62
Participants
Start Date
September 16, 2025
Primary Completion Date
September 16, 2028
Study Completion Date
September 16, 2028
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."
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."
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."
Johns Hopkins Children's Center: Department of Allergy & Immunology, Baltimore
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, Chapel Hill
Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology, Cincinnati
The University of Michigan: Division of Allergy and Clinical Immunology, Ann Arbor
Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology, Little Rock
University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy, Los Angeles
Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit, Boston
Boston Children's Hospital: Allergy and Asthma Program, Boston
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology, New York
University of Texas Southwestern Medical Center: Division of Allergy and Immunology, Dallas
Collaborators (1)
Immune Tolerance Network (ITN)
NETWORK
PPD Development, LP
INDUSTRY
Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH