Clincosm LogoSign in Get a demo

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

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04157335
Collaborator
(none)
276
Enrollment
142
Locations
2
Arms
69.5
Anticipated Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 25, 2019
Anticipated Primary Completion Date :
Nov 8, 2024
Anticipated Study Completion Date :
Sep 8, 2025

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Nasal Polyp Burden [Baseline and Week 56]

    Change from baseline in endoscopic total nasal polyp score (NPS).

  2. Patient-reported Nasal Blockage (NB) [Baseline and week 56]

    Change from baseline in mean nasal blockage score (NBS).

Secondary Outcome Measures

  1. Sense of Smell [Week 56]

    Change from baseline in difficulty with sense of smell (DSS) score

  2. Sinus Opacification by CT Scan [Week 56]

    Change from baseline in Lund Mackay score

  3. Disease specific health-related quality of life (HRQoL) [Week 56]

    Change from baseline in SinoNasal Outcome Test (SNOT-22) score.

  4. Nasal Polyp Surgery [Week 56]

    Time to first nasal polyp surgery

  5. Systemic corticosteroid (SCS) use [Week 56]

    Time to first SCS course for NP

  6. Symptoms associated with CRSwNP [Week 56]

    Change from baseline in nasal symptom score(s)

Other Outcome Measures

  1. Assessment the safety and tolerability of benralizumab [Week 56]

    AEs, Vital signs, Clinical Laboratory and ECG

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

  1. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results

  2. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.

