Efficacy of Tezepelumab in Peanut Oral Immunotherapy
Public ClinicalTrials.gov record NCT07015996. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy of Tezepelumab in Peanut Oral Immunotherapy: a Double-Blind, Randomized, Placebo-Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07015996
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 62 participants
Conditions and interventions
Conditions
Interventions
- Tezepelumab Biological
- Peanut Oral Immunotherapy (OIT) Drug
- Placebo for Tezepelumab Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 12 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 14, 2026
- Primary completion
- Sep 15, 2028
- Completion
- Sep 15, 2028
- Last update posted
- Jun 25, 2026
2026 – 2028
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology | Little Rock | Arkansas | 72202 | Not yet recruiting |
| University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy | Los Angeles | California | 90095 | Not yet recruiting |
| Johns Hopkins Children's Center: Department of Allergy & Immunology | Baltimore | Maryland | 21287 | Not yet recruiting |
| Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit | Boston | Massachusetts | 02114 | Not yet recruiting |
| Boston Children's Hospital: Allergy and Asthma Program | Boston | Massachusetts | 02115 | Not yet recruiting |
| The University of Michigan: Division of Allergy and Clinical Immunology | Ann Arbor | Michigan | 48105 | Not yet recruiting |
| Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology | New York | New York | 10029-6574 | Not yet recruiting |
| North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology | Chapel Hill | North Carolina | 27599 | Recruiting |
| Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology | Cincinnati | Ohio | 45229 | Recruiting |
| University of Texas Southwestern Medical Center: Division of Allergy and Immunology | Dallas | Texas | 75390-9063 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07015996, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 25, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07015996 live on ClinicalTrials.gov.