NCT03682770|CompletedPhase 2ResultsDMCFDA Drug

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

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)

Regeneron Pharmaceuticals ClinicalTrials.gov

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1 other identifier

R668-ALG-16114

Study Type

interventional

Target

148

Locations

1 country

Sites

Timeline

RegisteredSep 2018

StartedOct 2018

CompletionJul 2021

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

148

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2018

Typical duration for phase_2

Geographic Reach

1 country

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

September 21, 2018

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed

8 days until next milestone

Study Start

First participant enrolled

October 3, 2018

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2021

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

February 7, 2024

Completed

Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

September 21, 2018

Results QC Date

October 13, 2023

Last Update Submit

January 12, 2024

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 Who Passed a Post Up-dosing Double-blind, Placebo-controlled Food Challenge (DBPCFC) With 2044 mg (Cumulative) Peanut Protein at Visit 16 (Week 28 to 40)
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The allergic reaction is measured on a 1-5 scale, with grade 1 being mild, grade 2 being moderate, grade 3 being severe, grade 4 being life threatening, and grade 5 as death. the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab plus AR101 vs placebo plus AR101 who passed a post up-dosing DBPCFC with 2044 mg (Cumulative) peanut protein at Visit 16 (Week 28 to 40) was reported. Cumulative data during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 28 to Week 40).
At Visit 16 (Week 28 to 40)

Secondary Outcomes (10)

Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Visit 16 (Week 28 to 40) in Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101
Baseline, Visit 16 (Week 28 to 40)
Percentage of Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 Who Reached the 300 mg/Day Dose of AR101 by Visit 16 (Week 28 to 40)
At Visit 16 (Week 28 to 40)
Time From Randomization to the First Time When Participants Reached the 300 mg/Day Dose of AR101 During the Up-dosing Treatment Phase by Visit 16 (Week 28 to 40)
At Visit 16 (Week 28 to 40)
Percentage of Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 Who Passed a Post Maintenance DBPCFC With 2044 mg (Cumulative) Peanut Protein at Visit 22 (Week 52 to 64)
At Visit 22 (Week 52 to 64)
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Visit 22 (Week 52 to 64) in Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101
Baseline, Visit 22 (Week 52 to 64)
+5 more secondary outcomes

Study Arms (2)

dupilumab + AR101

EXPERIMENTAL

Participant randomization of a ratio of 2 active dupilumab arms

Drug: DupilumabDrug: AR101

placebo matching dupilumab + AR101

EXPERIMENTAL

Participant randomization of a ratio of 1 placebo arm

Drug: Placebo matching dupilumabDrug: AR101

Interventions

DupilumabDRUG

Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)

dupilumab + AR101

Placebo matching dupilumabDRUG

Placebo matching dupilumab is prepared in the same formulation without the addition of protein

placebo matching dupilumab + AR101

AR101DRUG

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

dupilumab + AR101placebo matching dupilumab + AR101

Eligibility Criteria

Age6 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.