  3. Receipt of any marketed or investigational biologic product within 6 months of enrolment

  4. Currently pregnant or breastfeeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Fresno California United States 93720
2 Research Site Huntington Beach California United States 92647
3 Research Site Stockton California United States 95207
4 Research Site Grand Junction Colorado United States 81501
5 Research Site Gainesville Florida United States 32605
6 Research Site Lake Mary Florida United States 32746
7 Research Site Anderson Indiana United States 46016
8 Research Site Kansas City Kansas United States 66160
9 Research Site Louisville Kentucky United States 40220
10 Research Site White Marsh Maryland United States 21162
11 Research Site Boston Massachusetts United States 02111
12 Research Site Missoula Montana United States 59808
13 Research Site Bronx New York United States 10461
14 Research Site White Plains New York United States 10605
15 Research Site Cleveland Ohio United States 44195
16 Research Site Tulsa Oklahoma United States 74136
17 Research Site Bethlehem Pennsylvania United States 18017
18 Research Site Philadelphia Pennsylvania United States 19107
19 Research Site Fort Worth Texas United States 76109
20 Research Site McKinney Texas United States 75070
21 Research Site Saint George Utah United States 84790
22 Research Site Richmond Virginia United States 23235
23 Research Site Bellingham Washington United States 98225
24 Research Site Milwaukee Wisconsin United States 53228
25 Research Site Buenos Aires Argentina C1121 ABE
26 Research Site Buenos Aires Argentina C1414AIF
27 Research Site Ciudad de Buenos Aire Argentina C1425BEN
28 Research Site San Fernando Argentina B1646EBJ
29 Research Site Herston Australia 4029
30 Research Site Melbourne Australia 3004
31 Research Site Spearwood Australia 6163
32 Research Site Bruxelles Belgium 1200
33 Research Site Gent Belgium 9000
34 Research Site Leuven Belgium 3000
35 Research Site Quillota Chile 2260000
36 Research Site Santiago Chile 7500588
37 Research Site Santiago Chile 8150000
38 Research Site Talca Chile 3465584
39 Research Site Beijing China 100044
40 Research Site Beijing China 100191
41 Research Site Beijing China 100730
42 Research Site Changchun China 130061
43 Research Site Changsha China 410008
44 Research Site Changsha China 410013
45 Research Site Changsha China
46 Research Site Chengdu China 610041
47 Research Site Chengdu China 610072
48 Research Site Chongqing China 400042
49 Research Site Foshan China 528000
50 Research Site Guangzhou China 510000
51 Research Site Guangzhou China 510180
52 Research Site Hangzhou China 310003
53 Research Site Jinan China 250014
54 Research Site Nanchang China 330006
55 Research Site Nanjing China 210029
56 Research Site Nanning China 530021
57 Research Site Qingdao China 266071
58 Research Site Shanghai China 200065
59 Research Site Shanghai China 200092
60 Research Site Tianjin China 300052
61 Research Site Urumqi China 830054
62 Research Site Wuhan China 430022
63 Research Site Xi'an China 710004
64 Research Site Xian China 710061
65 Research Site Yantai China 264000
66 Research Site Le Kremlin Bicetre France 94275
67 Research Site Lille France 59037
68 Research Site Marseille France 13005
69 Research Site Nantes CEDEX 1 France 44093
70 Research Site Toulouse CEDEX 09 France 31059
71 Research Site Budapest Hungary 1033
72 Research Site Budapest Hungary 1046
73 Research Site Gyöngyös Hungary 3200
74 Research Site Győr Hungary 9024
75 Research Site Kaposvár Hungary 7400
76 Research Site Siófok Hungary 8600
77 Research Site Szombathely Hungary 9700
78 Research Site Székesfehérvár Hungary 8000
79 Research Site Tatabánya Hungary 2800
80 Research Site Bologna Italy 40138
81 Research Site Catanzaro Italy 88100
82 Research Site Milano Italy 20156
83 Research Site Pisa Italy 56124
84 Research Site Roma Italy 00161
85 Research Site Roma Italy 00168
86 Research Site Varese Italy 21100
87 Research Site Chiba-shi Japan 262-0015
88 Research Site Fujisawa-shi Japan 251-0052
89 Research Site Hiroshima-shi Japan 734-8551
90 Research Site Ichikawa-shi Japan 272-0143
91 Research Site Iida-shi Japan 395-8505
92 Research Site Kawasaki-shi Japan 211-0063
93 Research Site Kumamoto-shi Japan 860-0814
94 Research Site Meguro-ku Japan 153-0061
95 Research Site Meguro-ku Japan 153-8515
96 Research Site Minato-ku Japan 105-8471
97 Research Site Moriguchi-shi Japan 570-0074
98 Research Site Nagaoka-shi Japan 940-2085
99 Research Site Osaka-shi Japan 540-0008
100 Research Site Shinjuku-ku Japan 160-0017
101 Research Site Yoshida-gun Japan 910-1193
102 Research Site Bydgoszcz Poland 85-231
103 Research Site Cieszyn Poland 43-400
104 Research Site Elbląg Poland 82-300
105 Research Site Katowice Poland 40-282
106 Research Site Lublin Poland 20-552
107 Research Site Nadarzyn Poland 05-830
108 Research Site Poznań Poland 60-537
109 Research Site Poznań Poland 60-805
110 Research Site Wrocław Poland 53-301
111 Research Site Zawadzkie Poland 47-120
112 Research Site Łodź Poland 90-153
113 Research Site Izhevsk Russian Federation 426061
114 Research Site Moscow Russian Federation 115522
115 Research Site Penza Russian Federation 440067
116 Research Site Saint-Petersburg Russian Federation 196158
117 Research Site Saratov Russian Federation 410028
118 Research Site Lund Sweden 221 85
119 Research Site Örebro Sweden 70185
120 Research Site Taipei City Taiwan 110
121 Research Site Taipei City Taiwan 11217
122 Research Site Taipei City Taiwan 114
123 Research Site Taipei Taiwan 10002
124 Research Site Taipei Taiwan 235
125 Research Site Taoyuan Taiwan 333
126 Research Site Bangkok Thailand 10330
127 Research Site Bangkok Thailand 10400
128 Research Site Bangkok Thailand 10700
129 Research Site Chiang Mai Thailand 50200
130 Research Site Khon Kaen Thailand 40002
131 Research Site Phitsanulok Thailand 65000
132 Research Site Ankara Turkey 06100
133 Research Site Aydin Turkey 09100
134 Research Site Bakirkoy Turkey 34147
135 Research Site Izmir Turkey 35340
136 Research Site Malatya Turkey 44280
137 Research Site Hanoi Vietnam 100000
138 Research Site Ho Chi Minh City Vietnam 70000
139 Research Site Ho Chi Minh Vietnam 700000
140 Research Site Ho Chi Minh Vietnam 700000
141 Research Site Hochiminh Vietnam 700000
142 Research Site Hochiminh Vietnam 70000

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Principal Investigator: Luo Zhang, Prof. Dr., Beijing Tongren Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT04157335
Other Study ID Numbers:
  • D3252C00002
  • 2021-000267-72
First Posted:
Nov 8, 2019
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Nasal Polyps
Benralizumab

Study Results

No Results Posted as of Aug 19, 2022