OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

August 1, 2014

Primary Completion Date

November 3, 2016

Study Completion Date

November 3, 2016

Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG

omalizumab

150mg omalizumab via sub-cutaneous injection once every 4 weeks

DRUG

omalizumab

300mg omalizumab via sub-cutaneous injection once every 4 weeks

Trial Locations (35)

1629

Novartis Investigative Site, Pilar

14050

Novartis Investigative Site, Tlalpan

45190

Novartis Investigative Site, Zapopan

8207257

Novartis Investigative Site, Santiago

8420383

Novartis Investigative Site, Santiago

S2000DBS

Novartis Investigative Site, Santa Fe

S2000CXH

Novartis Investigative Site, Rosario

C1125ABE

Novartis Investigative Site, Buenos Aires

A4400ERH

Novartis Investigative Site, Salta

40110-060

Novartis Investigative Site, Salvador

21941-913

Novartis Investigative Site, Rio de Janeiro

06454-010

Novartis Investigative Site, Alphaville / Barueri

09060-650

Novartis Investigative Site, Santo André

T5K 1X3

Novartis Investigative Site, Edmonton

V5Z 4E8

Novartis Investigative Site, Vancouver

V6H 3K2

Novartis Investigative Site, Vancouver

A1A 4Y3

Novartis Investigative Site, St. John's

A1C 2H5

Novartis Investigative Site, St. John's

B3J 3R4

Novartis Investigative Site, Halifax

L4M 6L2

Novartis Investigative Site, Barrie

L8N 3Z5

Novartis Investigative Site, Hamilton

L8S 1G5

Novartis Investigative Site, Hamilton

K7L 2V7

Novartis Investigative Site, Kingston

L3P 1A8

Novartis Investigative Site, Markham

K1Y 4G2

Novartis Investigative Site, Ottawa

K9J 5K2

Novartis Investigative Site, Peterborough

M4V 1R2

Novartis Investigative Site, Toronto

M5G 1E2

Novartis Investigative Site, Toronto

N2J 1C4

Novartis Investigative Site, Waterloo

N8X 2G1

Novartis Investigative Site, Windsor

GIV 4M6

Novartis Investigative Site, Québec

M4C 5M5

Novartis Investigative Site, Toronto

Unknown

Novartis Investigative Site, Santo Domingo

Novartis Investigative Site, Panama City

01015

Novartis Investigative Site, Guatemala City

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY