TCTR20190820003Not yet recruitingPhase 3
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)
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 148
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Capable of giving signed informed consent
- •2. Subject must be 18 to 75 years of age
- •3. Patients with bilateral sinonasal polyps that, despite treatment with standard of care including a history of treatment with SCS (oral, parenteral) or prior surgery for NP have severity consistent with a need for surgery
- •4. CT Lund Mackay score for ethmoid ≥ maxillary as determined by the study Imaging Core lab
- •5. Blood eosinophil count > 5% or >2% and ≤ 5% as determined by central lab
- •6. Patients who are on INCS or leukotriene receptor antagonists (LTRAs), need to be at stable dose for at least 30 days prior to V1
- •7. Willingness to maintain all standard of care treatment for NP stable for the duration of the study
- •8. SNOT-22 total score ≥ 20 at enrolment (V1)
- •9. At least 8 days of evaluable daily diary data in the 14-day period prior to randomisation (baseline bi-weekly mean score collected from study Day -13 to study Day 0).
- •10. At randomisation, a bi-weekly mean NBS ≥ 1.5
- •11. SNOT-22 total score ≥ 20 at randomisation (V3)
- •12. For patients that are on INCS or LTRAs, at least 70% compliance with INCS or LTRAs during the run-in period based on daily diary
- •13. Patients with a minimum weight of 35 kg
- •14. Negative serum pregnancy test result at V1 and a negative urine pregnancy test at V2 and randomisation for female patients of childbearing potential
- •15. Women of childbearing potential (WOCBP) must use an effective form of birth control
- •16. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal
- •17. Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception
Exclusion Criteria
- •1. Patients who have undergone any nasal and/or sinus surgery within 3 months prior to V1
- •2. Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint
- •3. Clinically important comorbidities
- •4. Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, autoimmune, haematological, psychiatric, or major physical impairment that is not stable
- •5. Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalisation (>24hrs) for treatment of asthma within 4 weeks prior to V1
- •à¸¸6. History of anaphylaxis to any biologic therapy or vaccine
- •7. Known history of allergy or reaction to any component of the IP formulation
- •8. History of Guillain-Barré syndrome
- •9. A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy
- •10. Current malignancy, or history of malignancy
- •11. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, during screening/run-in period
- •12. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality
- •13. Chronic stable hepatitis B and C
- •14. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test
- •15. Infection requiring systemic antibiotics (Ab) or systemic Ab for the treatment of NP within 14 days prior to V1
- •16. Use of immunosuppressive medication
- •17. Receipt of any marketed or investigational biologic products
- •18. Previous receipt of benralizumab.
- •19. Receipt of immunoglobulin or blood products within 30 days prior to V1.
- •20. Receipt of live attenuated vaccines 30 days prior to the date of randomisation.
- •21. Receipt of any investigational drug within 30 days or 5 half-lives whichever is longer prior to randomisation.
- •22. Receipt of systemic corticosteroid within 4 weeks prior to V1, or a scheduled systemic corticosteroid treatment during the study period.
- •23. Receipt of herbal remedies or traditional Chinese medicines within 30 days prior to V1
- •24. Concurrent enrolment in another clinical drug interventional trial
- •25. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 times the upper limit of normal (ULN).
- •26. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- •27. Judgment by the investigator that the subject should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- •28. Previous randomisation in the present study.
- •29. Planned major surgical procedures or scheduled NP surgery at the time of the study enrolment and randomisation
- •30. Initiated or is being maintained on an aspirin desensitization regimen for the management of AERD at the time of study enrolment or during the run-in period.
- •31. History of alcohol or drug abuse within 12 months prior to V1, based on Investigator’s assessment
- •32. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating
Investigators
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