Efficacy of Tezepelumab in Peanut Oral Immunotherapy

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

September 16, 2025

Primary Completion Date

September 16, 2028

Study Completion Date

September 16, 2028

Conditions
Peanut Allergy
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."

Trial Locations (10)

21287

Johns Hopkins Children's Center: Department of Allergy & Immunology, Baltimore

27599

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, Chapel Hill

45229

Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology, Cincinnati

48105

The University of Michigan: Division of Allergy and Clinical Immunology, Ann Arbor

72202

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology, Little Rock

90095

University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy, Los Angeles

02114

Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit, Boston

02115

Boston Children's Hospital: Allergy and Asthma Program, Boston

10029-6574

Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology, New York

75390-9063

University of Texas Southwestern Medical Center: Division of Allergy and Immunology, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

collaborator

PPD Development, LP

INDUSTRY

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH