Peanut AllergyPhase 2POISEDNCT02103270
The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery
A Phase 2 study testing Peanut Protein 4,000mg, Oat Flour and Peanut Protein 300 mg in people with Peanut Allergy, run by Stanford University at 1 site in United States.
Trial summary
Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period Secondary Objectives: Identify the basic immune mechanisms which can explain the differences in the effects of OIT in desensitized vs. tolerant individuals. Read more about this study
- Who is it for?
- Ages 7 to 55 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut Protein 4,000mg, Oat Flour and Peanut Protein 300 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 1 Sep 2018
- Phase
- Phase 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 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject and/or parent guardian must be able to understand and provide informed consent and/or assent as applicable.
- Peanut-allergic subjects between the ages of 7-55 years old.
- Sensitivity to peanut allergen as documented by a positive skin prick test result (5 mm or greater diameter wheal relative to negative control) within 10 months preceding enrollment.
- Allergy to peanut based on a double-blind placebo-controlled oral food challenge (DBPCFC) (see Appendix 4 for scoring details) failed at a dose ≤500 mg with peanut protein within 10 months preceding enrollment.
- All female subjects of child-bearing potential will be required to provide a blood or urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
- Subjects must plan to remain in the study area during the trial.
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- Subjects must be trained on the proper use of the EpiPen (see Appendix 6) to be allowed to enroll in the study.
- Subjects with other food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study.
- Use of birth control by female subjects of child-bearing potential
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- History of cardiovascular disease
- History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis) requiring therapy (e.g., heart disease, diabetes) that, in the opinion of the Principal Investigator, would represent a risk to the subject's health or safety in this study or the subject's ability to comply with the study protocol
- History of eosinophilic gastrointestinal disease
- Current participation in any other interventional study
- Subject is on 'build-up phase" of immunotherapy to another allergen (i.e., has not reached maintenance dosing)
Show all 16Show fewer
- Severe asthma (2007 NHLBI Criteria Steps 5 or 6) at time of enrollment
- • Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal remedies) for atopic and/or non-atopic disease within 90 days preceding Initial Dose Escalation Day (IDED) or at any time after the IDED
- Inability to discontinue antihistamines for the initial day of escalation, skin testing or OFCs
- Use of omalizumab within the past six months, or current use of other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids)
- Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- Pregnancy or lactation
- History of sensitivity to oat
- History of severe anaphylaxis to peanut with symptoms including hypotension requiring fluid resuscitation and/or the need for mechanical ventilation
- Use of investigational drugs within 24 weeks of participation
- Past or current medical problems or findings from physical assessment or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sean N. Parker Center for Allergy Research at Stanford University
Mountain View, California, 94040
About this study
Official title: Single Center, Placebo Controlled Clinical Study in Desensitization vs Tolerance Induction in Peanut Allergy Subjects
Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period
Secondary Objectives:
- Identify the basic immune mechanisms which can explain the differences in the effects of OIT in desensitized vs. tolerant individuals.
- Determine whether immune monitoring measurements reflecting underlying mechanisms during OIT can be used to predict responses to OIT in individual subjects and, ultimately, to improve the safety and efficacy outcomes in peanut OIT protocols.
Read the detailed description
All arms will undergo an Initial Dose Escalation (IDE) Day and updosing regimen with a maintenance phase of OIT or placebo to a maximum of 4,000 mg protein daily, as peanut flour, in the OIT groups, and to a maximum of an equivalent amount of oat flour for the placebo group. After maintenance is achieved, all subjects will begin performing DBPCFCs (staged so as to ensure safety) at Week 104 and every 13 weeks thereafter. At Week 104, individuals that reach criteria will, based on the randomization that was done at the start of the study, either stop therapy with peanut and be switched to oat flour, or will be maintained on 300 mg peanut protein per day and all placebo subjects will decrease to the equivalent volume of oat flour (approximately 600 mg oat flour) to optimize the blind. All subjects will be evaluated every 13 weeks thereafter with DBPCFCs until the end of study.
Individuals in Arm A will be defined as "clinically tolerant" if there is no clinical reactivity at the Week 104 and Week 117 DBPCFC. Clinical reactivity is defined as any reaction ≥ Grade 1 based on the Bock's Criteria. Individuals in Arm A who meet the definition of "clinically tolerant" will continue to avoid peanut protein (i.e. continue on 600 mg per day of oat flour) as long as each subsequent DBPCFC (performed every 13 weeks until end of study) shows no clinical reactivity.
Individuals in Arm B will be defined as "desensitized" to a minimum of 300 mg per day of peanut protein if they show no clinical reactivity at DBPCFCs (week 117 to end of study).
Individuals in Arm C will be defined as "natural loss of responsiveness" if they show no clinical reactivity at DBPCFCs (week 117 to end of study).
We plan to identify the basic immune mechanisms which can explain the differences in the effects of OIT in individuals who do or do not become clinically tolerant and to determine whether immune monitoring can predict the safety and efficacy outcomes in peanut OIT protocols.
After initial screening and enrollment, there are three phases of the study:
- Dose escalation and Build up Phase
- Maintenance phase
- Tolerance and Desensitization Testing phase Overall, 120 subjects who are eligible will undergo the Initial Dose Escalation Day. Subsequent updosing visits will occur every 2 weeks as a part of the build-up phase. They will continue to updose until they reach 4,000 mg protein daily, which is the maximum maintenance amount of protein. We expect active OIT treatment subjects to reach 4,000 mg of peanut protein between 44-78 weeks.
Treatment and Desensitization Failures:
A treatment failure will be defined as a) failure to reach 1.5 mg peanut protein (single dose) during the Initial Dose Escalation Day or b) failure to reach 1,000 mg peanut protein by week 104.
Subjects who do not meet the criteria at Week 104 and who demonstrate clinical reactivity will be considered desensitization failures.
If Arm B subjects demonstrate clinical reactivity in any DBPCFC from Week 117 to end of study, they will be considered desensitization failures.
If Arm A subjects demonstrate clinical reactivity (≥Grade 1, in any DBPCFC from Week 117 to end of study, they will be considered tolerance failures.
Treatment failures, desensitization failures, and tolerance failures will be unblinded (both participant and research staff) and will be followed until the end of the study at the specified study visits but will not undergo DBPCFCs. They will be considered in statistical analyses of the intent-to-treat population.
- Conditions
- Peanut Allergy
- Being tested
- Peanut Protein 4,000mg, Oat Flour, Peanut Protein 300 mg
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut Protein 4,000mgDrug
Also called Peanut Flour
Arm A will be defined as "clinically tolerant" if there is no clinical reactivity at the Week 104 and Week 117 DBPCFC. Clinical reactivity is defined as any reaction ≥ Grade 1 based on the Bock's Criteria (Appendix 4). Individuals in Arm A who meet the definition of "clinically tolerant" will continue to avoid peanut protein (i.e. continue on 600 mg per day of oat flour) as long as each subsequent DBPCFC (performed every 13 weeks until end of study) shows no clinical reactivity.
Oat FlourDrug
Arm C will be defined as "natural loss of responsiveness" if they show no clinical reactivity at DBPCFCs (week 117 to end of study).
Peanut Protein 300 mgDrug
Also called Peanut Flour
Arm B will be defined as "desensitized" to a minimum of 300 mg per day of peanut protein if they show no clinical reactivity at DBPCFCs (week 117 to end of study).
| Study group | Role | What they receive |
|---|---|---|
| Oat Flour 600 mg | Placebo comparator | Arm C that is maintained on placebo (oat flour) throughout the study; this arm will receive 600 mg oat flour beginning on week 104. This will be true even if a subject in the placebo group meets criteria at week 104 Receives: Drug: Oat Flour |
| Peanut Protein 4,000mg | Active comparator | Arm A on peanut OIT until week 104 (maintenance) and once meeting criteria [i.e. 1) on OIT treatment for minimum 104 weeks, 2) taking daily maintenance dose of 4,000 mg protein for at least 13 weeks, 3) no severe reactions to home dosing from Week 91-Week 104, and 4) no reactions at the Week 104 DBPCFC] will be assigned to avoid peanut (i.e. will consume 600 mg oat flour daily) and will proceed to tolerance and desensitization phase. Receives: Drug: Peanut Protein 4,000mg; Drug: Oat Flour |
| Peanut Protein 300 mg | Active comparator | Arm B on peanut OIT until week 104 and once meeting criteria specified in description of Arm A, will be assigned to be maintained on 300 mg peanut protein (i.e. 600 mg peanut flour) daily and will proceed to the tolerance and desensitization testing phase. Receives: Drug: Oat Flour; Drug: Peanut Protein 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passing the Week 117 DBPCFC to Peanut
Number of Participants with No Clinical Reactivity to Peanuts
Measured: Week 117 - Number of participants with no clinical reactivity to peanuts
Secondary outcomes (1)
Passing the DBPCFC to Peanut at Week 130
Secondary endpoint: Passing the DBPCFC to peanut at 130 weeks
Measured: Week 130
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion25 Jul 2018
- Study completion1 Sep 2018
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 (5)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 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari Christine Nadeau, MD PhD, Stanford University
- Investigators
- Kari C Nadeau, MD PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103270
- Sponsor's protocol ID
- AADCRC-STAN-001
- Acronym
- POISED
- Status last verified
- Aug 2019
- First submitted
- 25 Mar 2014
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kanchan K, Cerosaletti K, Perry JA, DuToit G, Manohar M, Ling H, Paschall JE, Sanda S, Chinthrajah RS, Nepom GT, Nadeau KC, Jones SM, Lack G, Ruczinski I, Mathias RA. Genetic Determinants of Peanut-Specific IgG4 Levels in the Context of Sustained Oral Peanut Exposure in the LEAP Study. Immunology. 2026 Jun;178(2):280-292. doi: 10.1111/imm.70098. Epub 2026 Jan 30.
PubMed 41615410Wang W, Lyu SC, Ji X, Gupta S, Manohar M, Dhondalay GKR, Chinthrajah S, Andorf S, Boyd SD, Tibshirani R, Galli SJ, Nadeau KC, Maecker HT. Transcriptional changes in peanut-specific CD4+ T cells over the course of oral immunotherapy. Clin Immunol. 2020 Oct;219:108568. doi: 10.1016/j.clim.2020.108568. Epub 2020 Aug 9.
PubMed 32783912Wright BL, Fernandez-Becker NQ, Kambham N, Purington N, Cao S, Tupa D, Zhang W, Sindher SB, Rank MA, Kita H, Katzka DA, Shim KP, Bunning BJ, Doyle AD, Jacobsen EA, Tsai M, Boyd SD, Manohar M, Chinthrajah RS. Gastrointestinal Eosinophil Responses in a Longitudinal, Randomized Trial of Peanut Oral Immunotherapy. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1151-1159.e14. doi: 10.1016/j.cgh.2020.05.019. Epub 2020 May 17.
PubMed 32434067Chinthrajah RS, Purington N, Andorf S, Long A, O'Laughlin KL, Lyu SC, Manohar M, Boyd SD, Tibshirani R, Maecker H, Plaut M, Mukai K, Tsai M, Desai M, Galli SJ, Nadeau KC. Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2019 Oct 19;394(10207):1437-1449. doi: 10.1016/S0140-6736(19)31793-3. Epub 2019 Sep 12.
PubMed 31522849Chinthrajah RS, Purington N, Andorf S, Rosa JS, Mukai K, Hamilton R, Smith BM, Gupta R, Galli SJ, Desai M, Nadeau KC. Development of a tool predicting severity of allergic reaction during peanut challenge. Ann Allergy Asthma Immunol. 2018 Jul;121(1):69-76.e2. doi: 10.1016/j.anai.2018.04.020. Epub 2018 Apr 27.
PubMed 29709643
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Placebo Controlled Clinical Study in Desensitization vs Tolerance Induction in Peanut Allergy Subjects
- ClinicalTrials.gov ID
- NCT02103270
- Acronym / sponsor ID
- POISED / AADCRC-STAN-001
- Conditions
- Peanut Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2014 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Posted 4 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period
Secondary Objectives:
- Identify the basic immune mechanisms which can explain the differences in the effects of OIT in desensitized vs. tolerant individuals.
- Determine whether immune monitoring measurements reflecting underlying mechanisms during OIT can be used to predict responses to OIT in individual subjects and, ultimately, to improve the safety and efficacy outcomes in peanut OIT protocols.
Detailed description
All arms will undergo an Initial Dose Escalation (IDE) Day and updosing regimen with a maintenance phase of OIT or placebo to a maximum of 4,000 mg protein daily, as peanut flour, in the OIT groups, and to a maximum of an equivalent amount of oat flour for the placebo group. After maintenance is achieved, all subjects will begin performing DBPCFCs (staged so as to ensure safety) at Week 104 and every 13 weeks thereafter. At Week 104, individuals that reach criteria will, based on the randomization that was done at the start of the study, either stop therapy with peanut and be switched to oat flour, or will be maintained on 300 mg peanut protein per day and all placebo subjects will decrease to the equivalent volume of oat flour (approximately 600 mg oat flour) to optimize the blind. All subjects will be evaluated every 13 weeks thereafter with DBPCFCs until the end of study.
