Peanut Oral Immunotherapy in Children | NCT01867671

NCT01867671

Status Module

Sponsor/Collaborators Module

Name	Class
Immune Tolerance Network (ITN)	NETWORK

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peanut Oral Immune Therapy (OIT)	Experimental	Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.	Biological: Peanut Oral Immunotherapy - Liquid Extract Biological: Peanut Oral Immunotherapy - Peanut Flour
Peanut Placebo	Placebo Comparator	Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract will be derived from oat flour source material.	Biological: Placebo for Peanut Oral Immunotherapy - Liquid Extract form Biological: Placebo for Peanut Oral Immunotherapy - Peanut Flour

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peanut Oral Immunotherapy - Liquid Extract	Biological	Used during initial dose escalation for doses 0.1 to 0.8 mg.	Peanut Oral Immune Therapy (OIT)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)	Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.* *Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.	Week 134

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Tolerant Participants at Week 160	Definition of Tolerant: A participant who passed the oral food challenge (OFC) to 10 grams of peanut flour (=5 grams of peanut protein).	Week 160
Count of Participants With Transient Desensitization

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut;
Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro test system for diagnosis and monitoring of allergy and inflammation;
Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;
A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein) during screening OFC;
Written informed consent from parent/guardian.

Exclusion Criteria:

History of severe anaphylaxis with hypotension to peanut;
Documented clinical history of allergy to oat;
Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared to a negative control;
Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes;
Active eosinophilic gastrointestinal disease in the past 2 years;
Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1;
Inhalant allergen immunotherapy that has not yet reached maintenance dosing;
Severe asthma, as indicated by repeated hospitalizations or hospital emergency department visits;
Moderate asthma defined according to National Asthma Education and Prevention Program Expert;
Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate control;
Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation;
Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1;
Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic corticosteroid therapy of up to a total of three weeks is allowed;
Use of any investigational drug in 90 days prior to visit -1;
Plan to use any investigational drug during the study period;
The presence of any medical condition that the investigator deems incompatible with participation in the trial.

Contacts/Locations Module

Name	Affiliation	Role
Wesley Burks, MD	UNC Chapel-Hill	Study Chair
Stacie M. Jones, MD	University of Arkansas	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences: Arkansas Children's Hospital		Little Rock	Arkansas	72202	United States

References Module

Label	URL
National Institute of Allergy and Infectious Diseases (NIAID) website	View source
Division of Allergy, Immunology, and Transplantation (DAIT) website	View source
Immune Tolerance Network website

ID	Title	Description
FG000	Peanut Oral Immune Therapy (OIT)	Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 28, 2017

ID	Title	Description
BG000	Peanut Oral Immune Therapy (OIT)	Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
BG001	Peanut Placebo	Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00096 BG00150 BG002146

Categories

Title	Measurements
	BG0003.1± 0.7 BG0013.0± 0.8 BG0023.1± 0.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00030 BG00118 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00096 BG00150 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)

Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.*

*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.

Posted

Number

95% Confidence Interval

Percentage of Participants

Week 134

ID	Title	Description
OG000	Peanut Oral Immune Therapy (OIT)	Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
OG001	Peanut Placebo	Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.

Units	Counts
Participants	OG00096 OG00150

Title

Denominators

Categories

Title	Measurements
	OG00071(61.7 to 79.9) OG0012(0.0 to 5.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		<0.0001		Odds Ratio (OR)	205.45			2-Sided	95	24.00	1758.51					Superiority

Secondary

Percentage of Tolerant Participants at Week 160

Definition of Tolerant: A participant who passed the oral food challenge (OFC) to 10 grams of peanut flour (=5 grams of peanut protein).

Posted

Number

95% Confidence Interval

percentage of participants

Week 160

ID	Title	Description
OG000	Peanut Oral Immune Therapy (OIT)	Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
OG001	Peanut Placebo	Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.

Units	Counts
Participants

Secondary

Count of Participants With Transient Desensitization

Participants randomized to the Peanut Oral Immunotherapy (OIT) group

Posted

Count of Participants

Participants

Week 134, Week 160

ID	Title	Description
OG000	Peanut Oral Immune Therapy (OIT)	Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.

