Trial · NCT01750879

Tolerance Following Peanut Oral Immunotherapy

NCT01750879, Phase 1, Phase 2, Completed, Massachusetts General Hospital; results first posted 2021-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Tolerance Following Peanut Oral Immunotherapy. Trials, record NCT01750879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01750879

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Tolerance Following Peanut Oral Immunotherapy
NCT number: NCT01750879
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 41 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Peanut Allergy
Interventions: Peanut Flour, Oat Flour
First posted: 2012-12-17
Last updated: 2021-07-28
Results first posted: 2021-07-28

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Tolerance, Partial Tolerance, or Treatment Failure	Average 515 days from DBPCFC1 to DBPCFC3	1. Tolerance: Ingestion of 4430 mg of peanut protein at DBPCFC3 without symptoms. 2. Partial Tolerance: ED at DBPCFC3 \<4430 mg but =\>430 mg AND \>10-fold more than at DBPCFC1. 3. Treatment Failure - non desensitized: Failure to achieve the minimum maintenance dose (600 mg) of peanut protein by 12 months, or an ED \<1443 mg at DBPCFC2, or ED at DBPCFC3 \<443 mg OR \<10-fold more than at DBPCFC1. 4. Treatment Failure - withdrawal
Secondary	Clinical: Tolerance	630 days	The change in median eliciting dose (ED) from DBPCFC1 to DBPCFC3. (note: ED right censored to maximum dose for those without any clinical reactivity)
Secondary	Clinical: Desensitization	518 days	\- The change in median eliciting dose (ED) from DBPCFC1 to DBPCFC2.
Secondary	Clinical: Safety	630 days	\- The rate of reported adverse advents due to accidental ingestions in the active versus placebo groups.
Secondary	Mechanistic: TCR Clonal Diversity	630 days	The change in the TCR clonal diversity of in vitro allergen-expanded Treg cells and induced Treg cells measured by TCRB CDR3 sequence clonotyping of sorted cells during active treatment among participants who achieve increased clinical tolerance (Tolerance and Partial Tolerance Groups as defined in clinical endpoints) versus the Treatment Failure Group. We conducted a nested case-control analysis of a subset of actively treated (by treatment outcome) versus placebo treated patients. Genomic DNA was used to amplify and sequence the complementarity-determining region 3 (CDR3) regions (immunoSEQ assay; Adaptive Biotechnologies). Enriched clonotypes in the CD154+ fraction (doi: https://doi.org/10.1101/2020.05.11.088286) were analyzed for differences by Rank Abundance Curve analysis (R package alakazam; Chao A, et al. Ecology. 2015 96, 11891201) to determine differences in clonal diversity.
Secondary	Mechanistic: Change Eliciting Dose of End-point Dilution.	518 days	The change in eliciting dose of end-point dilution skin testing between actively treated and placebo treated participants following maintenance therapy and the change in ED of end-point dilution skin testing among actively treated participants following maintenance therapy and avoidance between clinical outcome groups.
Secondary	Mechanistic: Change in Basophil Eliciting Dose.	630 days	The change in peanut-specific basophil ED in actively treated participants at the end of maintenance and the end of avoidance between clinical outcome groups.
Secondary	Mechanistic: Change in Peanut Allergen-specific IgG4	518 days	The change in peanut allergen-specific IgG4 in actively treated participants by the end of maintenance between clinical outcome groups.
Secondary	Mechanistic: Significant Gene Expression Changes by Transcriptional Profiling of Regulatory and Effector T Cell Populations	630 days	Statistically significant gene expression changes (as number of genes) by transcriptional profiling of regulatory and effector T cell populations before and after OIT between clinical outcome groups. Total RNA from CD154+ and CD154-CD69- T cells was used for cDNA synthesis and amplification. Libraries were prepared and sequenced to a read depth of approximately 30 million reads per sample (Illumina HiSeq) and aligned to the hg19 human reference genome with the ensemble version 75 annotation using STAR version 2.5.3a,(Dobin et al. Bioinformatics 2013) and gene expression was summarized using RSEM version 1.3.0 (Li et al. BMC Bioinform 2013). Differential expression analysis was performed using DESeq2 v 1.30.1 (R v 4.04). Significance level was set at an unadjusted P value less than .001.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Tolerance, Partial Tolerance, or Treatment Failure	Average 515 days from DBPCFC1 to DBPCFC3		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical: Tolerance	630 days	Per protocol, subjects were unblinded after DBPCFC2 and those on placebo were not subjected to DBPCFC3	mg	MEDIAN
SECONDARY	Clinical: Desensitization	518 days	30 active and 11 placebo had baseline challenge (DBPCFC1); 20 active and 8 placebo had first post-treatment challenge (DBPCFC2). Change in median eliciting dose restricted to the 20 and 8 who competed DBPCFC2 (i.e., per protocol)	mg	MEDIAN
SECONDARY	Clinical: Safety	630 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mechanistic: TCR Clonal Diversity	630 days	We conducted a nested case-control analysis of a subset of actively treated (by treatment outcome) versus placebo treated patients. Genomic DNA was used to amplify and sequence the complementarity-determining region 3 (CDR3) regions (immunoSEQ assay; Adaptive Biotechnologies). Enriched clonotypes in the CD154+ fraction (doi: https://doi.org/10.1101/2020.05.11.088286) were analyzed for differences by Rank Abundance Curve analysis (R package alakazam; Chao A, et al. Ecology. 2015 96, 11891201).	percentage of clones	MEAN
SECONDARY	Mechanistic: Change Eliciting Dose of End-point Dilution.	518 days	skin test quality was poor
SECONDARY	Mechanistic: Change in Basophil Eliciting Dose.	630 days	basophil time points inadequate for analysis
SECONDARY	Mechanistic: Change in Peanut Allergen-specific IgG4	518 days		mg/mL	MEAN
SECONDARY	Mechanistic: Significant Gene Expression Changes by Transcriptional Profiling of Regulatory and Effector T Cell Populations	630 days	Subjects as defined per protocol. All 5 placebo were 'treatment failure -- non-desensitized' and per protocol, none were eligible for avoidance or DBPCFC3.~Total RNA from CD154+ and CD154-CD69- T cells was used for cDNA synthesis and amplification. Read depth of approximately 30 million per sample (Illumina HiSeq) and aligned to the hg19 human reference genome with the ensemble version 75 annotation. Differential expression analysis was performed using DESeq2 v 1.30.1 (R v 4.04).	number of differentially expressed genes	NUMBER

Source ClinicalTrials.gov

Results by group35

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Tolerance, Partial Tolerance, or Treatment Failure	Active	Tolerance	5		Participants
Tolerance, Partial Tolerance, or Treatment Failure	Placebo	Tolerance	0		Participants
Tolerance, Partial Tolerance, or Treatment Failure	Active	Partial Tolerance	8		Participants
Tolerance, Partial Tolerance, or Treatment Failure	Placebo	Partial Tolerance	0		Participants
Tolerance, Partial Tolerance, or Treatment Failure	Active	Treatment Failure- non-desensitized	7		Participants
Tolerance, Partial Tolerance, or Treatment Failure	Placebo	Treatment Failure- non-desensitized	8		Participants
Tolerance, Partial Tolerance, or Treatment Failure	Active	Treatment Failure- withdrawal	10		Participants
Tolerance, Partial Tolerance, or Treatment Failure	Placebo	Treatment Failure- withdrawal	3		Participants
Clinical: Tolerance	Peanut Flour		4000	Full Range -403 to 4400	mg
Clinical: Desensitization	Peanut Flour		4000	Full Range -3 to 4400	mg

1 to 10 of 35Source ClinicalTrials.gov

See all 35 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Peanut Flour	30
Overall Study	STARTED	Placebo (Oat) Flour	11
Overall Study	DBPCFC2	Peanut Flour	20
Overall Study	DBPCFC2	Placebo (Oat) Flour	8
Overall Study	DBPCFC3	Peanut Flour	20
Overall Study	DBPCFC3	Placebo (Oat) Flour	0
Overall Study	COMPLETED	Peanut Flour	20
Overall Study	COMPLETED	Placebo (Oat) Flour	8
Overall Study	NOT COMPLETED	Peanut Flour	10
Overall Study	NOT COMPLETED	Placebo (Oat) Flour	3

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaphylactic Reaction	Immune system disorders	Peanut Flour	5	30	12
other	Anaphylactic Reaction	Immune system disorders	Oat Flour	1	11	1
other	Abdominal Pain	Gastrointestinal disorders	Peanut Flour	1	30	1
other	Abdominal Pain	Gastrointestinal disorders	Oat Flour	0	11	0
other	Nausea/Vomting	Gastrointestinal disorders	Peanut Flour	1	30	1
other	Nausea/Vomting	Gastrointestinal disorders	Oat Flour	0	11	0
other	Urticaria	Skin and subcutaneous tissue disorders	Peanut Flour	1	30	2
other	Urticaria	Skin and subcutaneous tissue disorders	Oat Flour	0	11	0
other	Anaphylactic Reaction	Immune system disorders	Peanut Flour	15	30	89
other	Anaphylactic Reaction	Immune system disorders	Oat Flour	0	11	0

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Peanut Flour	0	30
Total, all-cause mortality	Oat Flour	0	11
Total, other adverse events	Peanut Flour	30	30
Total, other adverse events	Oat Flour	11	11
Total, serious adverse events	Peanut Flour	1	30
Total, serious adverse events	Oat Flour	0	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34813505	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U19AI095261	T cell effector and regulatory mechanisms in asthma and food allergy	LUSTER, ANDREW D	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2011 to 2015

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Peanut Flour vs Placebo (Oat) Flour: Clinical: Safety	Trial comparisons
Peanut Flour vs Oat Flour: deaths from any cause	Trial comparisons
Peanut Flour vs Oat Flour: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01750879

GET https://conductscience.org/api/trials/v1/NCT01750879/results?page=2

API reference For AI assistants