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New drug could ease constant allergy symptoms

NCT ID NCT06339008

Symptom relief Sponsor: Eli Lilly and Company 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 25, 2026 · Updated 5 times

Summary

This phase 3 study tests lebrikizumab, an injectable drug, in 450 adults with perennial allergic rhinitis (year-round allergies). The goal is to see if it reduces nasal symptoms like congestion and sneezing compared to a placebo. Participants will be followed for up to 29.5 months.

What this could mean

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

Active substance
lebrikizumab
What this could lead to
If it works, this could offer a new treatment option for people with year-round allergies, reducing nasal symptoms like congestion and sneezing.
What could go wrong
This is a phase 3 trial, but it's still experimental. The drug may not work better than placebo, and there could be side effects. Results may not apply to everyone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 450 people

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

Started

Apr 2024

Expected to finish

Oct 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 years and older

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: * Physician-diagnosed perennial allergic rhinitis (PAR). * Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory). * The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum antigen-specific IgE test. * A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test. * Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment. Exclusion Criteria: * Have received a dose of lebrikizumab. * Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible. * Have received treatment with any rescue medication during the run-in period. * Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease prior to the baseline visit: * Any current or prior use of biologics indicated for asthma or AD are prohibited. * B cell-depleting biologics, including rituximab, within 6 months. * Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer. * Systemic immunosuppressants, including JAK inhibitors, within 4 weeks prior to baseline. * Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 8 weeks of the maintenance period. * Anticipates significant changes in their daily environmental exposure. * Has a known history of recurrent acute or chronic sinusitis. * Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.

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Conditions

The condition(s) this trial relates to.

perennial allergic rhinitis

As listed by the trial registrant

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

Perennial allergic rhinitis (PAR)

Contacts and locations

Locations

  • 310 Clinical Research

    Inglewood, California, 90301, United States

  • AARA Research Center

    Dallas, Texas, 75231, United States

  • ALL-MED - Specjalistyczna Opieka Medyczna

    Wroclaw, 53-201, Poland

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

    Tarnów, 33-100, Poland

  • Allergy & Asthma Associates of Southern California dba. Southern California Research

    Laguna Niguel, California, 92677, United States

  • Allergy Partners

    Asheville, North Carolina, 28803, United States

  • Allergy and Asthma

    San Diego, California, 92123, United States

  • Allergy and Asthma Consultants

    St Louis, Missouri, 63141, United States

  • Allergy and Asthma Diagnostic Center

    Tallahassee, Florida, 32308, United States

  • Allergy and Asthma Specialists Medical Group

    Huntington Beach, California, 92648, United States

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241, United States

  • Allergy, Asthma & Sinus Center

    Greenfield, Wisconsin, 53228, United States

  • Asthma Allergy Center of Chicago

    River Forest, Illinois, 60305, United States

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado, 80907-6231, United States

  • Asthma and Allergy Center

    Bellevue, Nebraska, 68123, United States

  • B1F, Pharmacy department, Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45236, United States

  • Bluegrass Allergy Research

    Lexington, Kentucky, 40509, United States

  • Centrum Alergologii Teresa Hofman Sp z.o.o.

    Piła, 64-920, Poland

  • Centrum Medyczne Promed ul. Olszańska 5G

    Krakow, 31-513, Poland

  • Charité - Universitätsmedizin Berlin Klinik für Dermatologie

    Berlin, 10117, Germany

  • Circuit Clinical/Hudson-Essex Allergy

    Belleville, New Jersey, 07109, United States

  • Circuit Clinical/Mercer Allergy and Pulmonary Associates

    Hamilton, New Jersey, 08619, United States

  • ClinMedica Research

    Skierniewice, 96-100, Poland

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402, United States

  • Clinical trial Pharmacy

    Seoul, 8308, South Korea

  • Department of Nasal Allergy

    Beijing, 100730, China

  • Dr. Patrick Perin

    Teaneck, New Jersey, 07666, United States

  • EMED Centrum Usług Medycznych

    Rzeszów, 35-205, Poland

  • ETG Lublin

    Lublin, 20-412, Poland

  • ETG Warszawa

    Warsaw, 02-793, Poland

  • GCP Pharmacy

    Guangzhou, 510000, China

  • Gangnam Severance Hospital 211

    Seoul, 6273, South Korea

  • Hôpital Erasme, Service Pharmacie

    Brussels, 1070, Belgium

  • Hôpital de la Citadelle

    Liège, 4000, Belgium

  • IKF Pneumologie

    Frankfurt am Main, 60596, Germany

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Internal Medicine Building

    Beijing, 100032, China

  • Jingzhou Central Hospital

    Jingzhou, 434020, China

  • Kerrville Allergy and Asthma Associates

    Kerrville, Texas, 78028, United States

  • Kyunghee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • Malopolskie Centrum Alergologii

    Krakow, 31-623, Poland

  • Northern Jiangsu People's Hospital

    Yangzhou, 225001, China

  • Northwest Research Center

    Portland, Oregon, 97202, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Outpatient Department, Union Hospital

    Wuhan, 430022, China

  • Outpatient building

    Wuhan, 430014, China

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530021, China

  • Pneumocare

    Erpent, 5101, Belgium

  • Polimedica PTG Kielce

    Kielce, 25-355, Poland

  • Praxis für HNO und Allergologie

    Dresden, 1139, Germany

  • Renmin Hospital of Wuhan University

    Wuhan, 430060, China

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan, 48197, United States

  • SMG-SNU Boramae Medical Center

    Seoul, 7061, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Siteworks - Zentrum für klinische Studien Heidelberg

    Heidelberg, 69115, Germany

  • Smith Allergy and Asthma

    Horseheads, New York, 14845, United States

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330006, China

  • The Third Xiangya Hospital of Central South University

    Changsha, 410013, China

  • Tongji Hospital

    Shanghai, 200065, China

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven, Pharmacy

    Leuven, 3000, Belgium

  • University of Missouri Hospital

    Columbia, Missouri, 65212, United States

  • University of South Florida

    Tampa, Florida, 33613, United States

  • Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie

    Marburg, 35043, Germany

  • Universitätsklinikum Carl Gustav Carus an der TU

    Dresden, 1307, Germany

  • Yangzhou University

    Yangzhou, 225012, China

  • Zentrum für Rhinologie und Allergologie

    Weisbaden, 65183, Germany

  • Zhejiang People's Hospital

    Hangzhou, 310014, China

  • Zhongshan City People's Hospital

    Zhongshan, 528403, China

  • gab. 114, ul. inż. pilota Wigury

    Lodz, 90-302, Poland