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NOT YET RECRUITING
NCT07015996
PHASE2

Efficacy of Tezepelumab in Peanut Oral Immunotherapy

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy of Tezepelumab in Peanut Oral Immunotherapy: a Double-Blind, Randomized, Placebo-Controlled Trial

Key Details

Gender

All

Age Range

12 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2026-02-18

Completion Date

2028-09-16

Last Updated

2025-10-30

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Tezepelumab

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.

DRUG

Peanut Oral Immunotherapy (OIT)

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.

BIOLOGICAL

Placebo for Tezepelumab

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.

Locations (10)

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