Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Lebrikizumab for Adults with Chronic Rhinosinusitis and Nasal Polyps Using Intranasal Corticosteroids

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Featured sites

Sites that work closely with us on this trial

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Chronic Rhinosinusitis with Nasal Polyps, a condition where the nasal passages become inflamed and develop growths called polyps. The study will evaluate the effectiveness and safety of a treatment called Lebrikizumab, which is given as a solution for injection. Participants will receive either Lebrikizumab or a placebo, while continuing their usual treatment with intranasal corticosteroids, which are medications sprayed into the nose to reduce inflammation.

The purpose of the study is to see how well Lebrikizumab works in reducing nasal congestion and the size of nasal polyps over a period of 24 weeks. Participants will be randomly assigned to receive either the treatment or the placebo, and neither the participants nor the researchers will know who is receiving which, to ensure unbiased results. The study will involve regular check-ups and assessments to monitor the condition of the participants and the effects of the treatment.

Throughout the study, participants will be asked to report their nasal congestion symptoms using a simple scale, and the size of their nasal polyps will be evaluated through a procedure called nasal endoscopy, which involves using a small camera to look inside the nose. The study aims to provide valuable information on whether Lebrikizumab can be an effective treatment option for people with Chronic Rhinosinusitis with Nasal Polyps.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed for individuals diagnosed with chronic rhinosinusitis with nasal polyps. This condition involves inflammation of the sinuses and the presence of polyps in the nasal passages.

    Eligibility is based on previous treatments, such as systemic corticosteroids or nasal surgery, and ongoing symptoms like nasal congestion and loss of smell.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of nasal congestion and the size of nasal polyps. This involves a nasal endoscopy, where a small camera is used to view the nasal passages.

    Participants are required to report the severity of their nasal congestion using a 4-point scale, ranging from no symptoms to severe symptoms.

  3. Step 3

    Treatment administration

    Participants receive either lebrikizumab or a placebo. Lebrikizumab is administered as a subcutaneous injection, which means it is injected under the skin.

    The treatment is given alongside ongoing use of intranasal corticosteroids, which are sprays used to reduce inflammation in the nasal passages.

  4. Step 4

    Ongoing monitoring

    Participants are monitored regularly to assess changes in nasal congestion and polyp size. This includes recording daily symptoms in an electronic diary.

    Endoscopic assessments are repeated to evaluate any changes in the nasal polyps.

  5. Step 5

    Final assessment

    At the end of the 24-week period, a final assessment is conducted to measure the effectiveness of the treatment.

    The primary focus is on the change in nasal congestion severity and the size of nasal polyps compared to the initial assessment.

Who can join the trial?

7 criteria

  • The patient must have a **doctor-diagnosed** condition called **chronic rhinosinusitis** with **nasal polyps** on both sides of the nose.
  • The patient should have been treated with **systemic corticosteroids** (a type of medication) in the last 2 years, or have a medical reason why they cannot take these medications, or have had surgery for nasal polyps.
  • The patient must have a **nasal polyp score** of at least 5 out of 8, with at least a score of 2 in each nasal cavity, as checked by a doctor using a special tool.
  • The patient should have ongoing symptoms for at least 8 weeks before joining the study, including:
  • **Nasal congestion** (stuffiness) that is moderate or severe, with a weekly average severity score of at least 1.
  • At least one other symptom, such as partial or total loss of smell, or runny nose.
  • If the patient has **asthma**, it must be stable for 3 months before joining the study, using allowed asthma treatments.

Who cannot join the trial?

8 criteria

  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had surgery for nasal polyps within the last 6 months.
  • Patients who have a known infection that is not well controlled.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of cancer within the last 5 years, except for certain types of skin cancer.
  • Patients who have a significant medical condition that the study doctor believes would make it unsafe for them to participate.
  • Patients who are unable to follow the study procedures or attend the required visits.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Lebrikizumab is a medication being studied for its ability to help reduce nasal congestion and the size of nasal polyps in adults with chronic rhinosinusitis. It is being tested to see how effective it is when used alongside regular nasal steroid sprays, which are commonly used to manage symptoms of this condition. The goal is to see if adding lebrikizumab can provide better relief from symptoms compared to using nasal sprays alone.

What is already known about the treatment

Lebrikizumab – This medication is administered via injection and is currently being studied in clinical trials for its effectiveness in treating chronic rhinosinusitis with nasal polyps. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for lebrikizumab is to reduce nasal congestion and the size of nasal polyps in patients who are already using intranasal corticosteroids. At the molecular level, lebrikizumab works by targeting and inhibiting interleukin-13, a protein involved in inflammatory responses. It is classified as a monoclonal antibody, which is a type of biologic drug designed to specifically target certain proteins in the body.

Investigated diseases

Chronic Rhinosinusitis With Nasal Polyps – This condition is characterized by long-term inflammation of the sinuses and nasal passages, often accompanied by the growth of polyps. These polyps are non-cancerous swellings that can obstruct nasal airflow and lead to symptoms such as nasal congestion, loss of smell, and facial pressure. The disease progresses with persistent symptoms that can fluctuate in severity, often requiring ongoing management. Over time, the presence of nasal polyps can lead to more significant breathing difficulties and a reduced quality of life. The condition is typically chronic, meaning it can last for several months or even years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508760-29-00Protocol codeJ2T-MC-KGBUEstimated enrolment1 017 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).