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Completed

NCT Number: NCT02198664

Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study

This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.

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Key information

Conditions

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

Age range

4 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

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About this study

This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows:

  • Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001
  • Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001

All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA).

Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Completion of ARC001 study
  • No change in the status of any longitudinally applicable ARC001 inclusion criteria

Key Exclusion Criteria:

  • Early termination from ARC001
  • Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
  • A lapse in dosing of more than 10 days from completion of ARC001
  • Change in the status of any longitudinally applicable ARC001 exclusion criteria

Treatment and study plan

AR101 - Peanut protein capsule

Biological

Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Primary outcomes

  1. Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months

    Time frame: Up to 90 weeks

    TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).

Secondary outcomes

  1. The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC

    Time frame: Up to 36 weeks

  2. The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.

    Time frame: Up to 60 weeks.

  3. Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein

    Time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)

    The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.

  4. Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated

    Time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)

    The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs

  5. Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance

    Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

  6. Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance

    Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

  7. Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance

    Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

  8. Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC

    Time frame: Up to 36 weeks for up-dosing

    Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC

  9. Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC

    Time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)

    Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC

  10. Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.

    Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

    A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.

Sponsors and collaborators

Lead sponsor

Aimmune Therapeutics, Inc.

Industry

Registry information

Official study title

Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2014
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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