Units	Counts
Participants	OG000

Secondary

Highest Tolerated Cumulative Dose

The highest tolerated cumulative dose of peanut protein during the blinded (masked) oral food challenge (OFC) at Week 160, analyzed within and between both placebo and peanut OIT groups. The highest cumulative dose of peanut protein tolerated for each participant was analyzed as a continuous outcome.

Any randomized participant without an evaluable blinded (masked) OFC was imputed as not tolerant. For the continuous highest cumulative dose endpoint, this is defined as having a highest cumulative dose imputed as zero.

Posted

Mean

95% Confidence Interval

mg protein

Week 160

ID	Title	Description
OG000	Peanut Oral Immune Therapy (OIT)	Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
OG001	Peanut Placebo	Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.

Secondary

Percentage of Participants That Withdrew From the Study

Percentage of participants that withdrew from study participation, listed by study phase (at time of study withdrawal).

Posted

Number

percentage of participants

Initial Dose Escalation through Week 160 (Tolerance Assessment)

ID	Title	Description
OG000	Peanut Oral Immune Therapy (OIT)	Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
OG001	Peanut Placebo	Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Peanut Oral Immunotherapy (OIT)	Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.	0	96	3	96	96	96
EG001	Peanut Placebo	Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract was derived from oat flour source material.	0	50	4	50	50	50

