Autism Spectrum DisorderPhase 1NCT04535817
Xolair Interventional Study in ASD Patients With Comorbid Atopy
A Phase 1 study testing Omalizumab Injection [Xolair] in people with Autism Spectrum Disorder and Atopy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder, Atopy
- What is being tested?
- Omalizumab Injection [Xolair]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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
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.
Read the 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
- Being tested
- Omalizumab Injection [Xolair]
- Keywords
- omalizumab
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omalizumab Injection [Xolair]Drug
Also called Xolair
300mg via 2 subcutaneous injections every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects will receive subcutaneous treatment of 300mg of omalizumab during the 24-week treatment period. One injection will be administered every 4 weeks. Receives: Drug: Omalizumab Injection [Xolair] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and Week 12
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).
Measured: Baseline and Week 24
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).
Measured: Baseline and Week 48
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).
Measured: Week 24 (conclusion of treatment period) and Week 48 (follow-up)
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 24 (conclusion of treatment period)
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.
Measured: Baseline and Week 48 (follow-up)
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.
Measured: Week 24 (conclusion of treatment period) and Week 48 (follow-up)
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.
Measured: Baseline and Week 1
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 16
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.
Measured: Baseline and Week 20
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.
Measured: Baseline and Week 24 (conclusion of treatment period)
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.
Measured: Baseline and Week 48 (follow-up)
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.
Measured: Week 24 (conclusion of treatment period) and Week 48 (follow-up)
Secondary outcomes (9)
Inflammatory Marker Levels
Inflammatory marker serum concentration quantification (free IgE, total IgE, interleukin 6, tumor necrosis factor alpha, tryptase).
Measured: Baseline, Week 12, and Week 24 (conclusion of treatment period)
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.
Measured: Baseline and Week 24 (conclusion of treatment period)
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.
Measured: Baseline, and Week 24 (conclusion of treatment period)
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.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
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.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
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.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
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.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
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.
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
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."
Measured: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (conclusion of treatment period), and Week 48 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Why it stopped: We are terminating due to loss of funding because of Covid-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Baseline testing, followed by 24-week treatment period, followed by 24-week follow-up period.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Xue-Jun Kong, Beth Israel Deaconess Medical Center
- Investigators
- Xue-Jun Kong, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535817
- Sponsor's protocol ID
- 2020P000753
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data with researchers not directly involved in this study and on the research team.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04535817
- Acronym / sponsor ID
- 2020P000753
- Conditions
- Autism Spectrum Disorder, Atopy
- Keywords
- omalizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We are terminating due to loss of funding because of Covid-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Baseline testing, followed by 24-week treatment period, followed by 24-week follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Omalizumab Injection [Xolair]Subjects will receive subcutaneous treatment of 300mg of omalizumab during the 24-week treatment period. One injection will be administered every 4 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omalizumab Injection [Xolair]Also: Xolair300mg via 2 subcutaneous injections every 4 weeks | Drug | Treatment Group |
Primary outcome
Change from Baseline to Week 12 in Social Responsiveness Scale (SRS) Edition 2
Time frame: Baseline and Week 12
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
Time frame: Baseline and Week 24
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
Time frame: Baseline and Week 48
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
Time frame: Week 24 (conclusion of treatment period) and Week 48 (follow-up)
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)
Time frame: Baseline and Week 12
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)
Time frame: Baseline and Week 24 (conclusion of treatment period)
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)
Time frame: Baseline and Week 48 (follow-up)
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)
Time frame: Week 24 (conclusion of treatment period) and Week 48 (follow-up)
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)
Time frame: Baseline and Week 1
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)
Time frame: Baseline and Week 4
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)
Time frame: Baseline and Week 8
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)
Time frame: Baseline and Week 12
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)
Time frame: Baseline and Week 16
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)
Time frame: Baseline and Week 20
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)
Time frame: Baseline and Week 24 (conclusion of treatment period)
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)
Time frame: Baseline and Week 48 (follow-up)
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)
Time frame: Week 24 (conclusion of treatment period) and Week 48 (follow-up)
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.
9 secondary outcomes
Inflammatory Marker Levels
Time frame: Baseline, Week 12, and Week 24 (conclusion of treatment period)
Structural MRI
Time frame: Baseline and Week 24 (conclusion of treatment period)
Functional MRI (resting state)
Time frame: Baseline, and Week 24 (conclusion of treatment period)
Generalized Anxiety Disorder 7-item (GAD-7)
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)
Epworth Sleepiness Scale (ESS)
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)
Pittsburgh Sleep Quality Index (PSQI)
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)
Asthma Control Test (ACT)
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)
Rhinitis Control Assessment Test (RCAT)
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)
Validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No. There is no plan to share data with researchers not directly involved in this study and on the research team.
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Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xue-Jun Kong, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omalizumab Injection [Xolair] in people with Autism Spectrum Disorder and Atopy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 12 in Social Responsiveness Scale (SRS) Edition 2 (time frame: Baseline and Week 12). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.