Individuals in Arm A will be defined as "clinically tolerant" if there is no clinical reactivity at the Week 104 and Week 117 DBPCFC. Clinical reactivity is defined as any reaction ≥ Grade 1 based on the Bock's Criteria. Individuals in Arm A who meet the definition of "clinically tolerant" will continue to avoid peanut protein (i.e. continue on 600 mg per day of oat flour) as long as each subsequent DBPCFC (performed every 13 weeks until end of study) shows no clinical reactivity.
Individuals in Arm B will be defined as "desensitized" to a minimum of 300 mg per day of peanut protein if they show no clinical reactivity at DBPCFCs (week 117 to end of study).
Individuals in Arm C will be defined as "natural loss of responsiveness" if they show no clinical reactivity at DBPCFCs (week 117 to end of study).
We plan to identify the basic immune mechanisms which can explain the differences in the effects of OIT in individuals who do or do not become clinically tolerant and to determine whether immune monitoring can predict the safety and efficacy outcomes in peanut OIT protocols.
After initial screening and enrollment, there are three phases of the study:
- Dose escalation and Build up Phase
- Maintenance phase
- Tolerance and Desensitization Testing phase Overall, 120 subjects who are eligible will undergo the Initial Dose Escalation Day. Subsequent updosing visits will occur every 2 weeks as a part of the build-up phase. They will continue to updose until they reach 4,000 mg protein daily, which is the maximum maintenance amount of protein. We expect active OIT treatment subjects to reach 4,000 mg of peanut protein between 44-78 weeks.
Treatment and Desensitization Failures:
A treatment failure will be defined as a) failure to reach 1.5 mg peanut protein (single dose) during the Initial Dose Escalation Day or b) failure to reach 1,000 mg peanut protein by week 104.
Subjects who do not meet the criteria at Week 104 and who demonstrate clinical reactivity will be considered desensitization failures.
If Arm B subjects demonstrate clinical reactivity in any DBPCFC from Week 117 to end of study, they will be considered desensitization failures.
If Arm A subjects demonstrate clinical reactivity (≥Grade 1, in any DBPCFC from Week 117 to end of study, they will be considered tolerance failures.
Treatment failures, desensitization failures, and tolerance failures will be unblinded (both participant and research staff) and will be followed until the end of the study at the specified study visits but will not undergo DBPCFCs. They will be considered in statistical analyses of the intent-to-treat population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oat Flour 600 mg | Placebo comparator | Drug: Oat FlourArm C that is maintained on placebo (oat flour) throughout the study; this arm will receive 600 mg oat flour beginning on week 104. This will be true even if a subject in the placebo group meets criteria at week 104 |
| Peanut Protein 4,000mg | Active comparator | Drug: Peanut Protein 4,000mg, Drug: Oat FlourArm A on peanut OIT until week 104 (maintenance) and once meeting criteria [i.e. 1) on OIT treatment for minimum 104 weeks, 2) taking daily maintenance dose of 4,000 mg protein for at least 13 weeks, 3) no severe reactions to home dosing from Week 91-Week 104, and 4) no reactions at the Week 104 DBPCFC] will be assigned to avoid peanut (i.e. will consume 600 mg oat flour daily) and will proceed to tolerance and desensitization phase. |
| Peanut Protein 300 mg | Active comparator | Drug: Oat Flour, Drug: Peanut Protein 300 mgArm B on peanut OIT until week 104 and once meeting criteria specified in description of Arm A, will be assigned to be maintained on 300 mg peanut protein (i.e. 600 mg peanut flour) daily and will proceed to the tolerance and desensitization testing phase. |
Who may qualify
- Ages
- 7 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Subject and/or parent guardian must be able to understand and provide informed consent and/or assent as applicable.
- Peanut-allergic subjects between the ages of 7-55 years old.
- Sensitivity to peanut allergen as documented by a positive skin prick test result (5 mm or greater diameter wheal relative to negative control) within 10 months preceding enrollment.
- Allergy to peanut based on a double-blind placebo-controlled oral food challenge (DBPCFC) (see Appendix 4 for scoring details) failed at a dose ≤500 mg with peanut protein within 10 months preceding enrollment.
