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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07015996
The ClinicalTrials.gov registry entry for NCT07015996 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Tezepelumab is the first listed.
NCT07015996 reports 0 study locations.
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.
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