Peanut AllergyPhase 1/2PRROTECTNCT01781637
Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
A Phase 1/2 study testing Omalizumab in people with Peanut Allergy and Food Allergy, run by Boston Children's Hospital at 4 sites in United States.
Trial summary
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. Read more about this study
- Who is it for?
- Ages 7 to 25 years
- Conditions the study is for
- Peanut Allergy, Food Allergy
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to 31 May 2022
- Phase
- Phase 1/2
- 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 7 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.
- Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater)
- ImmunoCAP IgE level to peanut > 10 kU/L.
- Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.
Who cannot join
- Subjects with a total IgE at screening of < 50 kU/L > 2,000 kU/L.
- Positive reaction to the placebo on DBPCFC.
- Previous reaction to omalizumab.
- Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Division of Immunology, Children's Hospital Boston
Boston, Massachusetts, 02115
Lurie Children's Hospital
Chicago, Illinois, 60611
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Stanford University
Stanford, California, 94305
About this study
Official title: Phase 2 Study of Omalizumab in Oral Peanut Desensitization
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.
Read the detailed description
36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital.
Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.
- Conditions
- Peanut Allergy, Food Allergy
- Being tested
- Omalizumab, placebo
- Keywords
- Xolair, omalizumab, peanut, oral desensitization
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair
subcutaneous injection
placeboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| omalizumab group | Experimental | Patients will receive omalizumab. Receives: Drug: Omalizumab |
| placebo | Placebo comparator | Patients will receive placebo. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
Measured: 6 weeks after last dose of omalizumab/placebo
Secondary outcomes (1)
Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo
Measured: 12 weeks after last dose of omalizumab/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2015
- Study completion31 May 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Stanford University, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Lynda Schneider, Boston Children's Hospital
- Investigators
- Lynda C Schneider, MD, Principal investigator, Boston Children's HospitalAndrew MacGinnitie, MD, PhD, Study chair, Children' Hospital BostonKari Nadeau, MD, PhD, Study chair, Stanford UniversityJonathan Spergel, MD, PhD, Study chair, Children's Hospital of PhiladelphiaJacqueline Pongracic, MD, Study chair, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781637
- Sponsor's protocol ID
- Peanut 002
- Acronym
- PRROTECT
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2013
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chen G, Shrock EL, Li MZ, Spergel JM, Nadeau KC, Pongracic JA, Umetsu DT, Rachid R, MacGinnitie AJ, Phipatanakul W, Schneider L, Oettgen HC, Elledge SJ. High-resolution epitope mapping by AllerScan reveals relationships between IgE and IgG repertoires during peanut oral immunotherapy. Cell Rep Med. 2021 Oct 19;2(10):100410. doi: 10.1016/j.xcrm.2021.100410. eCollection 2021 Oct 19.
PubMed 34755130
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Omalizumab in Oral Peanut Desensitization
- ClinicalTrials.gov ID
- NCT01781637
- Acronym / sponsor ID
- PRROTECT / Peanut 002
- Conditions
- Peanut Allergy, Food Allergy
- Keywords
- Xolair, omalizumab, peanut, oral desensitization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Stanford University, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- Jan 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Posted 3 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.
Detailed description
36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital.
Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omalizumab group | Experimental | Drug: OmalizumabPatients will receive omalizumab. |
| placebo | Placebo comparator | Drug: placeboPatients will receive placebo. |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.
- Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater)
- ImmunoCAP IgE level to peanut > 10 kU/L.
- Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.
Key exclusion criteria (4 listed)
- Subjects with a total IgE at screening of < 50 kU/L > 2,000 kU/L.
- Positive reaction to the placebo on DBPCFC.
- Previous reaction to omalizumab.
- Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.
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: Xolairsubcutaneous injection | Drug | omalizumab group |
| placebosubcutaneous injection | Drug | placebo |
Primary outcome
Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
Time frame: 6 weeks after last dose of omalizumab/placebo
1 secondary outcome
Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo
Time frame: 12 weeks after last dose of omalizumab/placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34755130Chen G, Shrock EL, Li MZ, Spergel JM, Nadeau KC, Pongracic JA, Umetsu DT, Rachid R, MacGinnitie AJ, Phipatanakul W, Schneider L, Oettgen HC, Elledge SJ. High-resolution epitope mapping by AllerScan reveals relationships between IgE and IgG repertoires during peanut oral immunotherapy. Cell Rep Med. 2021 Oct 19;2(10):100410. doi: 10.1016/j.xcrm.2021.100410. eCollection 2021 Oct 19.
- Individual participant dataSharing planned: No
Related trials for Peanut Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Active, not recruitingPhase 2
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Peanut Allergy, Peanut Hypersensitivity
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
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.
Lynda C Schneider, MD principal investigator
Boston Children's Hospital
Andrew MacGinnitie, MD, PhD study chair
Children' Hospital Boston
Kari Nadeau, MD, PhD study chair
Stanford University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Omalizumab in people with Peanut Allergy and Food Allergy, run by Boston Children's Hospital at 4 sites 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 4 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Yes. Results are posted in the registry (first posted 3 May 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?
Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo (time frame: 6 weeks after last dose of omalizumab/placebo). 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 NCT01781637, 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 21 Feb 2023.