NCT04157335CompletedPhase 3
A study to evaluate the efficacy and safety of repeating dose of benralizumab administered SC versus placebo in patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps.
A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo- Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps (ORCHID)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Feb 2025
Brief summary (registry, in English)
To evaluate the effect of benralizumab on nasal polyp burden (assessed by nasal endoscopy) and patient-reported nasal blockage (NB).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 21 Dec 2023
- Start date
- Oct 2021
- Lead sponsor
- AstraZeneca AB
- Diseases
- Asthma
- NCT number
- NCT04157335
- EU CT number
- 2023-507987-38-00
- EudraCT number
- 2021-000267-72
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 79
- 25 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any nasal and/or sinus surgery within 3 months prior to enrolment
- Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
Other illness
- Patients with conditions that makes them non evaluable for the coprimary efficacy endpoint including but not limited to: • Unilateral antrochoanal polyps • Nasal septal deviation that occludes at least one nostril • Current rhinitis medicamentosa • Allergic fungal rhinosinusitis or allergic fungal sinusitis;
Other
- Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
- Receipt of any marketed or investigational biologic product within 6 months of enrolment
- Currently pregnant or breastfeeding
Who the study is looking for
- Female or male patients aged 18 to 75 years inclusive
- Blood eosinophil count of >2% or ≥150/μL at enrolment
- Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
- History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
- Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
- Ongoing symptoms for at least 12 weeks prior to enrolment
- Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
- Bi-weekly mean NBS ≥ 1.5 at randomization
- SNOT-22 total score ≥ 20 at enrolment and randomization
- Documented physician-diagnosed asthma
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| University Multiprofile Hospital For Active Treatment Kaspela EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Military Medical Academy - Mhat - Sofia Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| MBAL Serdika Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| Ujpesti Egeszsegugyi Nonprofit Kft. Coordinator of this site? Confirm its status | Budapest IV | Hungary | Completed |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Completed |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Completed |
| Siofoki Korhaz-Rendelointezet Coordinator of this site? Confirm its status | Siofok | Hungary | Completed |
| Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Szekesfehervar | Hungary | Completed |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz Coordinator of this site? Confirm its status | Tatabánya | Hungary | Completed |
| Azienda Ospedaliera Universitaria Mater Domini Coordinator of this site? Confirm its status | Catanzaro | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Promed P.Lach R.Glowacki Sp. j. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Centrum Alergologii Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Centrum Sluchu I Mowy Sp. z o.o. Coordinator of this site? Confirm its status | Nadarzyn | Poland | Completed |
| Roth Medica Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Michal Bogacki Dobrostan Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.