- All female subjects of child-bearing potential will be required to provide a blood or urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
Key exclusion criteria (16 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- History of cardiovascular disease
- History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis) requiring therapy (e.g., heart disease, diabetes) that, in the opinion of the Principal Investigator, would represent a risk to the subject's health or safety in this study or the subject's ability to comply with the study protocol
- History of eosinophilic gastrointestinal disease
- Current participation in any other interventional study
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 |
|---|---|---|
| Peanut Protein 4,000mgAlso: Peanut FlourArm A will be defined as "clinically tolerant" if there is no clinical reactivity at the Week 104 and Week 117 DBPCFC. Clinical reactivity is defined as any reaction ≥ Grade 1 based on the Bock's Criteria (Appendix 4). Individuals in Arm A who meet the definition of "clinically tolerant" will continue to avoid peanut protein (i.e. continue on 600 mg per day of oat flour) as long as each subsequent DBPCFC (performed every 13 weeks until end of study) shows no clinical reactivity. | Drug | Peanut Protein 4,000mg |
| Oat FlourArm C will be defined as "natural loss of responsiveness" if they show no clinical reactivity at DBPCFCs (week 117 to end of study). | Drug | Oat Flour 600 mg, Peanut Protein 300 mg, Peanut Protein 4,000mg |
| Peanut Protein 300 mgAlso: Peanut FlourArm B will be defined as "desensitized" to a minimum of 300 mg per day of peanut protein if they show no clinical reactivity at DBPCFCs (week 117 to end of study). | Drug | Peanut Protein 300 mg |
Primary outcome
Passing the Week 117 DBPCFC to Peanut
Time frame: Week 117 - Number of participants with no clinical reactivity to peanuts
Number of Participants with No Clinical Reactivity to Peanuts
1 secondary outcome
Passing the DBPCFC to Peanut at Week 130
Time frame: Week 130
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41615410Kanchan K, Cerosaletti K, Perry JA, DuToit G, Manohar M, Ling H, Paschall JE, Sanda S, Chinthrajah RS, Nepom GT, Nadeau KC, Jones SM, Lack G, Ruczinski I, Mathias RA. Genetic Determinants of Peanut-Specific IgG4 Levels in the Context of Sustained Oral Peanut Exposure in the LEAP Study. Immunology. 2026 Jun;178(2):280-292. doi: 10.1111/imm.70098. Epub 2026 Jan 30.
- Derived from this study: PubMed 32783912Wang W, Lyu SC, Ji X, Gupta S, Manohar M, Dhondalay GKR, Chinthrajah S, Andorf S, Boyd SD, Tibshirani R, Galli SJ, Nadeau KC, Maecker HT. Transcriptional changes in peanut-specific CD4+ T cells over the course of oral immunotherapy. Clin Immunol. 2020 Oct;219:108568. doi: 10.1016/j.clim.2020.108568. Epub 2020 Aug 9.
- Derived from this study: PubMed 32434067Wright BL, Fernandez-Becker NQ, Kambham N, Purington N, Cao S, Tupa D, Zhang W, Sindher SB, Rank MA, Kita H, Katzka DA, Shim KP, Bunning BJ, Doyle AD, Jacobsen EA, Tsai M, Boyd SD, Manohar M, Chinthrajah RS. Gastrointestinal Eosinophil Responses in a Longitudinal, Randomized Trial of Peanut Oral Immunotherapy. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1151-1159.e14. doi: 10.1016/j.cgh.2020.05.019. Epub 2020 May 17.
- Derived from this study: PubMed 31522849Chinthrajah RS, Purington N, Andorf S, Long A, O'Laughlin KL, Lyu SC, Manohar M, Boyd SD, Tibshirani R, Maecker H, Plaut M, Mukai K, Tsai M, Desai M, Galli SJ, Nadeau KC. Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2019 Oct 19;394(10207):1437-1449. doi: 10.1016/S0140-6736(19)31793-3. Epub 2019 Sep 12.
- Derived from this study: PubMed 29709643Chinthrajah RS, Purington N, Andorf S, Rosa JS, Mukai K, Hamilton R, Smith BM, Gupta R, Galli SJ, Desai M, Nadeau KC. Development of a tool predicting severity of allergic reaction during peanut challenge. Ann Allergy Asthma Immunol. 2018 Jul;121(1):69-76.e2. doi: 10.1016/j.anai.2018.04.020. Epub 2018 Apr 27.
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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.
Kari C Nadeau, MD PhD 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 Phase 2 study testing Peanut Protein 4,000mg, Oat Flour and Peanut Protein 300 mg in people with Peanut 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?
The sponsor lists 9 inclusion and 16 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 4 Sep 2019. 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. 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 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?
Yes. Results are posted in the registry (first posted 4 Sep 2019). 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?
Passing the Week 117 DBPCFC to Peanut (time frame: Week 117 - Number of participants with no clinical reactivity to peanuts). 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 NCT02103270, which also lists 5 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 4 Sep 2019.