The proposed study is a proof-of-concept Phase 2, double-blind, randomized placebo-controlled clinical trial evaluating the safety and efficacy of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy. Study participation is divided into 3 periods: (i) a monotherapy period comprised of injections of either Tezepelumab or placebo from week 0 to week 8, (ii) followed by a combination therapy period comprised of 56 weeks during which peanut OIT is built up and maintained, and (iii) a treatment withdrawal period comprised of 12 weeks. This study will enroll 62 peanut-allergic individuals from 12 to 55 years of age who experience dose-limiting symptoms to \<=100 mg of peanut protein in a single dose (\<= 144 mg cumulative dose) as assessed by DBPCFC. The primary objective is to determine whether 56 weeks of tezepelumab plus peanut OIT as compared to 56 weeks of placebo plus peanut OIT induces sustained unresponsiveness to peanut 12 weeks after stopping combination therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Monotherapy Period: Participants randomized to tezepelumab will receive two subcutaneous (SQ) injections of tezepelumab 210 mg during the monotherapy period. Combination Therapy Period: Participants randomized to Tezepelumab will continue to receive Tezepelumab 210 mg every 4 weeks. Withdrawal Period: Participants will stop receiving Tezepelumab injections.
Monotherapy Period: Not Applicable. Combination Therapy Period: During combination therapy period, each participant will start peanut OIT. Participants will start on a minimum of 0.1 mg peanut OIT, with starting dose depending on last tolerated dose from screening double-blind placebo-controlled food challenge (DBPCFC) and build to a maximum of 6 mg peanut OIT on the initial dose escalation (IDE) day. Participants will return every 2 weeks for dose escalation to a goal maintenance dose of 2000 mg peanut protein. Withdrawal Period: Participants will stop peanut OIT.
Monotherapy Period: Participants randomized to placebo for tezepelumab will receive two subcutaneous (SQ) injections of placebo 210 mg during the monotherapy period. Combination Therapy Period: Participants randomized to placebo will continue to receive placebo for Tezepelumab every 4 weeks. Withdrawal Period: Participants will stop receiving placebo injections.
Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
Little Rock, Arkansas, United States
University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy
Los Angeles, California, United States
Johns Hopkins Children's Center: Department of Allergy & Immunology
Baltimore, Maryland, United States
Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit
Boston, Massachusetts, United States
Boston Children's Hospital: Allergy and Asthma Program
Boston, Massachusetts, United States
The University of Michigan: Division of Allergy and Clinical Immunology
Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
New York, New York, United States
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology
Cincinnati, Ohio, United States
University of Texas Southwestern Medical Center: Division of Allergy and Immunology
Dallas, Texas, United States
Consumption of a cumulative dose of 4000 mg of peanut protein without dose-limiting symptoms during the open Oral Food Challenge (OFC)
The primary endpoint is sustained unresponsiveness to peanut 12 weeks after stopping combination therapy, as assessed by passing the open OFC to peanut at Week 76
Time frame: At week 76
Highest single dose of peanut protein consumed without doselimiting symptoms during the open Oral Food Challenge (OFC)
Time frame: At week 64 and 76
Consumption of a cumulative dose of 4000 mg of peanut protein without doselimiting symptoms during the open Oral Food Challenge (OFC)
Time frame: At week 64
Highest cumulative dose of peanut protein consumed without dose limiting symptoms during the open Oral Food Challenge (OFC)
Time frame: At week 64 and 76
An adverse event related to monotherapy
Time frame: During 8 weeks of therapy
An adverse event related to combination therapy
Time frame: During 56 weeks of therapy
An adverse event related to tezepelumab plus peanut Oral Immunotherapy (OIT) discontinuation
Time frame: 12 weeks after discontinuation of treatment
An adverse event related to placebo plus peanut Oral Immunotherapy (OIT) discontinuation
Time frame: 12 weeks after discontinuation of treatment
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