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

PHASE3TerminatedINTERVENTIONAL
Enrollment

293

Participants

Timeline

Start Date

November 25, 2019

Primary Completion Date

August 6, 2024

Study Completion Date

April 7, 2025

Conditions
Nasal PolyposisEosinophilic Chronic Rhinosinusitis
Interventions
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).~For OLE, Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses and every 8 weeks for the rest 5 doses. For the patients on Benralizumab treatment during double blind period, placebo will be dosed at the second dose during OLE."

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)."

Trial Locations (116)

110

Research Site, Taipei

114

Research Site, Taipei

235

Research Site, Taipei

333

Research Site, Taoyuan District

1033

Research Site, Budapest

1046

Research Site, Budapest

1200

Research Site, Brussels

1303

Research Site, Sofia

1606

Research Site, Sofia

2800

Research Site, Tatabánya

3000

Research Site, Leuven

3004

Research Site, Melbourne

4001

Research Site, Plovdiv

4029

Research Site, Herston

6163

Research Site, Spearwood

7400

Research Site, Kaposvár

8000

Research Site, Székesfehérvár

8600

Research Site, Siófok

9000

Research Site, Ghent

9024

Research Site, Győr

10002

Research Site, Taipei

10330

Research Site, Bangkok

10400

Research Site, Bangkok

10461

Research Site, The Bronx

10605

Research Site, White Plains

10700

Research Site, Bangkok

11217

Research Site, Taipei

13005

Research Site, Marseille

18017

Research Site, Bethlehem

21162

Research Site, White Marsh

23235

Research Site, Richmond

31059

Research Site, Toulouse

32605

Research Site, Gainesville

34147

Research Site, Bakırköy

35340

Research Site, Izmir

40002

Research Site, Khon Kaen

40220

Research Site, Louisville

44280

Research Site, Malatya

50200

Research Site, Chiang Mai

53228

Research Site, Milwaukee

56124

Research Site, Pisa

65000

Research Site, Phitsanulok

74136

Research Site, Tulsa

75070

Research Site, McKinney

76109

Research Site, Fort Worth

81501

Research Site, Grand Junction

84790

Research Site, St. George

88100

Research Site, Catanzaro

92647

Research Site, Huntington Beach

98225

Research Site, Bellingham

100000

Research Site, Hanoi

100044

Research Site, Beijing

100191

Research Site, Beijing

100730

Research Site, Beijing

130061

Research Site, Changchun

196158

Research Site, Saint Petersburg

200065

Research Site, Shanghai

200092

Research Site, Shanghai

210029

Research Site, Nanjing

250014

Research Site, Jinan

264000

Research Site, Yantai

266071

Research Site, Qingdao

300050

Research Site, Tianjin

310003

Research Site, Hangzhou

330006

Research Site, Nanchang

400042

Research Site, Chongqing

410008

Research Site, Changsha

410013

Research Site, Changsha

426061

Research Site, Izhevsk

430022

Research Site, Wuhan

440067

Research Site, Penza

510000

Research Site, Guangzhou

510180

Research Site, Guangzhou

528000

Research Site, Foshan

530021

Research Site, Nanning

610041

Research Site, Chengdu

610072

Research Site, Chengdu

700000

Research Site, Ho Chi Minh City

710004

Research Site, Xi'an

710061

Research Site, Xi'an

830054

Research Site, Ürümqi

2260000

Research Site, Quillota

3481349

Research Site, Talca

7500588

Research Site, Santiago

8150000

Research Site, Santiago

C1121 ABE

Research Site, Buenos Aires

C1414AIF

Research Site, Buenos Aires

C1425BEN

Research Site, Ciudad de Buenos Aire

B1646EBJ

Research Site, San Fernando

Unknown

Research Site, Changsha

00161

Research Site, Roma

00168

Research Site, Roma

262-0015

Research Site, Chiba

251-0052

Research Site, Fujisawa-shi

734-8551

Research Site, Hiroshima

272-0143

Research Site, Ichikawa-shi

395-8505

Research Site, Iida-shi

211-0063

Research Site, Kawasaki-shi

860-0814

Research Site, Kumamoto

153-0061

Research Site, Meguro-ku

153-8515

Research Site, Meguro-ku

105-8471

Research Site, Minatoku

570-0074

Research Site, Moriguchi-shi

940-2085

Research Site, Nagaoka-shi

540-0008

Research Site, Osaka

160-0017

Research Site, Shinjuku-ku

910-1193

Research Site, Yoshida-gun

85-231

Research Site, Bydgoszcz

82-300

Research Site, Elblag

31-513

Research Site, Krakow

20-552

Research Site, Lublin

05-830

Research Site, Nadarzyn

60-805

Research Site, Poznan

53-301

Research Site, Wroclaw

90-153

Research Site, Łodź

09100

Research Site, Aydin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY