Eosinophilic EsophagitisPhase 1NCT01040598
Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
A Phase 1 study testing Omalizumab in people with Eosinophilic Esophagitis, run by O & O Alpan LLC at 1 site in United States.
Trial summary
Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea, epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal symptoms along with obstructive esophageal symptoms in both pediatric and adult population. Read more about this study
- Who is it for?
- Ages 12 to 76 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2011
- 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 12 to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Established diagnosis of eosinophilic esophagitis, determined by eosinophils >15/high power field in the distal esophagus and/or microabscesses.
- Patients should be on therapy either by food avoidance or swallowed steroids, with no change in the food avoidance and steroid dose during therapy.
- One active symptom of disease (epigastric pain, vomiting, nausea, dysphagia or heartburn) at least 2 days of the week.
- Failed response to proton pump inhibitors or a negative ph probe test or Negative impedance study.
- Males and females between ages 12-76 years.
Who cannot join
- Patients with gastrointestinal reflux disease.
- Eosinophilic disease in the stomach or duodenum.
- Peripheral eosinophil counts >1500 (hyper eosinophilic syndrome).
- Women of childbearing potential not using two forms of contraception method(s) including but not limited to condoms, diaphragm, oral contraceptive pills, other hormonal methods, intrauterine device or tubal ligation and vasectomy, as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s).
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required).
Show all 14Show fewer
- Use of any other investigational agent in the last 30 days.
- Use of systemic or inhaled steroids within the past 1 month.
- History of malignancy.
- Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc.
- Have been treated with Xolair within the 12 months prior to screening.
- Patients with eosinophilic esophagitis in remission on swallowed steroids.
- Patients with asthma taking inhaled steroids.
- Serum IgE levels < 30 IU/l or > 700 IU/l
Trial locations and contacts
1 site in 1 country.
About this study
Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea, epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal symptoms along with obstructive esophageal symptoms in both pediatric and adult population. The pathology of this disease is postulated to be allergy mediated and the incidence of this disease is seen to parallel an increase in the incidence of allergies and asthma.
Most of the current therapies for EoE are directed at decreasing esophageal allergic inflammation and mirror the treatment options for allergic asthma. Swallowed corticosteroids and elimination diets or elemental diets have shown variable efficacy is improving symptoms. However, specific pathophysiologic mechanism of EoE is still largely unknown and there is no definitive treatment that completely resolves symptoms and histological findings. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids and improve asthma related symptoms in patients with allergic asthma. In this study, Eosinophilic esophagitis is being used as a disease model to study the mechanism of action of monoclonal Anti-IgE antibody in vivo. The resolution of symptoms clinically, and histological changes (and improvements) in response to treatment with Xolair (omalizumab) in patients suffering from EoE will be determined. The primary objective of this open label, study is to determine mucosal markers that will predict responders to Omalizumab (Xolair).
Read the detailed description
This is an open label mechanistic study to learn about the effect of Omalizumab on the clinical symptoms and immunohistological findings in established cases of EoE. The dosage for Omalizumab will be based on patient's body weight and baseline IgE level. Omalizumab will be administered subcutaneously every 2 or 4 weeks for total duration of 12 weeks. At enrollment, subjects will have EGD with biopsies performed to confirm diagnosis of EoE and further histologic analysis and special staining. Blood will be drawn for baseline testing and monthly for safety labs. At the end of the 12 week period, repeat endoscopy will be performed and biopsies taken to stain again for various mucosal markers like IgE, IL-13, IL-5 and Tryptase. The patients will be followed for response to therapy with regards to resolution of symptoms and improvement in histology findings on biopsy.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Omalizumab
- Keywords
- Eosinophilic Esophagitis, Xolair, Omalizumab, Esophagitis, Eosinophils, monoclonal antibody
- Medical subject headings
- Eosinophilic Esophagitis, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabBiological
Also called Xolair
Omalizumab, an anti-IgE monoclonal antibody is dosed on the basis of subject's weight and IgE levels. It is administered as a subcutaneous injection every 2 weeks or 4 weeks based on the total dose required.
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary objective is to determine markers that will predict responders to Omalizumab(Xolair)
Measured: 12 weeks
Secondary outcomes (1)
Secondary objectives will be determining the immunological changes in the tissue before and after treatment with Xolair (omalizumab)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- O & O Alpan LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Oral Alpan, MD, Principal investigator, O & O Alpan LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040598
- Sponsor's protocol ID
- EE001
- Status last verified
- Mar 2012
- First submitted
- 27 Dec 2009
- Last updated
- 14 Mar 2012
- Results posted
- No
Publications
Loizou D, Enav B, Komlodi-Pasztor E, Hider P, Kim-Chang J, Noonan L, Taber T, Kaushal S, Limgala R, Brown M, Gupta R, Balba N, Goker-Alpan O, Khojah A, Alpan O. A pilot study of omalizumab in eosinophilic esophagitis. PLoS One. 2015 Mar 19;10(3):e0113483. doi: 10.1371/journal.pone.0113483. eCollection 2015.
PubMed 25789989
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
- ClinicalTrials.gov ID
- NCT01040598
- Acronym / sponsor ID
- EE001
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis, Xolair, Omalizumab, Esophagitis, Eosinophils, monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- O & O Alpan LLCUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- First posted
- 29 Dec 2009 (estimated)
- 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.
Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea, epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal symptoms along with obstructive esophageal symptoms in both pediatric and adult population. The pathology of this disease is postulated to be allergy mediated and the incidence of this disease is seen to parallel an increase in the incidence of allergies and asthma.
Most of the current therapies for EoE are directed at decreasing esophageal allergic inflammation and mirror the treatment options for allergic asthma. Swallowed corticosteroids and elimination diets or elemental diets have shown variable efficacy is improving symptoms. However, specific pathophysiologic mechanism of EoE is still largely unknown and there is no definitive treatment that completely resolves symptoms and histological findings. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids and improve asthma related symptoms in patients with allergic asthma. In this study, Eosinophilic esophagitis is being used as a disease model to study the mechanism of action of monoclonal Anti-IgE antibody in vivo. The resolution of symptoms clinically, and histological changes (and improvements) in response to treatment with Xolair (omalizumab) in patients suffering from EoE will be determined. The primary objective of this open label, study is to determine mucosal markers that will predict responders to Omalizumab (Xolair).
Detailed description
This is an open label mechanistic study to learn about the effect of Omalizumab on the clinical symptoms and immunohistological findings in established cases of EoE. The dosage for Omalizumab will be based on patient's body weight and baseline IgE level. Omalizumab will be administered subcutaneously every 2 or 4 weeks for total duration of 12 weeks. At enrollment, subjects will have EGD with biopsies performed to confirm diagnosis of EoE and further histologic analysis and special staining. Blood will be drawn for baseline testing and monthly for safety labs. At the end of the 12 week period, repeat endoscopy will be performed and biopsies taken to stain again for various mucosal markers like IgE, IL-13, IL-5 and Tryptase. The patients will be followed for response to therapy with regards to resolution of symptoms and improvement in histology findings on biopsy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Established diagnosis of eosinophilic esophagitis, determined by eosinophils >15/high power field in the distal esophagus and/or microabscesses.
- Patients should be on therapy either by food avoidance or swallowed steroids, with no change in the food avoidance and steroid dose during therapy.
- One active symptom of disease (epigastric pain, vomiting, nausea, dysphagia or heartburn) at least 2 days of the week.
- Failed response to proton pump inhibitors or a negative ph probe test or Negative impedance study.
- Males and females between ages 12-76 years.
Key exclusion criteria (14 listed)
- Patients with gastrointestinal reflux disease.
- Eosinophilic disease in the stomach or duodenum.
- Peripheral eosinophil counts >1500 (hyper eosinophilic syndrome).
- Women of childbearing potential not using two forms of contraception method(s) including but not limited to condoms, diaphragm, oral contraceptive pills, other hormonal methods, intrauterine device or tubal ligation and vasectomy, as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s).
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: XolairOmalizumab, an anti-IgE monoclonal antibody is dosed on the basis of subject's weight and IgE levels. It is administered as a subcutaneous injection every 2 weeks or 4 weeks based on the total dose required. | Biological | – |
Primary outcome
Our primary objective is to determine markers that will predict responders to Omalizumab(Xolair)
Time frame: 12 weeks
1 secondary outcome
Secondary objectives will be determining the immunological changes in the tissue before and after treatment with Xolair (omalizumab)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
- Derived from this study: PubMed 25789989Loizou D, Enav B, Komlodi-Pasztor E, Hider P, Kim-Chang J, Noonan L, Taber T, Kaushal S, Limgala R, Brown M, Gupta R, Balba N, Goker-Alpan O, Khojah A, Alpan O. A pilot study of omalizumab in eosinophilic esophagitis. PLoS One. 2015 Mar 19;10(3):e0113483. doi: 10.1371/journal.pone.0113483. eCollection 2015.
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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.
Oral Alpan, MD principal investigator
O & O Alpan LLC
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 in people with Eosinophilic Esophagitis, run by O & O Alpan LLC 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 5 inclusion and 14 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 14 Mar 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Our primary objective is to determine markers that will predict responders to Omalizumab(Xolair) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01040598, which also lists 1 linked publication.
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 14 Mar 2012.