Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)

PHASE3CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

April 22, 2021

Primary Completion Date

April 12, 2023

Study Completion Date

April 12, 2023

Conditions
Nasal Polyps
Interventions
DRUG

Mepolizumab

Mepolizumab will be available as a clear to opalescent, colorless solution for SC injection in a single-use, safety syringe at a unit dose strength of 100 mg/milliliters (mL).

DRUG

Placebo

Placebo will be available as a clear to opalescent, colorless sterile solution for SC injection in a single-use, safety syringe

DRUG

Standard of care

Participants will continue to receive Standard of care as they are used to before entry in the study.

Trial Locations (61)

100191

GSK Investigational Site, Beijing

100730

GSK Investigational Site, Beijing

108840

GSK Investigational Site, Moscow

119991

GSK Investigational Site, Moscow

150003

GSK Investigational Site, Yaroslavl

190013

GSK Investigational Site, Saint Petersburg

194356

GSK Investigational Site, Saint Petersburg

196158

GSK Investigational Site, Saint Petersburg

197022

GSK Investigational Site, Saint Petersburg

200003

GSK Investigational Site, Shanghai

200030

GSK Investigational Site, Shanghai

210029

GSK Investigational Site, Nanjing

255036

GSK Investigational Site, Zibo

264000

GSK Investigational Site, Yantai

266061

GSK Investigational Site, Qingdao

300201

GSK Investigational Site, Taiyuan

361004

GSK Investigational Site, Xiamen

430022

GSK Investigational Site, Wuhan

430060

GSK Investigational Site, Wuhan

510000

GSK Investigational Site, Guangzhou

523326

GSK Investigational Site, Dongguan

528400

GSK Investigational Site, Zhongshan

570311

GSK Investigational Site, Haikou

610041

GSK Investigational Site, Chengdu

457-8511

GSK Investigational Site, Aichi

464-8547

GSK Investigational Site, Aichi

471-8513

GSK Investigational Site, Aichi

262-0015

GSK Investigational Site, Chiba

272-0143

GSK Investigational Site, Chiba

910-1193

GSK Investigational Site, Fukui

806-8501

GSK Investigational Site, Fukuoka

810-0001

GSK Investigational Site, Fukuoka

734-8551

GSK Investigational Site, Hiroshima

663-8501

GSK Investigational Site, Hyōgo

665-0827

GSK Investigational Site, Hyōgo

309-1793

GSK Investigational Site, Ibaraki

920-0293

GSK Investigational Site, Ishikawa

763-8502

GSK Investigational Site, Kagawa

890-0062

GSK Investigational Site, Kagoshima

211-8533

GSK Investigational Site, Kanagawa

232-0024

GSK Investigational Site, Kanagawa

250-8558

GSK Investigational Site, Kanagawa

860-0814

GSK Investigational Site, Kumamoto

600-8216

GSK Investigational Site, Kyoto

602-8026

GSK Investigational Site, Kyoto

514-8507

GSK Investigational Site, Mie

983-8512

GSK Investigational Site, Miyagi

395-8505

GSK Investigational Site, Nagano

940-2085

GSK Investigational Site, Niigata

701-0192

GSK Investigational Site, Okayama

565-0871

GSK Investigational Site, Osaka

569-8686

GSK Investigational Site, Osaka

570-8507

GSK Investigational Site, Osaka

583-8588

GSK Investigational Site, Osaka

113-8655

GSK Investigational Site, Tokyo

141-0001

GSK Investigational Site, Tokyo

142-8666

GSK Investigational Site, Tokyo

143-8541

GSK Investigational Site, Tokyo

153-8515

GSK Investigational Site, Tokyo

160-0023

GSK Investigational Site, Tokyo

162-8543

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

BioClinica, Inc.

INDUSTRY

collaborator

Signant Health

OTHER

lead

GlaxoSmithKline

INDUSTRY

NCT04607005 - Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS) | Biotech Hunter | Biotech Hunter