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Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID) (ORCHID)

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ClinicalTrials.gov Identifier: NCT04157335
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 23, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 4, 2021
Actual Study Start Date  ICMJE November 25, 2019
Estimated Primary Completion Date September 29, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2021)
  • Nasal Polyp Burden [ Time Frame: Baseline and Week 56 ]
    Change from baseline in endoscopic total nasal polyp score (NPS).
  • Patient-reported Nasal Blockage (NB) [ Time Frame: Baseline and week 56 ]
    Change from baseline in mean nasal blockage score (NBS).
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Endoscopic total nasal polyp score [ Time Frame: Baseline and Week 56 ]
    Change in endoscopic total nasal polyp score (nasal polyp score range from 0 to 8, higher scores mean a worse outcome)
  • Nasal blockage score [ Time Frame: Baseline and week 56 ]
    Change in mean nasal blockage score (The severity of nasal blockage can be rated as 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe )
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2021)
  • Sense of Smell [ Time Frame: Week 56 ]
    Change from baseline in difficulty with sense of smell (DSS) score
  • Sinus Opacification by CT Scan [ Time Frame: Week 56 ]
    Change from baseline in Lund Mackay score
  • Disease specific health-related quality of life (HRQoL) [ Time Frame: Week 56 ]
    Change from baseline in SinoNasal Outcome Test (SNOT-22) score.
  • Nasal Polyp Surgery [ Time Frame: Week 56 ]
    Time to first nasal polyp surgery
  • Systemic corticosteroid (SCS) use [ Time Frame: Week 56 ]
    Time to first SCS course for NP
  • Symptoms associated with CRSwNP [ Time Frame: Week 56 ]
    Change from baseline in nasal symptom score(s)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Lund Mackay Score [ Time Frame: Baseline and week 56 ]
    Change in Lund Mackay Score (Lund Mackay Score range from 0 to 24, higher scores mean a worse outcome)
  • Nasal polyp surgery [ Time Frame: By week 56 ]
    Time to first nasal polyp surgery
  • Patients with surgery for nasal polyp [ Time Frame: By week 56 ]
    Proportion of patients with surgery for nasal polyp
  • SinoNasal Outcome Test (SNOT-22) score [ Time Frame: Baseline and week 56 ]
    Change in SinoNasal Outcome Test (SNOT-22) score (SNOT-22 can be rated via a 6-point scale (0- No Problem to 5- Problem as bad as it can be)
  • Patients with systemic corticosteroids use for nasal polyp [ Time Frame: By week 56 ]
    Proportion of patients with systemic corticosteroids use for nasal polyp
  • First systemic corticosteroids course for nasal polyp [ Time Frame: By week 56 ]
    Time to first systemic corticosteroids course for nasal polyp
  • Courses of systemic corticosteroids for nasal polyp [ Time Frame: By week 56 ]
    Number of courses of systemic corticosteroids for nasal polyp
  • Total systemic corticosteroids dose used [ Time Frame: By Week 56 ]
    Systemic corticosteroids use for relief of nasal symptoms
  • Total duration of systemic corticosteroids use for nasal polyp [ Time Frame: By Week 56 ]
    Systemic corticosteroids use for relief of nasal symptoms
  • Nasal symptom score(s) as captured in the daily diary [ Time Frame: Baseline and week 56 ]
    Change in nasal symptom score(s) as captured in the daily diary (severity of each symptom at its worst can be rated using a 4-point verbal rating scale (0-none to 3-severe) )
  • University of Pennsylvania Smell Identification Test (UPSIT) score [ Time Frame: Baseline and week 56 ]
    Change in University of Pennsylvania Smell Identification Test score (UPSIT scores are based on number of correctly identified odors (score range 0 to 40), higher scores mean a better outcome.)
  • Sinus severity score by quantitative CT analysis [ Time Frame: Baseline and week 56 ]
    Change in sinus severity score by Quantitative CT analysis (sinus severity score range from 0 to 100%, higher scores mean a worse outcome)
  • Zinreich score (modified LMS) [ Time Frame: Baseline and week 56 ]
    Change in Zinreich score (modified LMS) (Zinreich score range from 0-54, higher scores mean a worse outcome.)
  • Short Form 36-item Health survey, Version 2 (SF-36v2) [ Time Frame: Baseline and week 56 ]
    Change in Short Form 36-item Health survey, Version 2 (SF-36v2), Physical Component Score and Mental Component Score and domains (each item is scored 0-100, with higher scores meaning better outcomes)
  • Serum trough concentrations [ Time Frame: Week 0, 16, 24, 40, 56, 60, 68, 80. ]
    Summary of serum concentration of benralizumab
  • Anti-drug antibodies [ Time Frame: Week 0, 16, 24, 40, 56, 60, 68, 80. ]
    Incidence of anti-drug antibodies
Current Other Pre-specified Outcome Measures
 (submitted: May 12, 2021)
Assessment the safety and tolerability of benralizumab [ Time Frame: Week 56 ]
AEs, Vital signs, Clinical Laboratory and ECG
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
Official Title  ICMJE 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)
Brief Summary This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.
Detailed Description Approximately 275 patients will be randomized to receive benralizumab 30 mg SC or matching placebo. After enrolment, eligible patients will enter a 6-week screening/run in period. Patients who meet eligibility criteria will be randomised 1:1 at Week 0 (Day 0) to receive either placebo or benralizumab 30 mg SC every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48). An end of treatment visit will be conducted at Week 56.All patients who complete the 56-week DB treatment period on investigational product (IP) may be eligible to continue into around one year OLE, during which all patients will receive 8 doses of benralizumab 30 mg. Patients in Benra arm during DB period will receive one dummy dose. The last study visit will occur at 8 weeks after the last dose of IP (Week 112/FU). Patients who do not enter OLE, will have their last study visit at Week 56 (EoDB) for follow-up and without administration of IP.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nasal Polyposis
Intervention  ICMJE
  • Biological: Benralizumab 30 mg

    Benralizumab is 30 mg/ml solution for injection in accessorized pre-filled syringe, 1 ml fill volume.

    Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48).

  • Biological: Matched placebo

    Matching placebo solution for injection in accessorized pre-filled syringe. 1 ml fill volume.

    Matching placebo subcutaneously will be injected every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48).

Study Arms  ICMJE
  • Experimental: Benralizumab
    Benralizumab administered subcutaneously
    Intervention: Biological: Benralizumab 30 mg
  • Placebo Comparator: Placebo
    Placebo administered subcutaneously
    Intervention: Biological: Matched placebo
Publications * Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3:CD013513. doi: 10.1002/14651858.CD013513.pub3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2021)
276
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
148
Estimated Study Completion Date  ICMJE July 29, 2024
Estimated Primary Completion Date September 29, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Female or male patients aged 18 to 75 years inclusive
  2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
  3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
  4. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
  5. Ongoing symptoms for at least 12 weeks prior to enrolment
  6. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
  7. Bi-weekly mean NBS ≥ 1.5 at randomization
  8. SNOT-22 total score ≥ 20 at enrolment and randomization
  9. Documented physician-diagnosed asthma
  10. Blood eosinophil count of >2% or ≥150/μL at enrolment

Exclusion criteria:

  1. Any nasal and/or sinus surgery within 3 months prior to enrolment
  2. Patients with conditions that makes them non evaluable for the co-primary 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;
  3. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
  4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
  5. Receipt of any marketed or investigational biologic product within 6 months of enrolment
  6. Currently pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   China,   France,   Hungary,   Italy,   Japan,   Poland,   Russian Federation,   Sweden,   Taiwan,   Thailand,   Turkey,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04157335
Other Study ID Numbers  ICMJE D3252C00002
2021-000267-72 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luo Zhang, Prof. Dr. Beijing Tongren Hospital
PRS Account AstraZeneca
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP