Peanut AllergyPhase 2FASTXNCT02402231
Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy
A Phase 2 study testing Omalizumab in people with Peanut Allergy, run by Caroline Nilsson at 1 site in Sweden.
Trial summary
Severe peanut allergy is different from other allergic reactions because it can lead to fatal reactions and is an invisible disability. There is no cure today. The purpose of this study is to treat children and adolescents with severe peanut allergy with oral immunotherapy with peanuts under the protection of anti-IgE… Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Omalizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Oct 2020
- Phase
- Phase 2
- 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 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- IgE to peanut, Ara h 1, Ara h 2 and Ara h 3
- IgE to an airborne allergen i.e. cat, dog, horse, birch, grass etc.
- Clinical allergic reactions to peanut the last 5 years
- Positive conjunctival challenge to the selected airborne allergen
- Positive CD-sens to peanut and the selected airborne allergen
- IgE according to the recommendations of the manufacturer
- Written consent
Who cannot join
- No severe diseases like renal failure, hart disease, immunodeficiency, diabetes or other severe chronic diseases
- Pregnancy
- No previous hypersensitivity reactions to sucrose, histidine, polysorbat 20 or omalizumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explorative Open Phase II-study, Food Allergy Suppression Therapy During Protection With Xolair
Severe peanut allergy is different from other allergic reactions because it can lead to fatal reactions and is an invisible disability. There is no cure today. The purpose of this study is to treat children and adolescents with severe peanut allergy with oral immunotherapy with peanuts under the protection of anti-IgE (immunoglobulin E) antibodies (omalizumab), and thereby inducing tolerance to peanuts. The treatment will be monitored by basophil cell stimulation (CD-sens).
Read the detailed description
Oral immunotherapy (OIT), where the food protein is consumed in increasing amounts, have been studied with good results, but allergic reactions has been a major problem. Anti-IgE antibodies (omalizumab) block allergy antibodies so that the allergic reaction is absent. A new test in which basophil cells stimulated with allergen in vitro, CD-sens, showing cell sensitivity, correlates well to peanut challenges.
Twenty children/adolescents, 12 to 22 years, with severe peanut allergy will be treated with omalizumab and the effect evaluated with CD-sens. If the CD-sens is negative a peanut challenge will be performed. If the challenge is negative the OIT will start: 1, 2, 4, 8 g peanuts/day in two-week intervals followed by a maintenance dose of 10 g peanuts/day while continuing treatment with omalizumab. If the CD-sens is still negative the withdrawal of omalizumab will start by halving the dose in several steps.
The study is independent of pharmaceutical companies. Omalizumab is dosed according to body mass and the amount of total IgE antibodies and therefore every individual has an individual study duration. In average the duration of the study is estimated to 52 weeks +/-40/20 weeks. Inclusion in the study is expected to last for the 2 coming years.
A treatment without serious side effects for those with severe food allergies would give a great benefit with reduced anxiety and fear, but also major health economic benefits in the form of fewer hospitalizations, sick leave, and to a greater extent completed school and education.
- Conditions
- Peanut Allergy
- Being tested
- Omalizumab
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Omalizumab is the treatment during oral immunotherapy with peanuts as protection
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Omalizumab is given to protect the study object from severe allergic reactions while they are going through oral immunotherapy with peanuts. There wïll be only one arm. The study objects are their own controls by also having allergy to airborne allergens. The dose is calculated by the study objects body mass and number of total IgE antibodies. Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peanut challenge. The peanut challenge can be positive i.e. the study object reacts to peanuts with allergic symptoms or negative i.e. no reaction in two hours after completed challenge.
Measured: The participants will be followed for the duration of Xolair treatment and oral immunotherapy, an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caroline Nilsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caroline Nilsson, Karolinska Institutet
- Investigators
- Caroline Nilsson, MD, PhD, Principal investigator, Dept of Clinical Science and Education, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402231
- Sponsor's protocol ID
- FASTXP2013
- Other IDs
- 2012-005625-78
- Acronym
- FASTX
- Status last verified
- Aug 2018
- First submitted
- 28 Nov 2013
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bjorkander S, Merid SK, Brodin D, Brandstrom J, Fagerstrom-Billai F, van der Heiden M, Konradsen JR, Kabesch M, van Drunen CM, Golebski K, Maitland-van der Zee AH, Potocnik U, Vijverberg SJH, Nopp A, Nilsson C, Melen E. Transcriptome changes during peanut oral immunotherapy and omalizumab treatment. Pediatr Allergy Immunol. 2022 Jan;33(1):e13682. doi: 10.1111/pai.13682. Epub 2021 Oct 31. No abstract available.
PubMed 34669990Brandstrom J, Vetander M, Sundqvist AC, Lilja G, Johansson SGO, Melen E, Sverremark-Ekstrom E, Nopp A, Nilsson C. Individually dosed omalizumab facilitates peanut oral immunotherapy in peanut allergic adolescents. Clin Exp Allergy. 2019 Oct;49(10):1328-1341. doi: 10.1111/cea.13469. Epub 2019 Aug 15.
PubMed 31329313Brandstrom J, Vetander M, Lilja G, Johansson SG, Sundqvist AC, Kalm F, Nilsson C, Nopp A. Individually dosed omalizumab: an effective treatment for severe peanut allergy. Clin Exp Allergy. 2017 Apr;47(4):540-550. doi: 10.1111/cea.12862. Epub 2017 Jan 10.
PubMed 27883239
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative Open Phase II-study, Food Allergy Suppression Therapy During Protection With Xolair
- ClinicalTrials.gov ID
- NCT02402231
- Acronym / sponsor ID
- FASTX / FASTXP2013
- Conditions
- Peanut Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Caroline NilssonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 30 Mar 2015 (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.
Severe peanut allergy is different from other allergic reactions because it can lead to fatal reactions and is an invisible disability. There is no cure today. The purpose of this study is to treat children and adolescents with severe peanut allergy with oral immunotherapy with peanuts under the protection of anti-IgE (immunoglobulin E) antibodies (omalizumab), and thereby inducing tolerance to peanuts. The treatment will be monitored by basophil cell stimulation (CD-sens).
Detailed description
Oral immunotherapy (OIT), where the food protein is consumed in increasing amounts, have been studied with good results, but allergic reactions has been a major problem. Anti-IgE antibodies (omalizumab) block allergy antibodies so that the allergic reaction is absent. A new test in which basophil cells stimulated with allergen in vitro, CD-sens, showing cell sensitivity, correlates well to peanut challenges.
Twenty children/adolescents, 12 to 22 years, with severe peanut allergy will be treated with omalizumab and the effect evaluated with CD-sens. If the CD-sens is negative a peanut challenge will be performed. If the challenge is negative the OIT will start: 1, 2, 4, 8 g peanuts/day in two-week intervals followed by a maintenance dose of 10 g peanuts/day while continuing treatment with omalizumab. If the CD-sens is still negative the withdrawal of omalizumab will start by halving the dose in several steps.
The study is independent of pharmaceutical companies. Omalizumab is dosed according to body mass and the amount of total IgE antibodies and therefore every individual has an individual study duration. In average the duration of the study is estimated to 52 weeks +/-40/20 weeks. Inclusion in the study is expected to last for the 2 coming years.
A treatment without serious side effects for those with severe food allergies would give a great benefit with reduced anxiety and fear, but also major health economic benefits in the form of fewer hospitalizations, sick leave, and to a greater extent completed school and education.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: OmalizumabOmalizumab is given to protect the study object from severe allergic reactions while they are going through oral immunotherapy with peanuts. There wïll be only one arm. The study objects are their own controls by also having allergy to airborne allergens. The dose is calculated by the study objects body mass and number of total IgE antibodies. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- IgE to peanut, Ara h 1, Ara h 2 and Ara h 3
- IgE to an airborne allergen i.e. cat, dog, horse, birch, grass etc.
- Clinical allergic reactions to peanut the last 5 years
- Positive conjunctival challenge to the selected airborne allergen
- Positive CD-sens to peanut and the selected airborne allergen
Key exclusion criteria (3 listed)
- No severe diseases like renal failure, hart disease, immunodeficiency, diabetes or other severe chronic diseases
- Pregnancy
- No previous hypersensitivity reactions to sucrose, histidine, polysorbat 20 or omalizumab
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 |
|---|---|---|
| OmalizumabOmalizumab is the treatment during oral immunotherapy with peanuts as protection | Drug | Omalizumab |
Primary outcome
Peanut challenge. The peanut challenge can be positive i.e. the study object reacts to peanuts with allergic symptoms or negative i.e. no reaction in two hours after completed challenge.
Time frame: The participants will be followed for the duration of Xolair treatment and oral immunotherapy, an expected average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Derived from this study: PubMed 34669990Bjorkander S, Merid SK, Brodin D, Brandstrom J, Fagerstrom-Billai F, van der Heiden M, Konradsen JR, Kabesch M, van Drunen CM, Golebski K, Maitland-van der Zee AH, Potocnik U, Vijverberg SJH, Nopp A, Nilsson C, Melen E. Transcriptome changes during peanut oral immunotherapy and omalizumab treatment. Pediatr Allergy Immunol. 2022 Jan;33(1):e13682. doi: 10.1111/pai.13682. Epub 2021 Oct 31. No abstract available.
- Derived from this study: PubMed 31329313Brandstrom J, Vetander M, Sundqvist AC, Lilja G, Johansson SGO, Melen E, Sverremark-Ekstrom E, Nopp A, Nilsson C. Individually dosed omalizumab facilitates peanut oral immunotherapy in peanut allergic adolescents. Clin Exp Allergy. 2019 Oct;49(10):1328-1341. doi: 10.1111/cea.13469. Epub 2019 Aug 15.
- Derived from this study: PubMed 27883239Brandstrom J, Vetander M, Lilja G, Johansson SG, Sundqvist AC, Kalm F, Nilsson C, Nopp A. Individually dosed omalizumab: an effective treatment for severe peanut allergy. Clin Exp Allergy. 2017 Apr;47(4):540-550. doi: 10.1111/cea.12862. Epub 2017 Jan 10.
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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.
Caroline Nilsson, MD, PhD principal investigator
Dept of Clinical Science and Education, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omalizumab in people with Peanut Allergy, run by Caroline Nilsson at 1 site in Sweden.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Aug 2018. 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 Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Peanut challenge. The peanut challenge can be positive i.e. the study object reacts to peanuts with allergic symptoms or negative i.e. no reaction in two hours after completed challenge. (time frame: The participants will be followed for the duration of Xolair treatment and oral immunotherapy, an expected average of 1 year). 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 NCT02402231, which also lists 3 linked publications.
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 24 Aug 2018.