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Could a severe asthma drug also ease hayfever symptoms?

NCT ID NCT06189742

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether tezepelumab, a drug already approved for severe asthma, can also reduce nasal symptoms caused by hayfever in people who have both allergic asthma and allergic rhinitis. Nineteen participants will receive monthly injections of tezepelumab for 12 months, and their nasal symptoms and allergic markers will be measured after exposure to allergens. The study also includes a small group of non-allergic participants for comparison.

What this could mean

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

Active substance
Tezepelumab (a monoclonal antibody that blocks a protein involved in allergic inflammation)
What this could lead to
If it works, this could point toward a new treatment option for people with both allergic asthma and hayfever, reducing nasal symptoms after allergen exposure.
What could go wrong
This is a very small pilot study with only 19 participants, so results may not apply to everyone. It is also open-label, meaning both participants and researchers know who gets the drug, which can bias results.

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 19 people

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

Started

Jan 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: For inclusion in the study, all participants should fulfil the following criteria based on local regulations: 1. Must be able and willing to provide written informed consent. 2. Must be willing and able to comply with the study requirements. 3. People between the ages of 18 and 65. 4. Body weight greater than 45 kg. 5. A person of childbearing potential must be either abstinent or using a medically acceptable method of birth control (see Section 3.5) and produce a negative urine pregnancy test at the screening visit and again at each treatment visit. For inclusion in the study, non-allergic participants should fulfil the following additional criteria based on local regulations: 6. Negative skin prick test to all relevant aeroallergen at screening with a wheal diameter no larger than that produced by the negative control. 7. Specific IgE levels to a relevant allergen are undetectable. 8. Negative screening Nasal Allergen Challenge, defined by a TNSS response of ≤ 3 (on a 12-point scale) and a decrease in PNIF of ≤ 30% after 10 minutes in response to a nasal application of a relevant aeroallergen extract. For inclusion in the study, allergic participants should fulfil the following additional criteria based on local regulations: 9. A minimum 2-year documented history of rhinoconjunctivitis symptoms to a relevant aeroallergen. 10. Positive skin prick test to a relevant aeroallergen at screening (matching the history in IC2) with a wheal diameter at least 5 mm larger than that produced by the negative control. 11. A minimum 2-year documented history of asthma, controlled with either moderate or high dose inhaled corticosteroids with or without another controller medication (long-acting beta-agonists and/or montelukast and/or a long-acting muscarinic antagonist. 12. Positive screening Nasal Allergen Challenge, defined by a TNSS response of ≥ 7 (on a 12-point scale) and a decrease in PNIF of ≥ 50% after 10 minutes in response to a nasal application of a relevant aeroallergen extract. Exclusion Criteria: Participants should not enter the study if any of the following exclusion criteria are fulfilled: 1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site). 2. Is unlikely to cooperate with the requirements of the study including having the ability to communicate with the investigator appropriately. 3. Inability to attend study visits or adhere to the study protocol, in the judgment of the principal investigator. 4. Previous enrolment in the present study. 5. Participation in another clinical study with an investigational product during the last 30 days. 6. Known hypersensitivity to the investigational product. 7. Currently uses or is expected to use any of the prohibited medications or other treatments as listed in Section 7.7. 8. An upper respiratory tract infection within 14 days of the NAC portion of the screening visit or baseline NAC visit. 9. History of immunological disorders or other diseases (including, but not limited to malignancy, cardiovascular, gastrointestinal, hepatic, renal, haematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator may pose additional risk factors for participation. Participants with basal cell carcinoma or squamous cell carcinoma that has been excised in the past 5 years may still participate in the study. 10. Nasal conditions that, according to the opinion of the investigator, may affect the outcome of the study, i.e. nasal septal perforation, current nasal polyps, other nasal malformations or history of frequent nosebleeds. 11. A known history of positive test results for Hepatitis B, Hepatitis C, HIV or tuberculosis other than what would be anticipated following vaccination. 12. Participant has a known history of current or previous parasitic infection. 13. Participant that is pregnant, lactating or actively trying to become pregnant. 14. Participant with a clinically relevant abnormality on physical examination. 15. Participant is unable to communicate or to understand the requirements of the study, which would impair communication between the participant and the investigator. 16. Significant history of alcohol or drug abuse, in the judgment of the investigator. 17. Serious asthma exacerbation requiring a hospital visit and/ or treatment with oral steroids within 4 weeks prior to screening. 18. FEV1 \< 40 % predicted at screening. 19. Pre-NAC TNSS \> 4 at the screening and baseline NAC visit.

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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.

Contacts and locations

Locations

  • Kingston Health Sciences Centre- Kingston General Hospital

    Kingston, Ontario, K7L 2V7, Canada

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Other studies related to the condition(s) this trial covers.