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NCT07015996 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT07015996: Recruiting Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07015996 is a Phase 2 study that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07015996, a Phase 2 study, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary endpoint is sustained unresponsiveness to peanut 12 weeks after stopping combination therapy, as assessed by passing the open OFC to peanut at Week 76
Interventions
- BIOLOGICAL Tezepelumab
- DRUG Peanut Oral Immunotherapy (OIT)
- BIOLOGICAL Placebo for Tezepelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2028-09-16 |
| Phase | Phase 2 |
What NCT07015996 shows while recruiting
NCT07015996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Tezepelumab is the first listed.
NCT07015996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07015996 about?
NCT07015996 is a clinical study titled "Efficacy of Tezepelumab in Peanut Oral Immunotherapy". 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 per...
What is the current status of trial NCT07015996?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2026-07-15. Estimated completion is 2028-09-16.
What interventions are being tested in trial NCT07015996?
The interventions under investigation include: Tezepelumab (BIOLOGICAL), Peanut Oral Immunotherapy (OIT) (DRUG), Placebo for Tezepelumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07015996?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07015996's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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