Change from Week 24 to Week 48 in Autism Treatment Evaluation Checklist (ATEC)
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Secondary Outcome Measures
Inflammatory Marker Levels
Inflammatory marker serum concentration quantification (free IgE, total IgE, interleukin 6, tumor necrosis factor alpha, tryptase).
Structural MRI
The software Freesurfer will be used to calculate volume of brain regions and diffusion parameters (e.g. fractional anisotropy and mean diffusivity) from structural T1 and diffusion tensor images respectively. Paired t-test will be used to compare brain volume at baseline and post-treatment.
Functional MRI (resting state)
Correlation analysis will be used to calculate the connectivity across different brain regions. Paired t-test will be used to compare differences in activity at baseline and post-treatment.
Generalized Anxiety Disorder 7-item (GAD-7)
Anxiety symptom questionnaire - Scoring is based on how frequently the subject experienced 7 GAD-related symptoms in the last two weeks. Each question is rated on a 0-3 scale: 0 - "Not at all", 1 - "Several days", 2 - "More than half the days", 3 - "Nearly every day." Defined cutoffs will be used to define severity.
Epworth Sleepiness Scale (ESS)
Sleepiness Questionnaire - Scoring is based on how likely the subject is to doze off or fall asleep during 8 daily activities. Higher scores indicate more severe sleepiness.
Pittsburgh Sleep Quality Index (PSQI)
Sleep Quality Questionnaire - Scoring is based on 19 self-administered questions and 5 roommate questions. An algorithm provided with the questionnaire will be used to calculate global sleep quality score, for which a higher score indicates greater severity.
Asthma Control Test (ACT)
A 5 question patient survey designed to identify patients with poorly controlled asthma based on the symptom severity over the last 4 weeks.
Rhinitis Control Assessment Test (RCAT)
A 6 question patient survey designed to evaluate rhinitis symptom control based on symptom severity and frequency over the past week.
Validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD)
A clinical assessment tool used to describe severity of atopic dermatitis. The vIGA-AD includes a single scale from 0-4, in which 0 is "clear" and 4 is "severe."
Full Information
NCT ID
NCT04535817
First Posted
August 13, 2020
Last Updated
August 11, 2021
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT04535817
Brief Title
Xolair Interventional Study in ASD Patients With Comorbid Atopy
Official Title
The Effect of Omalizumab (Xolair) on Improving Neuropsychiatric Symptoms in a Subset of ASD Patients With Atopic Disease and Elevated Total IgE Levels
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
We are terminating due to loss of funding because of Covid-19.
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Novartis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Atopy
Keywords
omalizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Baseline testing, followed by 24-week treatment period, followed by 24-week follow-up period.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Subjects will receive subcutaneous treatment of 300mg of omalizumab during the 24-week treatment period. One injection will be administered every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Omalizumab Injection [Xolair]
Other Intervention Name(s)
Xolair
Intervention Description
300mg via 2 subcutaneous injections every 4 weeks
Primary Outcome Measure Information:
Title
Change from Baseline to Week 12 in Social Responsiveness Scale (SRS) Edition 2
Description
Social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Time Frame
Baseline and Week 12
Title
Change from Baseline to Week 24 in Social Responsiveness Scale (SRS) Edition 2
Description
Social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Time Frame
Baseline and Week 24
Title
Change from Baseline to Week 48 in Social Responsiveness Scale (SRS) Edition 2
Description
Social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Time Frame
Baseline and Week 48
Title
Change from Week 24 to Week 48 in Social Responsiveness Scale (SRS) Edition 2
Description
Social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Time Frame
Week 24 (conclusion of treatment period) and Week 48 (follow-up)
Title
Change from Baseline to Week 12 in Aberrant Behavior Checklist (ABC)
Description
Social behavior test - The total score is calculated based on 5 sub-scales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). There are 58 questions that are scored on a 0-3 scale 0 -"not at all a problem", 1- "the behavior is a problem but slight in degree", 2- "the problem is moderately serious" and 3- "the problem is severe in degree". Based on this sub-scores are calculated and added to get the total score.
Time Frame
Baseline and Week 12
Title
Change from Baseline to Week 24 in Aberrant Behavior Checklist (ABC)
Description
Social behavior test - The total score is calculated based on 5 sub-scales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). There are 58 questions that are scored on a 0-3 scale 0 -"not at all a problem", 1- "the behavior is a problem but slight in degree", 2- "the problem is moderately serious" and 3- "the problem is severe in degree". Based on this sub-scores are calculated and added to get the total score.
Time Frame
Baseline and Week 24 (conclusion of treatment period)
Title
Change from Baseline to Week 48 in Aberrant Behavior Checklist (ABC)
Description
Social behavior test - The total score is calculated based on 5 sub-scales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). There are 58 questions that are scored on a 0-3 scale 0 -"not at all a problem", 1- "the behavior is a problem but slight in degree", 2- "the problem is moderately serious" and 3- "the problem is severe in degree". Based on this sub-scores are calculated and added to get the total score.
Time Frame
Baseline and Week 48 (follow-up)
Title
Change from Week 24 to Week 48 in Aberrant Behavior Checklist (ABC)
Description
Social behavior test - The total score is calculated based on 5 sub-scales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). There are 58 questions that are scored on a 0-3 scale 0 -"not at all a problem", 1- "the behavior is a problem but slight in degree", 2- "the problem is moderately serious" and 3- "the problem is severe in degree". Based on this sub-scores are calculated and added to get the total score.
Time Frame
Week 24 (conclusion of treatment period) and Week 48 (follow-up)
Title
Change from Baseline to Week 1 in Autism Treatment Evaluation Checklist (ATEC)
Description
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Time Frame
Baseline and Week 1
Title
Change from Baseline to Week 4 in Autism Treatment Evaluation Checklist (ATEC)
Description
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Time Frame
Baseline and Week 4
Title
Change from Baseline to Week 8 in Autism Treatment Evaluation Checklist (ATEC)
Description
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Time Frame
Baseline and Week 8
Title
Change from Baseline to Week 12 in Autism Treatment Evaluation Checklist (ATEC)
Description
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Time Frame
Baseline and Week 12
Title
Change from Baseline to Week 16 in Autism Treatment Evaluation Checklist (ATEC)
Description
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Time Frame
Baseline and Week 16
Title
Change from Baseline to Week 20 in Autism Treatment Evaluation Checklist (ATEC)
Description
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Time Frame
Baseline and Week 20
Title
Change from Baseline to Week 24 in Autism Treatment Evaluation Checklist (ATEC)
Description
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Time Frame
Baseline and Week 24 (conclusion of treatment period)
Title
Change from Baseline to Week 48 in Autism Treatment Evaluation Checklist (ATEC)
Description
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Time Frame
Baseline and Week 48 (follow-up)
Title
Change from Week 24 to Week 48 in Autism Treatment Evaluation Checklist (ATEC)
Description
Social Behavior Test - The total score is calculated by adding together the scores of 4 subtests (Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). This 67 question test will provide scores for each subtest and a total score, for which a higher score indicates greater symptom severity.
Time Frame
Week 24 (conclusion of treatment period) and Week 48 (follow-up)
Secondary Outcome Measure Information:
Title
Inflammatory Marker Levels
Description
Inflammatory marker serum concentration quantification (free IgE, total IgE, interleukin 6, tumor necrosis factor alpha, tryptase).
Time Frame
Baseline, Week 12, and Week 24 (conclusion of treatment period)
Title
Structural MRI
Description
The software Freesurfer will be used to calculate volume of brain regions and diffusion parameters (e.g. fractional anisotropy and mean diffusivity) from structural T1 and diffusion tensor images respectively. Paired t-test will be used to compare brain volume at baseline and post-treatment.
Time Frame
Baseline and Week 24 (conclusion of treatment period)
Title
Functional MRI (resting state)
Description
Correlation analysis will be used to calculate the connectivity across different brain regions. Paired t-test will be used to compare differences in activity at baseline and post-treatment.
Time Frame
Baseline, and Week 24 (conclusion of treatment period)
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
Anxiety symptom questionnaire - Scoring is based on how frequently the subject experienced 7 GAD-related symptoms in the last two weeks. Each question is rated on a 0-3 scale: 0 - "Not at all", 1 - "Several days", 2 - "More than half the days", 3 - "Nearly every day." Defined cutoffs will be used to define severity.
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Epworth Sleepiness Scale (ESS)
Description
Sleepiness Questionnaire - Scoring is based on how likely the subject is to doze off or fall asleep during 8 daily activities. Higher scores indicate more severe sleepiness.
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep Quality Questionnaire - Scoring is based on 19 self-administered questions and 5 roommate questions. An algorithm provided with the questionnaire will be used to calculate global sleep quality score, for which a higher score indicates greater severity.
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Asthma Control Test (ACT)
Description
A 5 question patient survey designed to identify patients with poorly controlled asthma based on the symptom severity over the last 4 weeks.
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Rhinitis Control Assessment Test (RCAT)
Description
A 6 question patient survey designed to evaluate rhinitis symptom control based on symptom severity and frequency over the past week.
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD)
Description
A clinical assessment tool used to describe severity of atopic dermatitis. The vIGA-AD includes a single scale from 0-4, in which 0 is "clear" and 4 is "severe."
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Other Pre-specified Outcome Measures:
Title
Clinical Global Impressions Scale - Improvement (CGI-I)
Description
Psychological Clinical Assessment - Conducted by a physician, this 7-point scale characterizes changes in the subject's clinical presentation.
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Clinical Global Impressions Scale - Severity (CGI-S)
Description
Psychological Clinical Assessment - Conducted by a physician, this 7-point scale defines severity of the subject's psychopathology.
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Autonomic indices 1
Description
Blood volume pulse
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Autonomic indices 2
Description
Heart Rate
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Autonomic indices 3
Description
Blood oxygen saturation
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Autonomic indices 4
Description
Carboxyhemoglobin blood saturation
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Title
Autonomic indices 5
Description
Blood pressure
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xue-Jun Kong, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share data with researchers not directly involved in this study and on the research team.
Learn more about this trial
Xolair Interventional Study in ASD Patients With Comorbid Atopy
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