Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
| Status: | Recruiting |
|---|---|
| Conditions: | Allergy, Allergy, Neurology |
| Therapuetic Areas: | Neurology, Otolaryngology |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 1/9/2019 |
| Start Date: | October 3, 2018 |
| End Date: | March 9, 2021 |
| Contact: | Clinical Trials Administrator |
| Email: | clinicaltrials@regeneron.com |
| Phone: | 844-734-6643 |
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)
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
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
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
We found this trial at
8
sites
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