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA V16.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected50 at risk
Anaphylactic reaction	Immune system disorders	MedDRA V16.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected50 at risk
Pyelonephritis	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected50 at risk
Respiratory tract infection	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected50 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA V16.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected50 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA V16.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected50 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear pain	Ear and labyrinth disorders	MedDRA V16.0	Systematic Assessment	EG0009 events4 affected96 at risk EG0013 events3 affected50 at risk
Conjunctivitis	Eye disorders	MedDRA V16.0	Systematic Assessment	EG0008 events6 affected96 at risk EG0019 events5 affected50 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA V16.0	Systematic Assessment	EG00048 events18 affected96 at risk EG0016 events4 affected50 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA V16.0	Systematic Assessment	EG000105 events29 affected96 at risk EG00118 events5 affected50 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA V16.0	Systematic Assessment	EG00026 events10 affected96 at risk EG0014 events2 affected50 at risk
Constipation	Gastrointestinal disorders	MedDRA V16.0	Systematic Assessment	EG0008 events8 affected96 at risk EG0018 events7 affected50 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA V16.0	Systematic Assessment	EG00026 events20 affected96 at risk EG00120 events12 affected50 at risk
Gastritis	Gastrointestinal disorders	MedDRA V16.0	Systematic Assessment	EG00019 events13 affected96 at risk EG00115 events5 affected50 at risk
Lip pruritus	Gastrointestinal disorders	MedDRA V16.0	Systematic Assessment	EG00010 events5 affected96 at risk EG0010 events0 affected50 at risk
Vomiting	Gastrointestinal disorders	MedDRA V16.0	Systematic Assessment	EG00080 events45 affected96 at risk EG00132 events19 affected50 at risk
Influenza like illness	General disorders	MedDRA V16.0	Systematic Assessment	EG00078 events20 affected96 at risk EG00127 events8 affected50 at risk
Pyrexia	General disorders	MedDRA V16.0	Systematic Assessment	EG000190 events65 affected96 at risk EG001108 events29 affected50 at risk
Allergy to animal	Immune system disorders	MedDRA V16.0	Systematic Assessment	EG00015 events6 affected96 at risk EG0016 events3 affected50 at risk
Food allergy	Immune system disorders	MedDRA V16.0	Systematic Assessment	EG000135 events85 affected96 at risk EG00172 events43 affected50 at risk
Hypersensitivity	Immune system disorders	MedDRA V16.0	Systematic Assessment	EG00077 events39 affected96 at risk EG00125 events15 affected50 at risk
Type I hypersensitivity	Immune system disorders	MedDRA V16.0	Systematic Assessment	EG0001,047 events75 affected96 at risk EG001152 events31 affected50 at risk
Bronchitis	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0014 events3 affected50 at risk
Croup infectious	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00027 events14 affected96 at risk EG0017 events5 affected50 at risk
Ear infection	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00014 events12 affected96 at risk EG0018 events7 affected50 at risk
Gastroenteritis	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00048 events35 affected96 at risk EG00119 events12 affected50 at risk
Gastroenteritis viral	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00027 events19 affected96 at risk EG0019 events9 affected50 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0006 events6 affected96 at risk EG0012 events2 affected50 at risk
Impetigo	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0005 events5 affected96 at risk EG0010 events0 affected50 at risk
Influenza	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0009 events8 affected96 at risk EG0017 events7 affected50 at risk
Molluscum contagiosum	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0005 events5 affected96 at risk EG0013 events3 affected50 at risk
Nasopharyngitis	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00013 events8 affected96 at risk EG0018 events2 affected50 at risk
Otitis media	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00038 events23 affected96 at risk EG00121 events15 affected50 at risk
Otitis media acute	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0005 events5 affected96 at risk EG0012 events2 affected50 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00028 events21 affected96 at risk EG0018 events3 affected50 at risk
Pneumonia	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00010 events9 affected96 at risk EG0016 events5 affected50 at risk
Respiratory tract infection	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0014 events4 affected50 at risk
Sinusitis	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00019 events13 affected96 at risk EG00116 events5 affected50 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00073 events34 affected96 at risk EG00142 events18 affected50 at risk
Urinary tract infection	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0014 events4 affected50 at risk
Viral infection	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00067 events33 affected96 at risk EG00116 events12 affected50 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA V16.0	Systematic Assessment	EG00042 events26 affected96 at risk EG00114 events8 affected50 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA V16.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0013 events3 affected50 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA V16.0	Systematic Assessment	EG0006 events5 affected96 at risk EG0012 events2 affected50 at risk
Headache	Nervous system disorders	MedDRA V16.0	Systematic Assessment	EG00011 events8 affected96 at risk EG0011 events1 affected50 at risk
Agitation	Psychiatric disorders	MedDRA V16.0	Systematic Assessment	EG00010 events9 affected96 at risk EG0013 events3 affected50 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA V16.0	Systematic Assessment	EG00017 events12 affected96 at risk EG00111 events8 affected50 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA V16.0	Systematic Assessment	EG000133 events48 affected96 at risk EG00149 events23 affected50 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA V16.0	Systematic Assessment	EG00039 events22 affected96 at risk EG00118 events9 affected50 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA V16.0	Systematic Assessment	EG00033 events20 affected96 at risk EG00117 events6 affected50 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA V16.0	Systematic Assessment	EG00016 events9 affected96 at risk EG0012 events2 affected50 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA V16.0	Systematic Assessment	EG0009 events7 affected96 at risk EG0010 events0 affected50 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA V16.0	Systematic Assessment	EG00033 events17 affected96 at risk EG00122 events15 affected50 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA V16.0	Systematic Assessment	EG00013 events9 affected96 at risk EG0018 events7 affected50 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA V16.0	Systematic Assessment	EG00065 events27 affected96 at risk EG00116 events12 affected50 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA V16.0	Systematic Assessment	EG0008 events5 affected96 at risk EG0015 events5 affected50 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA V16.0	Systematic Assessment	EG00039 events15 affected96 at risk EG00117 events10 affected50 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA V16.0	Systematic Assessment	EG00033 events24 affected96 at risk EG00124 events11 affected50 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA V16.0	Systematic Assessment	EG0009 events7 affected96 at risk EG0011 events1 affected50 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA V16.0	Systematic Assessment	EG00065 events24 affected96 at risk EG00129 events16 affected50 at risk

ID	Term
D021183	Peanut Hypersensitivity
D006967	Hypersensitivity

ID	Term
D000074924	Nut and Peanut Hypersensitivity
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate
D007154	Immune System Diseases