New antibody aims to neutralize allergies by clearing IgE

NCT ID NCT07701954

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental antibody drug called LCA-0061, designed to target and remove immunoglobulin E (IgE), a key driver of allergic reactions. The study first evaluates safety and tolerability in healthy people with elevated IgE levels, then in people with peanut allergy. Researchers are looking at how the drug moves through the body and whether it triggers an immune response.

What this could mean

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

Active substance
an antibody-based drug called LCA-0061 that targets and clears immunoglobulin E (IgE)
What this could lead to
If successful, this could lead to a new treatment for peanut allergy and other allergic conditions by lowering IgE levels.
What could go wrong
This is an early Phase 1 trial focused on safety, so it is too soon to know if the drug will effectively treat allergies. Side effects are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 72 people

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

Started

Jun 2026

Expected to finish

Apr 2028

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

18 to 55 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.

Key Inclusion Criteria: Part A (SAD) and Part B (MAD) 1. Must provide written consent for participation 2. Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 (inclusive) and body weight ≥ 50kg at screening 3. Have elevated serum IgE at screening 4. Female participants of childbearing potential or male participants capable of fathering a child must be willing to use highly effective methods of contraception throughout the study and for at least 30 days after the last dose of the investigational product. Part A Only 1.Must be otherwise healthy with history of atopy defined as one or more of the following: history of positive skin tests to common allergens, allergic conjunctivitis, food allergy, atopic dermatitis, urticaria Part B Only 1. Be otherwise healthy with history of peanut allergy 2. Elevated peanut-specific serum IgE within 6 months of screening 3. Have positive skin prick test (SPT) to peanuts at screening Key Exclusion Criteria: Part A and B 1. Pregnant or lactating 2. History of clinically relevant underlying comorbidities including: 1. chronic obstructive pulmonary disease 2. myocardial infarction 3. chronic heart failure or unstable angina pectoris 4. hyperlipidemia 5. liver disease or known hepatic or biliary abnormalities \[except Gilbert's disease or asymptomatic gallstones\] 6. autoimmune or connective tissue disease 7. chronic inflammatory disease 8. persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals 9. poorly controlled atopic dermatitis requiring treatment with phototherapy, systemic immunosuppressants, or immunomodulators 10. Poorly controlled asthma 11. poorly controlled hypertension 3. clinically significant abnormal electrocardiogram or laboratory tests (hematology, clinical chemistries, liver function tests, lipid panel, serology, or urinalysis) at screening 4. Currently receiving immunotherapy for food allergies 5. Use of nicotine containing products (excluding nicotine patches or gum for smoking cessation) within 6 months prior to screening. 6. Positive test for alcohol or illicit drugs at screening or prior to dosing. 7. Other conditions or concomitant medications that are excluded by the protocol, or in the opinion of the investigator, or sponsor representative, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • CAN001

    RECRUITING

    Mississauga, Ontario, L4W 1N2, Canada

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