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NCT07611435 · ClinicalTrials.gov registry record · Phase 2
Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13) - BeACON4AG
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Not yet
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT07611435: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07611435 is a Phase 2 study that has not yet begun recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07611435, a Phase 2 study, has not yet begun recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
This is a multisite, randomized, double-blind, controlled cross-over trial with detailed characterization of participants with varying clinical sub-phenotypes of Alpha-gal Syndrome (AGS) who are then evaluated by oral food challenges with alpha-gal Knock Out (KO) pork versus Wild Type (WT) pork. Each participant will serve as their own control and ingest both alpha-gal-KO and WT pork on different days, with a minimum of an 8-day washout period between oral food challenges. The primary objective is to determine whether the odds of positive challenges among participants with suspected alpha-gal syndrome are lower with alpha-gal Knock Out (KO) pork as compared to Wild Type (WT) pork during Double Blind Food Challenge (DBFC)
Primary Outcome
A positive challenge will be defined as experiencing symptoms grade 2 or higher on the Consortium for Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions (scale range from 1 to 5, with higher scores indicating a more severe reaction) within 6 hours of ingestion.
Interventions
- DIAGNOSTIC_TEST DBFC with 150g of Alpha-gal Knock Out (KO) pork
- DIAGNOSTIC_TEST DBFC with 150g of Wild Type (WT) pork
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2026-07-30 |
| Est. Completion | 2032-09-30 |
| Phase | Phase 2 |
What is known before NCT07611435 opens enrollment
NCT07611435 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which DBFC with 150g of Alpha-gal Knock Out (KO) pork is the first listed.
NCT07611435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07611435 about?
NCT07611435 is a clinical study titled "Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13) - BeACON4AG". This is a multisite, randomized, double-blind, controlled cross-over trial with detailed characterization of participants with varying clinical sub-phenotypes of Alpha-gal Syndrome (AGS) who are then evaluated by oral food challenges with alpha-gal Knock Out (KO) pork versus Wild Type (WT) pork. Eac...
What is the current status of trial NCT07611435?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2026-07-30. Estimated completion is 2032-09-30.
What interventions are being tested in trial NCT07611435?
The interventions under investigation include: DBFC with 150g of Alpha-gal Knock Out (KO) pork (DIAGNOSTIC_TEST), DBFC with 150g of Wild Type (WT) pork (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07611435?
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 NCT07611435's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 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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