ClinicalTrials.gov
ClinicalTrials.gov Menu

Study in Pediatric Subjects With Peanut Allergy to Evaluate the 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03682770
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : January 7, 2019
Sponsor:
Collaborators:
Sanofi
Aimmune Therapeutics, Inc.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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 double-blind placebo-controlled food challenge (DBPCFC) at week 28.

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 DBPCFC at week 28
  • 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 DBPCFC at week 52
  • 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 DBPCFC at week 52
  • 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 G4 (IgG4), and peanut-specific IgG4/IgE ratio
  • To assess if dupilumab increases the tolerability of AR101 as measured by the daily symptoms (e-diary) during the up-dosing phase

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: Dupilumab Drug: Placebo matching dupilumab Drug: AR101 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : March 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: dupilumab + AR101
Participant randomization of 2 active dupilumab arm:1 placebo for dupilumab arm
Drug: Dupilumab
Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)

Drug: AR101
AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase

Experimental: placebo matching dupilumab + AR101 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




Primary Outcome Measures :
  1. Proportion of participants treated with dupilumab plus AR101 vs placebo plus AR101 who "pass" a double-blind, placebo-controlled food challenge (DBPCFC) with (cumulative) peanut protein [ Time Frame: At Week 28 ]

Secondary Outcome Measures :
  1. 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: Baseline to Week 28 ]
  2. Proportion of participants treated with dupilumab plus AR101 vs placebo plus AR101 who reach the dose of AR101 [ Time Frame: Up to Week 28 ]
  3. Time from randomization to the first time when participants reach the dose of AR101 [ Time Frame: Baseline to Week 28 ]
  4. Proportion of participants (continuously) treated with dupilumab plus AR101 vs placebo plus AR101 who "pass" a DBPCFC with (cumulative) peanut protein [ Time Frame: At Week 52 ]
  5. 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: Baseline to Week 52 ]
  6. Proportion of participants (previously) treated with dupilumab plus AR101 (and re-randomized to placebo plus AR101) vs placebo plus AR101 who "pass" a DBPCFC with (cumulative) peanut protein [ Time Frame: At Week 52 ]
  7. 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: Baseline to Week 52 ]
  8. Percent change in peanut-specific Immunoglobulin E (IgE) in participants treated with dupilumab plus AR101 vs participants treated with placebo plus AR101 [ Time Frame: Baseline to Week 28 ]
  9. Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101 vs participants treated with placebo plus AR101 [ Time Frame: Baseline to Week 52 ]
  10. Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101 vs participants treated with placebo plus AR101 [ Time Frame: Baseline to Week 64 ]
  11. Proportion of participants experiencing symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline to Week 28 ]
  12. 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 ]
  13. Difference in mean/median duration of symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline to Week 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Serum Immunoglobulin E (IgE) to peanut of ≥24 kUA/L and/or a skin prick test (SPT) to peanut ≥10 mm compared to a negative control
  • Participants/caregivers 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 investigation form 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682770


Contacts
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
United States, Alabama
Regeneron Investigational Site Recruiting
Birmingham, Alabama, United States, 35209
United States, California
Regeneron Investigational Site Recruiting
Mission Viejo, California, United States, 92691
Regeneron Investigational Site Recruiting
Rolling Hills Estates, California, United States, 90274
United States, Florida
Regeneron Investigational Site Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Regeneron Investigational Site Recruiting
Marietta, Georgia, United States, 30144
United States, Michigan
Regeneron Investigational Site Recruiting
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Regeneron Investigational Site Recruiting
Minneapolis, Minnesota, United States, 55402
United States, New Jersey
Regeneron Investigational Site Recruiting
Ocean Township, New Jersey, United States, 07712
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Aimmune Therapeutics, Inc.
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03682770     History of Changes
Other Study ID Numbers: R668-ALG-16114
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs