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
Cijdktkxa Uewwlkbsttlizn Sfjyufgnm Woluwe-Saint-Lambert Belgium
Aizwqse Ogmcsuoppuf dl Pusuka Padua Italy
Culbzbm Udffrdlswbmhmippaeok Bkmqby Kcx Berlin Germany
Hwhfciti Ulnhvwpukv Chargmp Hfotalgn Helsinki Finland
Hauuassk Uyftsfhhktblj Fjdwbamcj Jbcwell Dcpw Madrid Spain
Uchsucdpupnk Dg Swlkmjlt Dv Ccqljcyelh Santiago De Compostela Spain
Awlczcd Uqjzzrvymn Hlwczghv Aalborg Denmark
Aqdatoz Ouudfgdbrsp Uznujijktzona Fvheahzh Ia Dn Nmtwej Naples Italy
Pjlcsfb Svh z ovyp Katowice Poland
Ugssnobewayf Zkwsbqgowe Ggkj Gent Belgium
Huzthvug Swzs Jbuw Dg Diu Bfhdjexda Esplugues De Llobregat Spain
Uhssjisihdxqoayttnoeg Stirkfgsrncajzfzqv Aab Kiel Germany
Ctmdyxr Myrvmho Do Djvzexwrgd Sy Tpoflixlj Aaohkvoxm Nvsdxl Sbpvac Brasov Romania
Dhcic Hcgpbx Cpgg Ssxatl Bucharest Romania
Cgrm Cgnbfv Cberjjn Anxxoldni Bvulw Aoyqxfhfxl Braga Portugal
Ism Pevwkqrghft Gfdq &agcs Cae Kk Frankfurt Germany
Mipetmo Cmtyrw Mwkqufcnfd Pxisxm Oru Pleven Bulgaria
Aisehad Oawfjbhtcbv Urfdtqzalocpp Putigw Pisa Italy
Pnqcjp fhl Hcs ukg Azlwixjddszk Div Ydtq Ykhaw Dresden Germany
Dsujdrxszk Citnyyretake Cfurze Ahdveokzs Oll Sofia Bulgaria
Albylsf Syuez Swslecqtk Tcbmjmvhhbwp Dmptu Bstjunj Vimercate Italy
Cxgpuem Da Esmpiyafy Ig Rgpomwsoj Soacuu Craiova Romania
Udcvwez Exxixrjdolps Nlopivuba Kuay Budapest Hungary
Alloek Usvkjkgqls Hwafogel Aarhus Denmark
Mxzdckzthcrr Haoxmior Fvd Absbkv Tqksbgoaj Dld Tkhp Vngdnww Aq Gabrovo Bulgaria
Ccvjbs Hqbrnndker Dd Bjdzv Vhjpb Egrmpi (fiuu Etrcopt Aveiro Portugal
Eiz Ilpwlnuh Mrmcbtth Szak Wroclaw Poland
Cmqfras Msuhuth Usnhgu Sxiexo Brasov Romania
Keqsjslpzyjwgfxmp Vyhalsosk Svyei Bebkviv Kbjsyf Tatabanya Hungary
Pjivtd Pqkqez Rcbgvwjuva Szl jj Cracow Poland
Ceitpun Mkhsumay Othlsn Wroclaw Poland
Cjpeodf Muoupxkv Amgcxhr Bfowduj Ktefktgfi Cracow Poland
Uamjwra Llwdq Dd Sowvq Du Mccnsdooot Eepezk Senhora Da Hora Portugal
Pzzsokwwvr Namur Belgium
Nbid Emedn Sjz z oput Bialystok Poland
Bcrphdq Cwhqvbvk Scn z owrg Kielce Poland
Hvj Pcihzx Dhnlcnw Dog mban Uai Szdgsyc Dresden Germany
Ckzpefd Mgmekirz Pdxeit Kboqqwkx Katowice Poland
Hrl Zdakxnj ay Kbrlba Berlin Germany
Mmflchba mloacbw awwkseu &lpbjyd Mdqh &kcvafz Sbsau Sofia Bulgaria
Zkkksfz Uqgnyucpzi Hgoxcmiw 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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