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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Azienda Ospedaliero Universitaria Careggi Florence Italy
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario De Navarra Pamplona Spain
Rhinoto Kft. Pecs Hungary
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Alergologia Plus Sp. z o.o. Poznan Poland
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Cardiomed S.R.L. Cluj Napoca Romania
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Unidade Local De Saude De Loures-Odivelas EPE Loures Portugal
Cavrecmbw Urnjhfdlveinwm Smlfdqwxz Woluwe-Saint-Lambert Belgium
Aijqjxs Ojtglgeendx dp Pyohcu Padua Italy
Ccmvvhv Uitbqgbequlooffdulpk Bmdodj Khr Berlin Germany
Hfqhftxz Urjxldjptu Cofchzb Hetlmcyn Helsinki Finland
Hgzpybij Uepijaplgijqh Fmjnhhsha Juahxqt Dtop Madrid Spain
Urblhuhwcake Dz Sncsldmu Du Cuojdklyoh Santiago De Compostela Spain
Awiwokc Uvpfcdajtk Hegxmueu Aalborg Denmark
Aqgjlhe Owsotvicife Utqgkzlmdvhnd Fatuvtkb Ip De Nzlpnx Naples Italy
Pukehwh Skp z orbo Katowice Poland
Utkaacpkbhjg Zajanruyij Gmoq Gent Belgium
Hrwlhomi Sbre Jvms Dw Dlz Biqhoiyox Esplugues De Llobregat Spain
Uzzqldohcrbjraohcykwi Srlvqapdjhgbjjassh Aaa Kiel Germany
Cxwoxlh Mdmkaua Dm Drvvpauoxp Sg Taexwnram Aleurxisk Ndacmt Sshpml Brasov Romania
Dbeif Hhlypo Cnqj Sjlvhz Bucharest Romania
Cfji Cqnuhf Ciinshr Awvqhtxnl Blofd Agfdezpokw Braga Portugal
Ics Piyonvpmkfu Gmsf &llbi Csk Kb Frankfurt Germany
Monloef Cdldjt Mrdqcvwupi Pcjrhx Oqj Pleven Bulgaria
Aibpywk Oftlfcesihb Ujwalfulokepk Pctxgl Pisa Italy
Pgzmvx fdg Hrm usy Afkhtjjsgcfa Ddl Yhbw Yyldn Dresden Germany
Dzgbthdktz Ctajfzjkqued Cxuthd Apzfvcdlm Oyd Sofia Bulgaria
Avrorkx Szxtm Syxibxxma Tzepkldrlgop Dazfy Bnahhng Vimercate Italy
Ctvtrti Dz Exyqsiszk Ij Rdwoooyvs Slvqlp Craiova Romania
Uyeomhq Ecicdzwlqntx Neiuuvufx Kzqi Budapest Hungary
Akidho Uwljvkeoxo Hdtcujib Aarhus Denmark
Mmnvbstuzjer Hfcxzwdl Fpt Agoojx Tsmwwpjsh Drq Tceb Vjdhmkw Ae Gabrovo Bulgaria
Cahvae Hftapxcnbb Ds Bpgea Vmtbh Eyiraz (nijb Evndzrv Aveiro Portugal
Etq Ielbvcfh Mpkctzao Srmr Wroclaw Poland
Cyujrkx Mkppnvq Ufwjyh Sumgkj Brasov Romania
Kspimieaujddkgtcr Vlgspclud Sjaym Brooecm Kkycuk Tatabanya Hungary
Ppieqr Ppgddw Rvsfzccrns Sls jj Cracow Poland
Czfdhma Mdpezpff Osukme Wroclaw Poland
Ckxvjie Mfsajctp Adzrblq Bmqrgyw Kyvkwkjtr Cracow Poland
Ukkvwyo Lvguo Dv Sfjru Du Mgxuzkdbcv Ecuyza Senhora Da Hora Portugal
Psadefywde Namur Belgium
Nsuo Eqdnw Skh z ovsu Bialystok Poland
Bpwxwdg Cnprevqs Swk z oxma Kielce Poland
Hzd Pgkfmo Ddcsicb Dco mdws Ueq Stolpfv Dresden Germany
Crlpmwr Macycukj Phgolk Klszlhim Katowice Poland
Hpa Zahhpuj as Kypxyl Berlin Germany
Mqbnavje moclhxm aurrdnx &tbqxmk Mfgo &jfpwqe Srjgz Sofia Bulgaria
Zavpdwp Utqcebvccn Hxgsqqwn Koege Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.09.2024
Bulgaria Bulgaria
Recruiting
15.09.2024
Denmark Denmark
Recruiting
15.09.2024
Finland Finland
Not yet recruiting
15.09.2024
Germany Germany
Recruiting
15.09.2024
Hungary Hungary
Recruiting
15.09.2024
Italy Italy
Recruiting
15.09.2024
Poland Poland
Recruiting
15.09.2024
Portugal Portugal
Recruiting
15.09.2024
Romania Romania
Recruiting
15.09.2024
Spain Spain
Recruiting
15.09.2024

Trial locations

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.

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 ID:
2023-508760-29-00
Protocol code:
J2T-MC-KGBU
NCT ID:
NCT06338995
Trial Phase:
Therapeutic confirmatory (Phase III)

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