Peanut Oral Immunotherapy in Children (IMPACT)
|ClinicalTrials.gov Identifier: NCT01867671|
Recruitment Status : Active, not recruiting
First Posted : June 4, 2013
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peanut Hypersensitivity||Biological: Peanut Oral Immunotherapy - Liquid Extract Biological: Placebo for Peanut Oral Immunotherapy - Liquid Extract form Biological: Peanut Oral Immunotherapy - Peanut Flour Biological: Placebo for Peanut Oral Immunotherapy - Peanut Flour||Phase 2|
An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases:
- Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given.
- Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation.
- Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein).
- Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)|
|Actual Study Start Date :||August 13, 2013|
|Estimated Primary Completion Date :||May 21, 2018|
|Estimated Study Completion Date :||December 3, 2018|
Experimental: Peanut Oral Immune Therapy (OIT)
Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.
Biological: Peanut Oral Immunotherapy - Liquid Extract
Used during initial dose escalation for doses 0.1 to 0.8 mg.Biological: Peanut Oral Immunotherapy - Peanut Flour
This will be used for the remainder of dose escalation, build-up, and maintenance.
Placebo Comparator: Peanut Placebo
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
Similar in appearance, texture, and taste to peanut liquid extract.Biological: Placebo for Peanut Oral Immunotherapy - Peanut Flour
Similar in appearance, texture, and taste to peanut flour.
- Proportion of Desensitized Subjects [ Time Frame: week 134 ]Participants who pass an oral food challenge (OFC) to 10 g of peanut flour (5 g of peanut protein) at this time without significant symptoms will be considered desensitized to peanut. Failure will be defined as either unable to undergo the final food challenge or inability to tolerate the maximum dose because of significant symptoms such as hives, wheezing, vomiting, or laryngeal edema.
- Tolerance Endpoint [ Time Frame: week 160 ]The proportion of participants who pass the OFC to 10 g peanut flour (5 g peanut protein).
- Transient Desensitization [ Time Frame: week 134 to week 160 ]The change in proportion of participants who pass the OFC to 10 g peanut flour (5 g peanut protein)at week 134 and week 160.
- Highest Tolerated Cumulative Dose [ Time Frame: week 160 ]The highest tolerated cumulative dose of peanut protein during the OFCs.
- The incidence of all adverse events [ Time Frame: week 160 ]
- Rates of Withdrawal from OIT or Placebo [ Time Frame: week 160 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867671
|United States, Arkansas|
|University of Arkansas for Medical Sciences: Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72202|
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94040|
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Study Chair:||Wesley Burks, MD||UNC Chapel-Hill|
|Study Chair:||Stacie M. Jones, MD||University of Arkansas|