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Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682770
Recruitment Status : Active, not recruiting
First Posted : September 25, 2018
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
Sanofi
Aimmune Therapeutics, Inc.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 21, 2018
First Posted Date  ICMJE September 25, 2018
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE October 3, 2018
Estimated Primary Completion Date December 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
Proportion of participants treated with dupilumab plus AR101 vs placebo plus AR101 who "pass" a post up-dosing double-blind, placebo-controlled food challenge (DBPCFC) with 2044 mg (cumulative) peanut protein [ Time Frame: Up to 40 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
Proportion of participants treated with dupilumab plus AR101-CODIT vs placebo plus AR101-CODIT who "pass" a double-blind, placebo-controlled food challenge (DBPCFC) with (cumulative) peanut protein [ Time Frame: At Week 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
  • Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants treated with dupilumab plus AR101 vs placebo plus AR101 [ Time Frame: Up to 40 weeks ]
  • Proportion of participants treated with dupilumab plus AR101 vs placebo plus AR101 who reach the dose of AR101 [ Time Frame: Up to 40 weeks ]
  • Time from randomization to the first time when participants reach the dose of AR101 [ Time Frame: Up to 40 weeks ]
  • Proportion of participants (continuously) treated with dupilumab plus AR101 vs placebo plus AR101 who "pass" a post maintenance DBPCFC with 2044 mg (cumulative) peanut protein [ Time Frame: Up to 64 weeks ]
  • Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants (continuously) treated with dupilumab plus AR101 vs placebo plus AR101 [ Time Frame: Up to 64 weeks ]
  • Proportion of participants (previously) treated with dupilumab plus AR101 (and re-randomized to placebo plus AR101) vs placebo plus AR101 who "pass" a post maintenance DBPCFC with 2044 mg (cumulative) peanut protein [ Time Frame: Up to 64 weeks ]
  • Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants (previously) treated with dupilumab plus AR101 (and re-randomized to placebo plus AR101) vs placebo plus AR101 [ Time Frame: Up to 64 weeks ]
  • Percent change in peanut-specific Immunoglobulin E (IgE) in participants treated with dupilumab plus AR101 vs participants treated placebo plus AR101 [ Time Frame: Up to 40 weeks ]
  • Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101 vs participants treated placebo plus AR101 [ Time Frame: Up to 64 weeks ]
  • Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101 vs participants treated placebo plus AR101 [ Time Frame: Up to 76 weeks ]
  • Proportion of participants experiencing symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline up to 40 weeks ]
  • Proportion of participants experiencing mild, moderate, or severe symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline up to 40 weeks ]
  • Difference in mean/median duration of symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline up to 40 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants treated with dupilumab plus AR101-CODIT vs placebo plus AR101-CODIT [ Time Frame: Baseline to Week 28 ]
  • Proportion of participants treated with dupilumab plus AR101-CODIT vs placebo plus AR101-CODIT who reach the dose of AR101-CODIT [ Time Frame: Up to Week 28 ]
  • Time from randomization to the first time when participants reach the dose of AR101-CODIT [ Time Frame: Baseline to Week 28 ]
  • Proportion of participants (continuously) treated with dupilumab plus AR101-CODIT vs placebo plus AR101-CODIT who "pass" a DBPCFC with (cumulative) peanut protein [ Time Frame: At Week 52 ]
  • Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants (continuously) treated with dupilumab plus AR101-CODIT vs placebo plus AR101-CODIT [ Time Frame: Baseline to Week 52 ]
  • Proportion of participants (previously) treated with dupilumab plus AR101-CODIT (and re-randomized to placebo plus AR101-CODIT) vs placebo plus AR101-CODIT who "pass" a DBPCFC with (cumulative) peanut protein [ Time Frame: At Week 52 ]
  • Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants (previously) treated with dupilumab plus AR101-CODIT (and re-randomized to placebo plus AR101-CODIT) vs placebo plus AR101-CODIT [ Time Frame: Baseline to Week 52 ]
  • Percent change in peanut-specific Immunoglobulin E (IgE) in participants treated with dupilumab plus AR101-CODIT vs participants treated with placebo plus AR101-CODIT [ Time Frame: Baseline to Week 28 ]
  • Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101-CODIT vs participants treated with placebo plus AR101-CODIT [ Time Frame: Baseline to Week 52 ]
  • Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101-CODIT vs participants treated with placebo plus AR101-CODIT [ Time Frame: Baseline to Week 64 ]
  • Proportion of participants experiencing symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline to Week 28 ]
  • Proportion of participants experiencing mild, moderate, or severe symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline to Week 28 ]
  • Difference in mean/median duration of symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline to Week 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Official Title  ICMJE A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Brief Summary

Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing double-blind placebo-controlled food challenge (DBPCFC) at visit 16.

Secondary objectives are:

  • To assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a post up-dosing DBPCFC at visit 16
  • To assess whether dupilumab as (indefinite [continuously]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22
  • To assess whether dupilumab as (limited [previously]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22
  • To evaluate the safety and tolerability of dupilumab as adjunct to AR101 compared to placebo
  • To assess the effect of dupilumab (compared to placebo) as adjunct to AR101 on the change in peanut-specific Immunoglobulin E (sIgE), Immunoglobulin G (IgG), Immunoglobulin G4 (IgG4), and peanut-specific IgG4/IgE ratio
  • To assess if dupilumab increases the tolerability of AR101 as measured by the daily symptoms (electronic diary [e-diary]) during the up-dosing phase
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE
  • Drug: Dupilumab
    Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)
  • Drug: Placebo matching dupilumab
    Placebo matching dupilumab is prepared in the same formulation without the addition of protein
  • Drug: AR101
    AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase
Study Arms  ICMJE
  • Experimental: dupilumab + AR101
    Participant randomization of a ratio of 2 active dupilumab arms
    Interventions:
    • Drug: Dupilumab
    • Drug: AR101
  • Experimental: placebo matching dupilumab + AR101
    Participant randomization of a ratio of 1 placebo arm
    Interventions:
    • Drug: Placebo matching dupilumab
    • Drug: AR101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2018)
156
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Experience dose-limiting symptoms at or before the challenge dose of peanut protein on screening and not experiencing dose-limiting symptoms to placebo as defined in the protocol
  • Serum Immunoglobulin E (IgE) to peanut of ≥10 kUA/L and/or a skin prick test (SPT) to peanut ≥8 mm compared to a negative control
  • Participants/legal guardians must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study
  • Participants with other known 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

Key Exclusion Criteria:

  • History of other chronic disease (other than asthma, Atopic Dermatitis (AD), or allergic rhinitis) requiring therapy (eg, heart disease, diabetes, hypertension) that would represent a risk to participant's health or safety in this study or ability to comply with study protocol
  • History of frequent or recent severe, life-threatening episode of anaphylaxis or anaphylactic shock
  • History of eosinophilic Gastrointestinal (GI) disease
  • Asthma at time of enrollment with any of the following:

    • Forced Expiratory Volume 1 Second (FEV1) <80% of predicted or ratio of FEV1 to forced vital capacity (FEV1/FVC) <75% of predicted with or without controller medications
    • Inhaled corticosteroids (ICS) dosing of daily fluticasone (or equivalent ICS based on NHLBI dosing chart)
    • One hospitalization in the past year for asthma
    • Emergency room visit for asthma within 6 months prior to screening
  • Use of systemic corticosteroids within 2 months prior to screening
  • Use of other forms of allergen immunotherapy or immunomodulatory therapy within 3 months prior to screening
  • Use of any agents known or likely to interact with epinephrine (eg, beta-blockers, angiotensin converting enzyme-inhibitors, tri-cyclic antidepressants, or other drugs), within 3 weeks prior to screening
  • Allergy to oat (placebo in DBPCFC)

Note: Other protocol Inclusion/Exclusion Criteria apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03682770
Other Study ID Numbers  ICMJE R668-ALG-16114
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE
  • Sanofi
  • Aimmune Therapeutics, Inc.
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP