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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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
University Multiprofile Hospital For Active Treatment Kaspela EOOD
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PlovdivBulgariaCompleted
Military Medical Academy - Mhat - Sofia
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SofiaBulgariaCompleted
MBAL Serdika Ltd.
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SofiyaBulgariaCompleted
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
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SofiyaBulgariaCompleted
Clinexpert Kft.
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Budapest IIIHungaryCompleted
Ujpesti Egeszsegugyi Nonprofit Kft.
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Budapest IVHungaryCompleted
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryCompleted
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryCompleted
Siofoki Korhaz-Rendelointezet
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SiofokHungaryCompleted
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
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SzekesfehervarHungaryCompleted
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
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TatabányaHungaryCompleted
Azienda Ospedaliera Universitaria Mater Domini
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CatanzaroItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyCompleted
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
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BydgoszczPolandCompleted
Promed P.Lach R.Glowacki Sp. j.
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CracowPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
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LodzPolandCompleted
Centrum Alergologii Sp. z o.o.
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LublinPolandCompleted
Centrum Sluchu I Mowy Sp. z o.o.
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NadarzynPolandCompleted
Roth Medica
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PoznanPolandCompleted
Michal Bogacki Dobrostan
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WroclawPolandCompleted

This page is information, not medical advice. Discuss any trial with your doctor.