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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

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.

Condition or disease Intervention/treatment Phase
Nasal Polyposis Biological: Benralizumab 30 mg Biological: Matched placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : September 29, 2023
Estimated Study Completion Date : July 29, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Benralizumab
Benralizumab administered subcutaneously
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).


Placebo Comparator: Placebo
Placebo administered subcutaneously
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).





Primary Outcome Measures :
  1. Nasal Polyp Burden [ Time Frame: Baseline and Week 56 ]
    Change from baseline in endoscopic total nasal polyp score (NPS).

  2. Patient-reported Nasal Blockage (NB) [ Time Frame: Baseline and week 56 ]
    Change from baseline in mean nasal blockage score (NBS).


Secondary Outcome Measures :
  1. Sense of Smell [ Time Frame: Week 56 ]
    Change from baseline in difficulty with sense of smell (DSS) score

  2. Sinus Opacification by CT Scan [ Time Frame: Week 56 ]
    Change from baseline in Lund Mackay score

  3. Disease specific health-related quality of life (HRQoL) [ Time Frame: Week 56 ]
    Change from baseline in SinoNasal Outcome Test (SNOT-22) score.

  4. Nasal Polyp Surgery [ Time Frame: Week 56 ]
    Time to first nasal polyp surgery

  5. Systemic corticosteroid (SCS) use [ Time Frame: Week 56 ]
    Time to first SCS course for NP

  6. Symptoms associated with CRSwNP [ Time Frame: Week 56 ]
    Change from baseline in nasal symptom score(s)


Other Outcome Measures:
  1. Assessment the safety and tolerability of benralizumab [ Time Frame: Week 56 ]
    AEs, Vital signs, Clinical Laboratory and ECG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157335


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Luo Zhang, Prof. Dr. Beijing Tongren Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04157335    
Other Study ID Numbers: D3252C00002
2021-000267-72 ( EudraCT Number )
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
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
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Benralizumab
Nasal Polyposis
Eosinophilic Chronic Rhinosinusitis with Nasal Polyposis
Nasal Polyps
Asthma
Additional relevant MeSH terms:
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Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Benralizumab
Anti-Asthmatic Agents
Respiratory System Agents