Study on the Effects of Itepekimab for Patients with Non-Cystic Fibrosis Bronchiectasis

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What is this study about?

This clinical trial is focused on studying a lung condition called non-cystic fibrosis bronchiectasis. This condition involves damage to the airways, leading to symptoms like a persistent cough and frequent lung infections. The study will test a treatment called itepekimab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific substances in the body. Itepekimab is designed to target and block a protein called interleukin-33, which is involved in inflammation.

The purpose of the study is to evaluate how effective itepekimab is compared to a placebo in reducing lung flare-ups, known as pulmonary exacerbations, in people with non-cystic fibrosis bronchiectasis. Participants in the study will receive either itepekimab or a placebo through an injection under the skin. The study will monitor participants over a period to see how often these lung flare-ups occur and to assess the safety and tolerability of the treatment.

Throughout the study, various aspects will be observed, such as the time it takes for the first lung flare-up to occur, the number of participants who remain free from these flare-ups, and any changes in lung function. The study will also look at the quality of life related to respiratory symptoms and any side effects that may arise from the treatment. The goal is to gather information that could help improve the management of non-cystic fibrosis bronchiectasis in the future.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the itepekimab treatment or a matched placebo. This process is double-blind, meaning neither the participant nor the researchers will know which treatment is being administered.

2 treatment administration

The treatment involves a subcutaneous injection of itepekimab or placebo. The solution is provided in a pre-filled syringe for ease of administration.

The frequency and dosage of the injections will be determined by the study protocol and communicated to the participant at the start of the trial.

3 monitoring and assessments

Throughout the study, the participant will be monitored for any changes in their condition, specifically focusing on the occurrence of pulmonary exacerbations (PEs).

Regular assessments will be conducted to evaluate lung function, using a measure called FEV1, which stands for forced expiratory volume in one second. This will be checked at specific intervals, such as Week 8 and Week 24.

4 quality of life evaluations

The participant’s quality of life will be assessed using standardized questionnaires, such as the QOL-B Respiratory Symptoms Domain Score and the SGRQ (St. George’s Respiratory Questionnaire).

These evaluations will help determine any changes in symptoms and overall well-being at different points during the study, particularly at Week 24.

5 safety monitoring

Safety is a priority, and the participant will be monitored for any adverse effects, including treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Blood samples may be taken to measure serum concentrations of itepekimab and to check for any immune responses against the treatment.

6 completion of the study

The study is expected to conclude by August 2026. Upon completion, the participant will undergo a final assessment to evaluate the overall impact of the treatment on their condition.

Who Can Join the Study?

  • Participant must be between 18 and 85 years old.
  • Have a clinical history that matches symptoms of non-cystic fibrosis bronchiectasis (NCFB), such as a persistent cough, ongoing production of mucus, or frequent lung infections.
  • Have a FEV1 (Forced Expiratory Volume in one second) that is at least 30% of what is predicted for a healthy person. This is a measure of how much air you can forcefully exhale in one second.
  • Have experienced at least 2 moderate or 1 severe pulmonary exacerbations (PEs) in the past year. A pulmonary exacerbation is a worsening of lung symptoms.

Who Cannot Join the Study?

  • Patients with a history of cystic fibrosis. Cystic fibrosis is a genetic disorder that affects the lungs and other organs.
  • Patients who have had a lung transplant. A lung transplant is a surgery to replace a diseased lung with a healthy one from a donor.
  • Patients with active tuberculosis. Tuberculosis is a serious infectious disease that mainly affects the lungs.
  • Patients with a history of cancer within the last 5 years, except for certain types of skin cancer. Cancer is a disease where cells in the body grow uncontrollably.
  • Patients with HIV infection. HIV is a virus that attacks the body’s immune system.
  • Patients with hepatitis B or hepatitis C. These are viral infections that affect the liver.
  • Patients who are currently pregnant or breastfeeding. Pregnancy is the period during which a baby develops inside the mother’s womb, and breastfeeding is feeding a baby with milk from the mother’s breast.
  • Patients who have participated in another clinical trial within the last 30 days. A clinical trial is a research study to test new treatments.
  • Patients with a known allergy to the study medication or its ingredients. An allergy is a reaction by the immune system to something that is usually harmless.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
IRCCS Humanitas Research Hospital Rozzano Italy
Institut für Allergie- und Asthmaforschung Berlin Berlin Germany
University Hospital Jena KöR Jena Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Amphia Hospital Breda The Netherlands
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Santa Sp. z o.o. Lodz Poland
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Pectus Respiratory Health S.L. Girona Spain
MediTrial s.r.o. Jindřichův Hradec Czechia
MECS Medical and Clinical Studies Cottbus GmbH Cottbus Germany
Fakultni Nemocnice Plzen Plzen Czechia
Velocity Clinical Research Luebeck GmbH Luebeck Germany
University General Hospital Of Ioannina Ioannina Greece
Prvni plicni ambulance s.r.o. Prague Czechia
Odense University Hospital Odense Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Aalborg University Hospital Aalborg Denmark
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire De Nice Nice France
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Uvlhbmyoerkmiauvqzhvl Ewngm Acb Essen Germany
Hfunpxht Upceihoaeoiuv Mjhbgrb Dh Vakspkfsjn Santander Spain
Ohydjwxvzobs Cppkkjv Mgpicmky Ascf Opopw Cszlxw Kwgannnfq Ctwdch safi Ostrowiec Swietokrzyski Poland
Israyrzrxuiq Sqjqkfssrhiterp Pfsebvoo Lpujiksq Krmbbwhlr Bolos Wejherowo Poland
Pjqisk Rlhjsaoezjr Hefbuo Sgoc Barcelona Spain
Pvkhpt Tle surrww Latran Czechia
Pbtzni agkxustvh Kdkwafw siuzrw Prague Czechia
Lwsyi Gbgwvzz Hzedwsra Oi Aaluym Athens Greece
Ayffvjjsl Uga Amsterdam The Netherlands
Ehqpyjs Uwrptajribce Meejshf Cmjgjcz Rqlzusrlr (xkbsybf Mqz Rotterdam The Netherlands
Aemrqm Usfzchotsv Hvmssgpc Aarhus Denmark
Atrqfolns Ujq Amsterdam The Netherlands
Kbjjbvat dyd Uzvjpccdrklm Mjugulir Atq Munich Germany
Aisotwi Ulg Ivrqn Da Rgtwpc Epgqii Reggio Emilia Italy
Klfm Givl Bendorf Germany
Hdgaxlns Vgvc debzxbtm Barcelona Spain

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
10.06.2024
Denmark Denmark
Not recruiting
10.06.2024
France France
Not recruiting
10.06.2024
Germany Germany
Not recruiting
10.06.2024
Greece Greece
Not recruiting
10.06.2024
Italy Italy
Not recruiting
10.06.2024
Poland Poland
Not recruiting
10.06.2024
Spain Spain
Not recruiting
10.06.2024
The Netherlands The Netherlands
Not recruiting
10.06.2024

Trial locations

Investigated drugs:

Itepekimab is a medication being studied for its potential to help people with non-cystic fibrosis bronchiectasis. This condition involves damage to the airways in the lungs, leading to frequent lung infections and difficulty breathing. The trial aims to see if itepekimab can reduce the number of lung flare-ups, known as pulmonary exacerbations, in people with this condition. The study is designed to test how effective, safe, and well-tolerated itepekimab is for these patients.

Investigated diseases:

Bronchiectasis – This is a chronic lung condition where the airways become widened and scarred, leading to a build-up of mucus. This can cause frequent lung infections and persistent coughing. Over time, the airways lose their ability to clear out mucus, which can result in further lung damage. People with bronchiectasis often experience symptoms like shortness of breath, fatigue, and wheezing. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more severe respiratory issues. It is important to manage the condition to prevent further lung damage and maintain quality of life.

Trial ID:
2023-508663-70-00
Protocol code:
ACT18018
Trial Phase:
Therapeutic exploratory (Phase II)

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