The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery

NCT02103270 | Completed Phase 2 Results DMC

• 1 other identifier: AADCRC-STAN-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.
• 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.

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

• Passing the Week 117 DBPCFC to Peanut

  Number of Participants with No Clinical Reactivity to Peanuts

  Week 117 - Number of participants with no clinical reactivity to peanuts

Secondary Outcomes (1)

• Passing the DBPCFC to Peanut at Week 130

  Week 130

Study Arms (3)

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

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.

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.

Drug: Oat Flour; Drug: Peanut Protein 300 mg

Interventions

Peanut Protein 4,000mg DRUG

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.

Also known as: Peanut Flour

Peanut Protein 4,000mg

Oat Flour DRUG

Arm C will be defined as "natural loss of responsiveness" if they show no clinical reactivity at DBPCFCs (week 117 to end of study).

Oat Flour 600 mg; Peanut Protein 300 mg; Peanut Protein 4,000mg

Peanut Protein 300 mg DRUG

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).

Also known as: Peanut Flour

Peanut Protein 300 mg

Eligibility Criteria

• Age: 7 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Sean N. Parker Center for Allergy Research at Stanford University

Mountain View, California, 94040, United States

Location

Related Publications (5)

• 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 Jan 30. doi: 10.1111/imm.70098. Online ahead of print.

  PMID: 41615410 DERIVED

• Wang 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.

  PMID: 32783912 DERIVED

• Wright 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.

  PMID: 32434067 DERIVED

• Chinthrajah 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.

  PMID: 31522849 DERIVED

• Chinthrajah 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.

  PMID: 29709643 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Andres Alvarez Pinzon, Director of Regulatory Affairs and Translational Medicine
• Organization: The Sean N. Parker Center for Allergy Research at Stanford

andresap@stanford.edu

9544465645

Study Officials

• Kari C Nadeau, MD PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: April 3, 2014
• Study Start: April 1, 2014
• Primary Completion: July 25, 2018
• Study Completion: September 1, 2018
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Locations

US (1)