Efficacy of Tezepelumab in Peanut Oral Immunotherapy (NCT07015996)
Efficacy of Tezepelumab in Peanut Oral Immunotherapy: a Double-Blind, Randomized, Placebo-Controlled Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology — Little Rock, Arkansas
Age range: 12 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology — Little Rock, Arkansas
- University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy — Los Angeles, California
- Johns Hopkins Children's Center: Department of Allergy & Immunology — Baltimore, Maryland
- Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit — Boston, Massachusetts
- Boston Children's Hospital: Allergy and Asthma Program — Boston, Massachusetts
- The University of Michigan: Division of Allergy and Clinical Immunology — Ann Arbor, Michigan
- Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology — New York, New York
- North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology — Chapel Hill, North Carolina
- Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology — Cincinnati, Ohio
- University of Texas Southwestern Medical Center: Division of Allergy and Immunology — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (501) 364-2325
Email: ThomasES@archildrens.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Peanut Allergy
- Food Oral Immunotherapy for Peanut Allergy — Boston, Massachusetts
- A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy — Little Rock, Arkansas
- Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects — Tucson, Arizona
- Peanut and Tree Nut Desensitization — Toronto, Ontario
- Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy — Montreal, Quebec
- Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety — Montreal, Quebec
Explore by condition: All Peanut Allergy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.