Allergic AsthmaPhase 4NCT02023151
Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils
A Phase 4 study testing Omalizumab in people with Allergic Asthma, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to test whether differences in blood cells at baseline (start of the study) can be used to predict how well omalizumab will work in a patient. Omalizumab (Xolair) is a drug approved by the U.S. Food and Drug Administration (FDA) to treat asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate-to-severe asthma; male and females aged 18-75 who are symptomatic despite treatment with inhaled corticosteroids if they also had an asthma duration > 1 year.
- Positive blood testing to at least one common allergen (including must mite, D. F. and D. P., cockroach, dog or cat)
- Serum IgE within the bounds of the dosing table (>30 IU/ml to < 700 IU/ml)
- Reversibility of > 12% within 30 minutes after administration of albuterol or history of reversibility in past or history of positive methacholine in past
- Baseline Forced expiratory volume (FEV1) of > 0% and < 80% of predicted
- Treatment with 400 to 800 ug day of beclomethasone dipropionate or its equivalent.
- Patients must be willing to give written informed consent and be able to adhere to dose and visit schedules and meet trial requirements.
- Patients will be excluded if they have prior sensitivity to omalizumab, and acute respiratory tract infection prior to or during the run-in period, or a need for regular B-agonist use.
Who cannot join
- Treatment with an investigational agent within 30 days of screening
- Previously treated with omalizumab within a year prior to screening
- Treatment 1 month prior to screening with: hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G, and plasmapheresis
- Clinically relevant laboratory anomalies at screening including individuals with reduced hematocrit (<32%), White Blood Cell (WBC) count (2400/microliter), platelet count (< 75000/microliter), and increased creatinine (> 141.4 micromolar/L), or aminotransferase (AST) (>100 IU/L).
- Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy, or bleeding disorder.
- History of any medical condition that is unstable
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- Inability to comply with study and follow-up procedures
- Patients may not take systemic corticosteroids within 2 weeks prior to screening\
- Women of childbearing potential who are pregnant or nursing mothers, or who are of childbearing potential (post-menarche) and are not practicing an acceptable form of contraception ( as determined by the site investigator)
- Individuals with body weight less than 30 kg or greater than 150 kg.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Asthma & Allergy Center
Baltimore, Maryland, 21212
About this study
Official title: Predicting the Clinical Response to Omalizumab With Anti-IgE Response or Syk Expression in Basophils
This research is being done to test whether differences in blood cells at baseline (start of the study) can be used to predict how well omalizumab will work in a patient. Omalizumab (Xolair) is a drug approved by the U.S. Food and Drug Administration (FDA) to treat asthma. Studies show that omalizumab improves the symptoms of asthma but some people experience better improvement than others.
Read the detailed description
From a therapeutic perspective, the study will determine whether changes in the peripheral blood basophil response to crosslinking anti-IgE Ab during treatment with omalizumab predicts the clinical efficacy of treatment with the drug. Secondary outcomes measures would focus on whether the starting level of anti-IgE-mediated histamine release, or the changes syk expression or its starting level would be sufficient to predict the clinical outcome.
The study is a single-site trial to evaluate the utility of baseline basophil measures to predict the efficacy of subcutaneously administered omalizumab as an add-on therapy for the treatment of adult patients 18-75 years old who have been diagnosed with moderate to severe asthma according to current approved guidelines. Patients will be treated with omalizumab according to the standard FDA approved dosing table for a period of 16 weeks.
- Conditions
- Allergic Asthma
- Being tested
- Omalizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called xolair
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Other | Active Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab
Data will be analyzed for the fold change in the in vitro anti-IgE-mediated histamine release response
Measured: baseline and 26 weeks
Secondary outcomes (1)
Changes in Syk Expression
Change in syk expression. Syk is a signaling molecule that is the first downstream event in IgE receptor activation of basophils.
Measured: baseline and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Sarbjit S. Saini, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023151
- Sponsor's protocol ID
- NA_00081287
- Status last verified
- Nov 2017
- First submitted
- 17 Dec 2013
- Last updated
- 11 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Clinical Response to Omalizumab With Anti-IgE Response or Syk Expression in Basophils
- ClinicalTrials.gov ID
- NCT02023151
- Acronym / sponsor ID
- NA_00081287
- Conditions
- Allergic Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Posted 11 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to test whether differences in blood cells at baseline (start of the study) can be used to predict how well omalizumab will work in a patient. Omalizumab (Xolair) is a drug approved by the U.S. Food and Drug Administration (FDA) to treat asthma. Studies show that omalizumab improves the symptoms of asthma but some people experience better improvement than others.
Detailed description
From a therapeutic perspective, the study will determine whether changes in the peripheral blood basophil response to crosslinking anti-IgE Ab during treatment with omalizumab predicts the clinical efficacy of treatment with the drug. Secondary outcomes measures would focus on whether the starting level of anti-IgE-mediated histamine release, or the changes syk expression or its starting level would be sufficient to predict the clinical outcome.
The study is a single-site trial to evaluate the utility of baseline basophil measures to predict the efficacy of subcutaneously administered omalizumab as an add-on therapy for the treatment of adult patients 18-75 years old who have been diagnosed with moderate to severe asthma according to current approved guidelines. Patients will be treated with omalizumab according to the standard FDA approved dosing table for a period of 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Other | Drug: OmalizumabActive |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with moderate-to-severe asthma; male and females aged 18-75 who are symptomatic despite treatment with inhaled corticosteroids if they also had an asthma duration > 1 year.
- Positive blood testing to at least one common allergen (including must mite, D. F. and D. P., cockroach, dog or cat)
- Serum IgE within the bounds of the dosing table (>30 IU/ml to < 700 IU/ml)
- Reversibility of > 12% within 30 minutes after administration of albuterol or history of reversibility in past or history of positive methacholine in past
- Baseline Forced expiratory volume (FEV1) of > 0% and < 80% of predicted
Key exclusion criteria (10 listed)
- Treatment with an investigational agent within 30 days of screening
- Previously treated with omalizumab within a year prior to screening
- Treatment 1 month prior to screening with: hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G, and plasmapheresis
- Clinically relevant laboratory anomalies at screening including individuals with reduced hematocrit (<32%), White Blood Cell (WBC) count (2400/microliter), platelet count (< 75000/microliter), and increased creatinine (> 141.4 micromolar/L), or aminotransferase (AST) (>100 IU/L).
- Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy, or bleeding 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 |
|---|---|---|
| OmalizumabAlso: xolair | Drug | Omalizumab |
Primary outcome
Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab
Time frame: baseline and 26 weeks
Data will be analyzed for the fold change in the in vitro anti-IgE-mediated histamine release response
1 secondary outcome
Changes in Syk Expression
Time frame: baseline and 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sarbjit S. Saini, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omalizumab in people with Allergic Asthma, run by Johns Hopkins University 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 11 Dec 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab (time frame: baseline and 26 weeks). 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 11 Dec 2017.