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Can a new injection tame wheat allergy?

NCT ID NCT07816432

Disease control Sponsor: Longbio Pharma (Suzhou) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing an experimental injectable drug called LP-003 in people with wheat allergy that triggers allergic reactions during exercise. The Phase II trial enrolls 12 participants aged 12 to 60 who have a history of wheat or gluten allergy and react to a small amount of gluten during a food-exercise challenge. The study measures whether participants can eat a larger amount of gluten without symptoms and tracks safety, how the drug moves through the body, and immune responses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental injectable biologic called LP-003
What this could lead to
If it works, LP-003 could become a treatment that helps people with wheat allergy tolerate accidental gluten exposure, especially during exercise.
What could go wrong
This is a small Phase II trial with only 12 participants, so results may not apply broadly. The drug is experimental, and its safety and effectiveness in larger groups are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged ≥12 years and ≤60 years, male or female; * History of wheat or gluten allergy; * Positive skin prick test (SPT) to the allergen (wheat or gluten), and/or positive allergen-specific immunoglobulin E (sIgE) to food allergen (crude wheat/gluten extract or ω 5 gliadin) at screening or within three months prior to screening; * Dose-limiting symptoms occurred at a cumulative dose of ≤24 g gluten protein during the food-exercise challenge test at screening; * No plan to conceive and agree to use effective contraceptive measures throughout the trial period; * The participant and/or parent/legal representative understands and voluntarily signs the informed consent form. Exclusion Criteria: * Allergic to LP-003 Injection or its excipients; * Uncontrolled asthma or severe asthma at screening; * Any severe disease; * History of severe allergic reactions to wheat or gluten; * Not enough washing-out period for previous therapy before the food exercise challenge at screening.

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Conditions

The condition(s) this trial relates to.

food allergy food-dependent exercise-induced anaphylaxis Wheat Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Food allergy Wheat hypersensitivity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, China

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