Condition: Peanut Allergy · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
Always discuss trial participation with your own doctor first.
| Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology | Little Rock, Arkansas, United States | Not Yet Recruiting |
| University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy | Los Angeles, California, United States | Not Yet Recruiting |
| Johns Hopkins Children's Center: Department of Allergy & Immunology | Baltimore, Maryland, United States | Not Yet Recruiting |
| Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit | Boston, Massachusetts, United States | Not Yet Recruiting |
| Boston Children's Hospital: Allergy and Asthma Program | Boston, Massachusetts, United States | Not Yet Recruiting |
| The University of Michigan: Division of Allergy and Clinical Immunology | Ann Arbor, Michigan, United States | Not Yet Recruiting |
| Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology | New York, New York, United States | Not Yet Recruiting |
| North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology | Chapel Hill, North Carolina, United States | Recruiting |
| Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology | Cincinnati, Ohio, United States | Recruiting |
| University of Texas Southwestern Medical Center: Division of Allergy and Immunology | Dallas, Texas, United States | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07015996