Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

337

Participants

Timeline

Start Date

December 15, 2017

Primary Completion Date

May 11, 2018

Study Completion Date

October 20, 2018

Conditions
Seasonal Allergic Rhinitis
Interventions
DRUG

Omalizumab

Omalizumab were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.

DRUG

Placebo

Placebo were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.

Trial Locations (22)

2270082

Novartis Investigative Site, Kashiwa

2710077

Novartis Investigative Site, Matsudo

262-0015

Novartis Investigative Site, Chiba

272-0143

Novartis Investigative Site, Ichikawa

270-0034

Novartis Investigative Site, Matsudo

279-0012

Novartis Investigative Site, Urayasu

212-0027

Novartis Investigative Site, Kawasaki

216 0006

Novartis Investigative Site, Kawasaki

216-0002

Novartis Investigative Site, Kawasaki

Unknown

Novartis Investigative Site, Yokohama

Novartis Investigative Site, Shinjuku-ku

343-0031

Novartis Investigative Site, Koshigaya

116 0011

Novartis Investigative Site, Arakawa-ku

101-0063

Novartis Investigative Site, Chiyoda-ku

103 0027

Novartis Investigative Site, Chuo Ku

132-0014

Novartis Investigative Site, Edogawa-ku

125-0061

Novartis Investigative Site, Katsushika-ku

164-0012

Novartis Investigative Site, Nakano-ku

158-0097

Novartis Investigative Site, Setagaya-ku

160-0008

Novartis Investigative Site, Shinjuku Ku

160-0017

Novartis Investigative Site, Shinjuku-ku

170-0005

Novartis Investigative Site, Toshima-Ku

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY