An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

PHASE3CompletedINTERVENTIONAL
Enrollment

177

Participants

Timeline

Start Date

September 29, 2015

Primary Completion Date

June 19, 2017

Study Completion Date

December 4, 2017

Conditions
AsthmaElevated Blood EosinophilsOral Corticosteroid Dependence
Interventions
DRUG

Reslizumab

Reslizumab 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

DRUG

Placebo

Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

DRUG

Non-Oral Corticosteroid (non-OCS) Asthma Medication

Participants continue using their non-OCS background asthma medications without change during the study's treatment period.

DRUG

Oral Corticosteroid (OCS)

After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.

Trial Locations (127)

1200

Teva Investigational Site 37059, Brussels

2000

Teva Investigational Site 20087, Rosario

2091

Teva Investigational Site 58251, Kyiv

2305

Teva Investigational Site 78091, New Lambton

3000

Teva Investigational Site 51233, Hatvan

3049

Teva Investigational Site 58237, Kyiv

3128

Teva Investigational Site 78092, Box Hill

3199

Teva Investigational Site 78097, Frankston

4275

Teva Investigational Site 32574, Leipzig

5030

Teva Investigational Site 37058, Gembloux

5042

Teva Investigational Site 78089, Bedford Park

5067

Teva Investigational Site 78093, Kent Town

5500

Teva Investigational Site 20055, Mendoza

6009

Teva Investigational Site 78090, Nedlands

7200

Teva Investigational Site 51232, Dombóvár

9300

Teva Investigational Site 51254, Csorna

9700

Teva Investigational Site 51253, Szombathely

10717

Teva Investigational Site 32576, Berlin

12159

Teva Investigational Site 32573, Berlin

13187

Teva Investigational Site 32578, Berlin

16132

Teva Investigational Site 30154, Genova

17004

Teva Investigational Site 31161, Girona

18057

Teva Investigational Site 32580, Rostock

21001

Teva Investigational Site 58246, Vinnytsia

22030

Teva Investigational Site 13358, Fairfax

29414

Teva Investigational Site 13366, Charleston

30173

Teva Investigational Site 32579, Hanover

31203

Teva Investigational Site 21106, Chihuahua City

33015

Teva Investigational Site 13344, Miami

33029

Teva Investigational Site 13354, Pembroke Pines

33030

Teva Investigational Site 13351, Homestead

33133

Teva Investigational Site 13372, Miami

33607

Teva Investigational Site 13346, Tampa

33870

Teva Investigational Site 13368, Sebring

34080

Teva Investigational Site 21104, Durango

34741

Teva Investigational Site 13342, Kissimmee

34769

Teva Investigational Site 13343, Saint Cloud

39531

Teva Investigational Site 13362, Biloxi

39617

Teva Investigational Site 58249, Kremenchuk

40022

Teva Investigational Site 58243, Sumy

44100

Teva Investigational Site 21094, Guadalajara

44130

Teva Investigational Site 21091, Guadalajara

44160

Teva Investigational Site 21100, Guadalajara

44220

Teva Investigational Site 21093, Guadalajara

44281

Teva Investigational Site 80091, Kfar Saba

45231

Teva Investigational Site 13349, Cincinnati

46017

Teva Investigational Site 31160, Valencia

46026

Teva Investigational Site 31158, Valencia

46360

Teva Investigational Site 13345, Michigan City

49044

Teva Investigational Site 58245, Dnipro

49074

Teva Investigational Site 58238, Dnipropetrovsk

49100

Teva Investigational Site 80084, Petah Tikva

59037

Teva Investigational Site 35185, Lille

60389

Teva Investigational Site 32622, Frankfurt

60612

Teva Investigational Site 13367, Chicago

61002

Teva Investigational Site 58244, Kharkiv

61007

Teva Investigational Site 58235, Kharkiv

61035

Teva Investigational Site 58239, Kharkiv

61039

Teva Investigational Site 58241, Kharkiv

61761

Teva Investigational Site 13363, Normal

63106

Teva Investigational Site 13350, St Louis

63143

Teva Investigational Site 13352, St Louis

64460

Teva Investigational Site 21103, Monterrey

64718

Teva Investigational Site 21101, Monterrey

66215

Teva Investigational Site 13348, Lenexa

67091

Teva Investigational Site 35187, Strasbourg

69035

Teva Investigational Site 58242, Zhaporizhzhya

69317

Teva Investigational Site 35189, Lyon

73034

Teva Investigational Site 13371, Clermont

Teva Investigational Site 13370, Edmond

73112

Teva Investigational Site 13347, Oklahoma City

75225

Teva Investigational Site 13377, Dallas

76018

Teva Investigational Site 58240, Ivano-Frankivsk

76100

Teva Investigational Site 80082, Rehovot

76800

Teva Investigational Site 21105, Querétaro

77099

Teva Investigational Site 13369, Houston

86825

Teva Investigational Site 32621, Bad Wörishofen

88100

Teva Investigational Site 30152, Catanzaro

90813

Teva Investigational Site 13365, Long Beach

91120

Teva Investigational Site 80083, Jerusalem

93301

Teva Investigational Site 13357, Bakersfield

129090

Teva Investigational Site 50384, Moscow

197089

Teva Investigational Site 50357, Saint Petersburg

454021

Teva Investigational Site 50417, Chelyabinsk

620039

Teva Investigational Site 50419, Yekaterinburg

630091

Teva Investigational Site 50383, Novosibirsk

630099

Teva Investigational Site 50386, Novosibirsk

634050

Teva Investigational Site 50418, Tomsk

634063

Teva Investigational Site 50358, Tomsk

650002

Teva Investigational Site 50385, Kemerovo

650099

Teva Investigational Site 50382, Kemerovo

656024

Teva Investigational Site 50356, Barnaul

3436212

Teva Investigational Site 80085, Haifa

10016-9196

Teva Investigational Site 13356, New York

C1028AAP

Teva Investigational Site 20059, Buenos Aires

C1425BEN

Teva Investigational Site 20058, Buenos Aires

C1426ABP

Teva Investigational Site 20056, Buenos Aires

Unknown

Teva Investigational Site 20057, Buenos Aires

Teva Investigational Site 20066, San Rafael

X5003DCE

Teva Investigational Site 20052, Córdoba

M5500CCG

Teva Investigational Site 20050, Mendoza

T4000CHE

Teva Investigational Site 20051, San Miguel de Tucumán

690 74

Teva Investigational Site 54133, Břeclav

377 38

Teva Investigational Site 54132, Jindřichův Hradec

94275 Cedex

Teva Investigational Site 35186, Le Kremlin-Bicêtre

07020

Teva Investigational Site 21102, Distrito Federal

06700

Teva Investigational Site 21090, Mexico City

8901 BR

Teva Investigational Site 38084, Leeuwarden

8025-AB

Teva Investigational Site 38085, Zwolle

80-952

Teva Investigational Site 53316, Gdansk

31-624

Teva Investigational Site 53318, Krakow

90-153

Teva Investigational Site 53319, Lodz

Teva Investigational Site 53321, Lodz

59-300

Teva Investigational Site 53322, Lubin

63-400

Teva Investigational Site 53320, Ostrów Wielkopolski

35-612

Teva Investigational Site 53358, Rzeszów

33-100

Teva Investigational Site 53317, Tarnów

54-239

Teva Investigational Site 53323, Wroclaw

411-706

Teva Investigational Site 87020, Goyang-si

561-712

Teva Investigational Site 87024, Jeonju

463-707

Teva Investigational Site 87025, Seongnam-si

137-701

Teva Investigational Site 87023, Seoul

138-736

Teva Investigational Site 87022, Seoul

143-729

Teva Investigational Site 87021, Seoul

?08025

Teva Investigational Site 31159, Barcelona

03680

Teva Investigational Site 58248, Kyiv

?03680

Teva Investigational Site 58250, Kyiv

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT02501629 - An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils | Biotech Hunter | Biotech Hunter