Long‑term safety and tolerability of itepekimab in adults with inadequately controlled chronic rhinosinusitis with nasal polyps: an extension study

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What is this study about?

The study focuses on adults who have Chronic rhinosinusitis with nasal polyps, a condition where the lining of the nose and sinuses stays inflamed for a long time and small growths called polyps develop, making breathing difficult and causing a runny nose or loss of smell. Participants will receive either the investigational medicine itepekimab, given as a subcutaneous injection (a shot under the skin), or a matched placebo that looks the same but does not contain the active drug.

The main goal is to assess the long‑term safety and tolerability of the medicine, meaning researchers will watch for any side effects or problems over an extended period. After the initial treatment period, participants will continue to attend regular visits where doctors will ask about health changes, perform a simple nasal examination, and may take a small blood sample to check drug levels. The study also records whether participants need additional treatments such as a short course of a systemic corticosteroid (a pill that reduces inflammation throughout the body) or sinus surgery.

1 screening and enrollment

after joining the study, you undergo screening procedures to confirm eligibility based on your chronic rhinosinusitis with nasal polyps condition.

the screening includes medical history review, physical examination, and baseline measurements that will be used for later comparisons.

2 baseline visit

at the baseline visit, detailed assessments of nasal polyps, symptom scores, and laboratory tests are performed.

the results establish your starting point for evaluating safety and tolerability during the extension study.

3 randomization and first injection

you are randomly assigned to receive either itepekimab or a matched placebo. the assignment is double‑blinded, meaning neither you nor the study staff know which product you receive.

itepekimab is administered by subcutaneous injection (injection under the skin) using a pre‑filled syringe. the labeled dose is 00 mg, as defined by the protocol.

the matched placebo is administered in the same manner, without active drug.

4 regular injection visits

you return to the study site for additional injections according to the schedule defined in the protocol. each visit includes the same subcutaneous administration of either itepekimab or placebo.

the exact interval between injections (for example, every 4 weeks) is specified by the study protocol, but is not detailed in the provided information.

5 safety monitoring visits

at each visit, health professionals assess you for any adverse events, including serious or treatment‑emergent events.

laboratory tests may be performed to monitor blood chemistry and immune response, including detection of anti‑drug antibodies.

6 interim assessments

periodically, endoscopic examination of nasal polyps and symptom questionnaires are repeated to track changes from the baseline of the parent studies.

functional itepekimab concentration in serum may be measured to evaluate drug exposure.

7 final visit and study end

at the conclusion of the extension period, a final assessment is performed, including safety evaluation, endoscopic examination, and collection of any remaining study data.

after the final visit, the study drug is discontinued and you are no longer required to attend study visits.

Who Can Join the Study?

  • You must have chronic rhinosinusitis with nasal polyps (CRSwNP) and have finished a previous 52‑week study of the medicine itepekimab (study IDs EFC18418 or EFC18419).
  • Your last visit in that previous study (the end‑of‑treatment (EOT) visit) must have taken place no more than 5 days before you come to this study.
  • Both men and women are allowed to take part.
  • If you are a woman, you must not be pregnant or breastfeeding.
  • If you are a woman who could become pregnant (woman of childbearing potential), you must agree to follow the study’s birth‑control instructions during the treatment period and for at least 20 weeks after the last dose.

Who Cannot Join the Study?

  • Having been diagnosed with a malignancy (a type of cancer) during the earlier study, unless it was a skin cancer called squamous cell carcinoma or basal cell carcinoma.
  • Having any opportunistic infection (an infection that occurs when the immune system is weakened) during the earlier study, such as tuberculosis (TB) or other infections that suggest the immune system is not working well.
  • Having had a severe allergic reaction (anaphylactic reaction) or a whole‑body allergic reaction (systemic allergic reaction) that was linked to the study drug (IMP) and needed treatment during the earlier study.
  • Any other situation that caused the study drug (IMP) to be stopped permanently and early in the earlier trials.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany
Kuopio University Hospital Kuopio Finland
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
Katholieke Universiteit te Leuven Leuven Belgium
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario De Navarra Pamplona Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain
Rhinoto Kft. Pecs Hungary
Medical University Of Vienna Vienna Austria
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.) Aveiro Portugal
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Universitaire De Poitiers Poitiers France
Universitair Ziekenhuis Gent Gent Belgium
Unidade Local De Saude De Entre O Douro E Vouga E.P.E. Santa Maria Da Feira Portugal
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Pneumocare Namur Belgium
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Alrijne Zorggroep Stichting Leiderdorp The Netherlands
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Azienda Ospedaliera di Padova Padua Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Region Midtjylland Aarhus Denmark
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Instituto Di Ricovero E Cura A Carattere Scientifico Bologna Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Del Mar Barcelona Spain
Universita’ Degli Studi Di Ferrara Ferrara Italy
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
University Of Debrecen Debrecen Hungary
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Alergologia Plus Sp. z o.o. Poznan Poland
Santa Sp. z o.o. Lodz Poland
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Revit Sp. z o.o. Bialystok Poland
Centrul Medical Unirea S.R.L. Brasov Romania
Pracownia Badan Klinicznych Salus Wroclaw Poland
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
University Of Szeged Szeged Hungary
Region Sjaelland Holbæk Denmark
Dobrostan Gabinet Lekarskie Wroclaw Poland
Gdef Gkntkoxhmsve fvxp Eutdythgzjhlom ukq Kztmvcqtq Attevorlyhhuahcfi moa Wiesbaden Germany
Onfynvpgzajdk Svgedflrg Aw Stockholm Sweden
Avfecoeeyv Pjfkjmsg Hcqlipav Dp Midohkqqd Marseille France
Hciekfzk Uuiwgkprvx Cjhounn Hxsyxamr Helsinki Finland
Atuebvrxz Ugg Amsterdam The Netherlands
Fxupasgj nngicycjm Mvftr a Hfvvdco Prague Czechia
Pjoa Twfnt Hxhkkpuq Upnqyaeimujm Sabadell Spain
Umypzdefdhvcopdfitaoj Mcnapgei Awa Munster Germany
Uwfetebpymuptierjnnze Whdtxmsbq Awa Wuerzburg Germany
Hlemlwzh Ugeuvzawkxmsz Mgpxyxf Dv Vyltehyitx Santander Spain
Swlceil Sdbsflkd Ltecbdh Smys Bielsko-Biala Poland
Rqf Myzdotn Zhhf Budapest Hungary
Vjdyucqx &chcl Vavysel Saz z odwz Wroclaw Poland
Ojuqlcrywmaeam Lpye Goln Linz Austria
Cjxspal Dn Edesvdapl Iv Rkboaknob Saqpaz Craiova Romania
Cuhlwlq Mxepjty Du Dnklruxpsz Sq Txjawhyqn Adssqmciq Npndcy Scwset Brasov Romania
Uuqzwev Ekvnfudtygdc Nwezzowum Kwfq Budapest Hungary

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

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
23.06.2026
Belgium Belgium
Not yet recruiting
23.06.2026
Czechia Czechia
Not yet recruiting
23.06.2026
Denmark Denmark
Not yet recruiting
23.06.2026
Finland Finland
Not yet recruiting
23.06.2026
France France
Not yet recruiting
23.06.2026
Germany Germany
Not yet recruiting
23.06.2026
Hungary Hungary
Not yet recruiting
23.06.2026
Italy Italy
Not yet recruiting
23.06.2026
Poland Poland
Not yet recruiting
23.06.2026
Portugal Portugal
Not yet recruiting
23.06.2026
Romania Romania
Not yet recruiting
23.06.2026
Spain Spain
Not yet recruiting
23.06.2026
Sweden Sweden
Not yet recruiting
23.06.2026
The Netherlands The Netherlands
Not yet recruiting
23.06.2026

Trial locations

Investigated drugs:

Itepekimab is a laboratory‑made protein given as a small injection under the skin. It works by blocking a part of the immune system that can cause swelling and growth of tissue in the nose. In this study, adults whose chronic sinus condition with nasal polyps was not well‑controlled received itepekimab to see if it remains safe and well‑tolerated when used for a long time. The medication is supplied as a clear liquid in a ready‑to‑use pre‑filled syringe.

Chronic rhinosinusitis with nasal polyps – Chronic rhinosinusitis with nasal polyps is a long‑lasting inflammation of the nasal passages and sinuses that includes the growth of soft tissue lumps called polyps. The condition causes swelling, blockage, and excess mucus in the nose and sinus cavities. Over time the polyps can become larger, making it harder to breathe through the nose and leading to a feeling of fullness in the face. The inflammation may flare up repeatedly, causing periods of increased congestion, runny nose, and reduced sense of smell. Symptoms often persist for months or years, and the condition can gradually worsen if the underlying inflammation continues.

Trial ID:
2025-522983-33-00
Protocol code:
LTS18420
Trial Phase:
Therapeutic confirmatory (Phase III)

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