Eosinophilic DisorderEarly Phase 1STRINGNCT04943744
Gastrointestinal STRING Test With Oral Immunotherapy
A Early Phase 1 study testing Entero-tracker, omalizumab and dupliumab in people with Eosinophilic Disorder and Food Allergy, run by Stanford University at 1 site in United States.
Trial summary
This STRING study will examine markers of esophageal inflammation using a minimally-invasive testing device, the esophageal string test (EST). The primary objective is to determine the effect of omalizumab (Xolair) and dupilumab (Dupixent) on markers of eosinophilic inflammation in the esophagus of subjects treated… Read more about this study
- Who is it for?
- Ages 5 to 55 years
- Conditions the study is for
- Eosinophilic Disorder, Food Allergy
- What is being tested?
- Entero-tracker, omalizumab and dupliumab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 17 May 2024
- Phase
- Early 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 5 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria: • Participants, aged 5-55 years enrolled in the parent COMBINE trial
- Able to swallow the EST.
Exclusion Criteria: • Allergy to, or inability to ingest, gelatin
-
Trial locations and contacts
1 site in 1 country.
United States1 site
Sean N Parker Center for Allergy and Asthma Research at Stanford University
Palo Alto, California, 94304
About this study
Official title: Monitoring Gastrointestinal Responses In Food Oral Immunotherapy Using the Esophageal STRING Test
This STRING study will examine markers of esophageal inflammation using a minimally-invasive testing device, the esophageal string test (EST). The primary objective is to determine the effect of omalizumab (Xolair) and dupilumab (Dupixent) on markers of eosinophilic inflammation in the esophagus of subjects treated with omalizumab-facilitated mOIT(mult-allergen oral immunotherapy) and/or mOIT with concurrent dupilumab.
Read the detailed description
This is a companion study to a phase 2 randomized, controlled, double-blind clinical trial using biologics to improve multi-allergen oral immunotherapy (mOIT) outcomes. The parent study (COMBINE NCT03679676) consists of a screening period, 8 weeks of omalizumab or placebo injections, and 24 weeks of OIT with dupilumab or placebo injections followed by an off-treatment period.
This STRING companion study will examine markers of esophageal inflammation during the COMBINE study using a minimally-invasive testing device, the esophageal string test (EST). If participants of COMBINE consent to this companion study, they will undergo an esophageal string test at the following time points in COMBINE:
- During screening, prior to week 0, which will be baseline for the STRING esophageal test
- Week 8, After the 8 weeks of treatment with omalizumab/placebo
- If dose-related gastrointestinal (GI) side effects occur during the week 10-32 treatment period (OIT and dupilumab/placebo)
- At Week 32, after 24 weeks of treatment with OIT and dupilumab or placebo
- Conditions
- Eosinophilic Disorder, Food Allergy
- Being tested
- Entero-tracker, omalizumab, dupliumab
- Medical subject headings
- Eosinophilia, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entero-trackerDevice
Esophageal STRING test (Entero-tracker)
omalizumabBiological
Used in the parent study
dupliumabBiological
Used in the parent study
| Study group | Role | What they receive |
|---|---|---|
| String Test-cohort A | Other | Participants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms.
A. Omalizumab for 8 weeks followed by mOIT with placebo for dupilumab for 24 weeks (Cohort A: Omalizumab-facilitated mOIT) Receives: Device: Entero-tracker; Biological: omalizumab |
| String Test-cohort B | Other | Participants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms.
B. Omalizumab for 8 weeks followed by mOIT with dupilumab for 24 weeks (Cohort B: Omalizumab-facilitated mOIT with concurrent dupilumab) Receives: Device: Entero-tracker; Biological: omalizumab; Biological: dupliumab |
| String Test-cohort C | Other | Participants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms.
C. Placebo for omalizumab for 8 weeks followed by mOIT with dupilumab for 24 weeks (Cohort C: mOIT with concurrent dupilumab) Receives: Device: Entero-tracker; Biological: dupliumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of subjects with esophageal eosinophilia (EE)
(defined as an EST score ≥ 2.9) in subjects receiving omalizumab-facilitated mOIT and/or mOIT with concurrent
Measured: 32 weeks
Secondary outcomes (1)
Comparison of EST scores
Comparison of EST scores (composite measure of eosinophilic inflammation) before and after treatment with omalizumab
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start17 May 2021
- Primary completion17 May 2024
- Study completion17 May 2024
Why it stopped: Parent study closed to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic DisorderStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This STRING companion study will examine markers of esophageal inflammation during the COMBINE study using a minimally-invasive testing device, the esophageal string test (EST). If participants of COMBINE consent to this companion study, they will undergo an esophageal string test at the following time points in COMBINE: * During screening, prior to week 0, which will be baseline for the STRING esophageal test * Week 8, After the 8 weeks of treatment with omalizumab/placebo * If dose-related gastrointestinal (GI) side effects occur during the week 10-32 treatment period (OIT and dupilumab/placebo) * At Week 32, after 24 weeks of treatment with OIT and dupilumab or placebo
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Sharon Chinthrajah, Stanford University
- Investigators
- Sharon Chinthrajah, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943744
- Sponsor's protocol ID
- 58997
- Acronym
- STRING
- Status last verified
- Sep 2024
- First submitted
- 21 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Gastrointestinal Responses In Food Oral Immunotherapy Using the Esophageal STRING Test
- ClinicalTrials.gov ID
- NCT04943744
- Acronym / sponsor ID
- STRING / 58997
- Conditions
- Eosinophilic Disorder, Food Allergy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Parent study closed to enrollment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 29 Jun 2021 (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.
This STRING study will examine markers of esophageal inflammation using a minimally-invasive testing device, the esophageal string test (EST). The primary objective is to determine the effect of omalizumab (Xolair) and dupilumab (Dupixent) on markers of eosinophilic inflammation in the esophagus of subjects treated with omalizumab-facilitated mOIT(mult-allergen oral immunotherapy) and/or mOIT with concurrent dupilumab.
Detailed description
This is a companion study to a phase 2 randomized, controlled, double-blind clinical trial using biologics to improve multi-allergen oral immunotherapy (mOIT) outcomes. The parent study (COMBINE NCT03679676) consists of a screening period, 8 weeks of omalizumab or placebo injections, and 24 weeks of OIT with dupilumab or placebo injections followed by an off-treatment period.
This STRING companion study will examine markers of esophageal inflammation during the COMBINE study using a minimally-invasive testing device, the esophageal string test (EST). If participants of COMBINE consent to this companion study, they will undergo an esophageal string test at the following time points in COMBINE:
- During screening, prior to week 0, which will be baseline for the STRING esophageal test
- Week 8, After the 8 weeks of treatment with omalizumab/placebo
- If dose-related gastrointestinal (GI) side effects occur during the week 10-32 treatment period (OIT and dupilumab/placebo)
- At Week 32, after 24 weeks of treatment with OIT and dupilumab or placebo
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This STRING companion study will examine markers of esophageal inflammation during the COMBINE study using a minimally-invasive testing device, the esophageal string test (EST). If participants of COMBINE consent to this companion study, they will undergo an esophageal string test at the following time points in COMBINE: * During screening, prior to week 0, which will be baseline for the STRING esophageal test * Week 8, After the 8 weeks of treatment with omalizumab/placebo * If dose-related gastrointestinal (GI) side effects occur during the week 10-32 treatment period (OIT and dupilumab/placebo) * At Week 32, after 24 weeks of treatment with OIT and dupilumab or placebo
| Arm | Type | Receives |
|---|---|---|
| String Test-cohort A | Other | Device: Entero-tracker, Biological: omalizumabParticipants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms. A. Omalizumab for 8 weeks followed by mOIT with placebo for dupilumab for 24 weeks (Cohort A: Omalizumab-facilitated mOIT) |
| String Test-cohort B | Other | Device: Entero-tracker, Biological: omalizumab, Biological: dupliumabParticipants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms. B. Omalizumab for 8 weeks followed by mOIT with dupilumab for 24 weeks (Cohort B: Omalizumab-facilitated mOIT with concurrent dupilumab) |
| String Test-cohort C | Other | Device: Entero-tracker, Biological: dupliumabParticipants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms. C. Placebo for omalizumab for 8 weeks followed by mOIT with dupilumab for 24 weeks (Cohort C: mOIT with concurrent dupilumab) |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Entero-trackerEsophageal STRING test (Entero-tracker) | Device | String Test-cohort A, String Test-cohort B, String Test-cohort C |
| omalizumabUsed in the parent study | Biological | String Test-cohort A, String Test-cohort B |
| dupliumabUsed in the parent study | Biological | String Test-cohort B, String Test-cohort C |
Primary outcome
Comparison of the proportion of subjects with esophageal eosinophilia (EE)
Time frame: 32 weeks
(defined as an EST score ≥ 2.9) in subjects receiving omalizumab-facilitated mOIT and/or mOIT with concurrent
1 secondary outcome
Comparison of EST scores
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Parent study closed to enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Sharon Chinthrajah, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Entero-tracker, omalizumab and dupliumab in people with Eosinophilic Disorder and Food Allergy, run by Stanford 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?
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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 stopped early (reason given: Parent study closed to enrollment). Results are not available in the source record.
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?
Comparison of the proportion of subjects with esophageal eosinophilia (EE) (time frame: 32 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 19 Sep 2024.