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

NCT00723528 | Completed Phase 3 Results

• 2 other identifiers: CR015166JNS009-JPN-02
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 27

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type psoriasis.

Conditions

Psoriasis

Keywords

Psoriasis; Ustekinumab; CNTO 1275

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score

  Percentage of participants with \>=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.

  Week 12

Secondary Outcomes (12)

• Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12

  Week 12

• Psoriasis Area and Severity Index (PASI) Score

  Week 64

• Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score

  Week 64

• Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score

  Week 64

• Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64

  Week 28, 40, 52 and 64

Study Arms (7)

Placebo (CP)

PLACEBO COMPARATOR

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: Placebo (CP)

Ustekinumab 45 mg (CP)

ACTIVE COMPARATOR

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 45 mg (CP)

Ustekinumab 90 mg (CP)

ACTIVE COMPARATOR

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: Ustekinumab 90 mg (CP)

Placebo A (After CP)

PLACEBO COMPARATOR

After the controlled period (that is \[i.e.\], 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 A (After CP)

Placebo B (After CP)

PLACEBO COMPARATOR

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: Placebo B (After CP)

Ustekinumab 45 mg (After CP)

ACTIVE COMPARATOR

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 45 mg (After CP)

Ustekinumab 90 mg (After CP)

ACTIVE COMPARATOR

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.

Drug: Ustekinumab 90 mg (After CP)

Interventions

Placebo (CP) DRUG

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).

Placebo (CP)

Ustekinumab 45 mg (CP) DRUG

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).

Ustekinumab 45 mg (CP)

Ustekinumab 90 mg (CP) DRUG

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).

Ustekinumab 90 mg (CP)

Placebo A (After CP) DRUG

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.

Placebo A (After CP)

Placebo B (After CP) DRUG

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.

Placebo B (After CP)

Ustekinumab 45 mg (After CP) DRUG

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.

Ustekinumab 45 mg (After CP)

Ustekinumab 90 mg (After CP) DRUG

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.

Ustekinumab 90 mg (After CP)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants diagnosed with psoriasis (psoriasis vulgaris and psoriatic arthritis) at least 6 months before registration
• Participants with plaque type psoriasis covering at least 10 percent of total body surface area at the time of informed consent and at registration
• Participants with a PASI score of greater than or equal to 12 at the time of informed consent and at registration
• Female participants of childbearing potential or males, whose partner can be pregnant, must agree that he/she will continuously take an appropriate contraceptive measure for 1 year from the day of informed consent to termination of the final investigational treatment; in the case of childbearing potential females, pregnancy test at screening must be negative
• Participants must agree not to receive Bacillus Calmette-Guérin (BCG) vaccination and live vaccine inoculation for 1 year after final treatment with the investigational product

You may not qualify if:

• Participants with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis
• Participants with a medical history of tuberculosis infection or suspected tuberculosis infection
• Participants with present or past history of chronic or recurrent infection (e.g., chronic or recurrent urinary tract infection or respiratory infection)
• Participants with a current serious infection (e.g., sepsis, hepatitis, pneumonia, or pyelonephritis) or those who experienced a serious infection within the 2 month period before registration and including participants who received intravenous administration of antibiotics or antiviral agents within the 2 month period before registration
• Participants with a current or past history of malignant tumors (except for basal cell carcinoma, intraepidermal squamous cell carcinoma in the skin and uterine cervical squamous cell carcinoma, whose treatment was completed and no sign suggesting a recurrence has been observed, and squamous cell carcinoma in the skin whose treatment was completed and no sign suggesting a recurrence has been observed in the past 5 years)

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (27)

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Asahikawa, Japan

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Chitose, Japan

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Chūō, Japan

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Fukuoka, Japan

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Fushimi, Japan

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Isehara, Japan

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Kanazawa, Japan

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Kurume, Japan

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Kyoto, Japan

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Maebashi, Japan

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Minato, Japan

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Morioka, Japan

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Nagasaki, Japan

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Nagoya, Japan

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Nankoku, Japan

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Nishinomiya, Japan

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Osaka, Japan

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Ōsaka-sayama, Japan

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Sagamihara, Japan

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Sapporo, Japan

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Sendai, Japan

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Shigenobu N/A, Japan

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Shimotsuke, Japan

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Shinjuku, Japan

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Suita, Japan

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Tokyo, Japan

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Tsu, Japan

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Related Links

• Week 28 data cut-off Clinical Study Report for a Placebo-Controlled Double-Blind Study of CNTO 1275 in Subjects with Plaque Psoriasis
• \|Final Clinical Study Report for A Placebo-Controlled Double-Blind Study of CNTO 1275 in Subjects with Plaque Psoriasi

MeSH Terms

Conditions

Psoriasis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Director, Clinical Development
• Organization: Janssen Research & Development, LLC

793-7633

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2010
• Last Updated: May 20, 2014
• Results First Posted: May 20, 2014

Record last verified: 2014-04

Locations

JP (27)