Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New combo therapy may offer lasting hay fever relief

NCT ID NCT04502966

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at whether taking a grass pollen tablet (SLIT) together with the drug dupilumab for 2 years can help adults with moderate to severe hay fever tolerate grass pollen better, even after stopping treatment. About 199 participants were involved. The main goal was to see if this combination reduces nasal allergy symptoms during a pollen challenge one year after treatment ends.

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

199 people

The number who actually took part.

Started

Nov 2020

Finished

Feb 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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

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: * Participant must be able to understand and provide informed consent * A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years, with peak symptoms in May, June, or July * A clinical history of moderate to severe rhinoconjunctivitis symptoms for at least 2 years, interfering with usual daily activities or with sleep as defined according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) classification of rhinitis * A clinical history of inadequately controlled rhinoconjunctivitis symptoms, despite treatment with antihistamines and/or nasal corticosteroids during the grass pollen season, for at least 2 years * Positive skin prick test response at screening, defined as wheal diameter ≥3 mm to Phleum pratense * Positive specific immunoglobulin E (IgE) at screening, defined as IgE class 2 (e.g., ≥ 0.7 kilounits per liter \[kU/L\]) against Phleum pratense * A woman of childbearing potential (WOCBP), regardless of birth control history, must: * have a negative serum pregnancy test at screening, * not be breast-feeding or lactating, and ---is required to consistently use one of the following highly effective methods of contraception throughout the study: * hormonal (e.g. oral, transdermal, intravaginal, implant, or injection), * intrauterine device (IUD) or system (IUS), * vasectomized partner, * bilateral tubal occlusion, or * sexual abstinence. Exclusion Criteria: * Inability or unwillingness of the Subject to give written informed consent or to comply with study protocol requirements * Prebronchodilator forced expiratory volume (FEV1) \<70% of predicted value at either Screening Visit or Baseline (Visit 0) Visit * A clinical history of asthma requiring regular inhaled corticosteroids for \>4 weeks per year, outside of the grass pollen season * A clinical history of moderate to severe allergic rhinitis, as defined according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) classification of rhinitis, caused by either: * An allergen to which the Subject is regularly exposed, or * Tree pollen during tree pollen season, treated with regular antihistamine or intranasal corticosteroids * History of emergency visit or hospital admission for asthma in the previous 12 months * History of chronic obstructive pulmonary disease * History of recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment * History of chronic sinusitis, defined as a sinus symptoms lasting greater than 12 weeks, that includes 2 or more major factors or 1 major factor and 2 minor factors. * Major factors are defined as: * Facial pain or pressure, * Nasal obstruction or blockage, * Nasal discharge or purulence or discolored postnasal discharge, * Purulence in nasal cavity, or * Impaired or loss of smell. * Minor factors are defined as: * Headache, * Fever, * Halitosis, * Fatigue, * Dental pain, * Cough, and/or * Ear pain, pressure, or fullness. * History of systemic disease affecting the immune system, such as autoimmune diseases, immune complex disease or immunodeficiency * At randomization: Current symptoms of, or treatment for: * Upper respiratory tract infection, * Acute sinusitis, * Acute otitis media, or * Other relevant infectious process ---Note: 1.) Serous otitis media is not an exclusion criterion and 2.) Participants may be re-evaluated for eligibility after symptoms resolve. * A past history of any malignant disease in the previous 5 years * Any tobacco smoking within the last 6 months, or a history of greater than or equal to 10 pack years of cigarette use. * Any vaping or electronic cigarette use within the last 6 months * Previous immunotherapy with grass pollen allergen within the previous 5 years * Previous treatment by dupilumab (Dupixent®) * Previous Grade 4 anaphylaxis (World Allergy Organization grading criteria), due to any cause * History of anti-IgE, anti-IL-5, anti-IL-5 receptor, anti-IL-4/IL-13 receptor, or other monoclonal antibody treatment * Use of tricyclic antidepressants or monoamine oxidase inhibitors * Ongoing systemic immunosuppressive treatment * History of intolerance to the study therapy, rescue medications, or their excipients * For women of childbearing age a positive serum or urine pregnancy test with sensitivity of less than 50 milli-international units per milliliter \[mIU/ml\] within 72 hours before the scheduled start of study therapy * The use of any investigational drug within 30 days of the Screening Visit * The presence of any medical condition that the investigator deems incompatible with participation in the trial * Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study * Eosinophilic esophagitis or a diagnosis of any hypereosinophilic syndrome, and/or * Administration of live attenuated vaccines within four weeks of dupilumab or dupilumab placebo injections, before the first injection and throughout the treatment period.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Allergic rhinoconjunctivitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Royal Brompton Hospital

    London, SW36HP, United Kingdom

More trials for these conditions

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