Clinical trial NCT02329223: Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite H1 Antihistamine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Spontaneous Uriticaria
Keywords: Chronic spontaneous uriticaria
Omalizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-12-31
Enrollment: 218
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
* Chronic spontaneous urticaria diagnosis for 6 months

Key Exclusion Criteria:

* Weight less than 20 kg
* Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
* Evidence of parasitic infection
* Any other skin diseases than chronic spontaneous urticaria with chronic itching
* Previous treatment with omalizumab
* Contraindications to diphenhydramine
* History of anaphylactic shock
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
* History of hypersensitivity to omalizumab or to drugs of similar chemical classes
* Pregnant or nursing (lactating) women

Primary outcomes:
measure: Change From Baseline in the Weekly Itch Severity Score at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in the Weekly Number of Hives Score at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
timeFrame: Week 12
measure: Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12
timeFrame: Week 12
measure: Percentage of Complete Responders (UAS7 = 0) at Week 12
timeFrame: Week 12
measure: Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Production of Anti-omalizumab Antibody
timeFrame: Week 24
Other outcomes:
Locations:
city: Toyoake-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Hiroshima-city
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Hitachi-city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Takamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokosuka-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kamimashi-gun
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Nagano-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sakai-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Saitama-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Izumo-city
country: Japan
facility: Novartis Investigative Site
state: Shimane
city: Kodaira-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Machida-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kofu-city
country: Japan
facility: Novartis Investigative Site
state: Yamanashi
city: Wonju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon
city: Hwaseong-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
References: