An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis

PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

March 31, 2010

Conditions
Psoriasis
Interventions
DRUG

Placebo (CP)

Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).

DRUG

Ustekinumab 45 mg (CP)

Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).

DRUG

Ustekinumab 90 mg (CP)

Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).

DRUG

Placebo A (After CP)

After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.

DRUG

Placebo B (After CP)

After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.

DRUG

Ustekinumab 45 mg (After CP)

After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.

DRUG

Ustekinumab 90 mg (After CP)

After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.

Trial Locations (27)

Unknown

Asahikawa

Chitose

Chūō

Fukuoka

Fushimi

Isehara

Kanazawa

Kurume

Kyoto

Maebashi

Minato

Morioka

Nagasaki

Nagoya

Nankoku

Nishinomiya

Osaka

Ōsaka-sayama

Sagamihara

Sapporo

Sendai

Shigenobu N/A

Shimotsuke

Shinjuku

Suita

Tokyo

Tsu

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY