A Verification Study of CNTO 1275 in Patients With Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00723528
First received: July 24, 2008
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to assess the effectiveness and safety of CNTO 1275 in patients with moderate to severe plaque type psoriasis in subcutaneous administration of 45 and 90 mg at weeks 0 and 4 and then every 12 weeks, using placebo as a control.


Condition Intervention Phase
Psoriasis
Drug: CNTO 1275
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Placebo-controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • The proportion of patients who achieved >=75% improvement in Psoriasis Area and Severity Index (PASI) at Week 12. [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients judged as [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 003
Placebo s.c. at Weeks 0, 4
Drug: Placebo
s.c. at Weeks 0, 4
Drug: CNTO 1275
45 or 90 mg s.c. at Weeks 12, 16, 28, 40, 52
Experimental: 001
CNTO 1275 45 or 90 mg s.c. at Weeks 12, 16, 28, 40, 52
Drug: CNTO 1275
45 mg s.c. at Weeks 0, 4, 16, 28, 40, 52
Experimental: 002
CNTO 1275 45 mg s.c. at Weeks 0, 4, 16, 28, 40, 52
Drug: CNTO 1275
90 mg s.c. at Weeks 0, 4, 16, 28, 40, 52

Detailed Description:

This is a multicenter, randomized (patients assigned study drug by chance), double-blind (neither the patient nor the physician knows the assigned medication name), placebo-controlled, parallel-group comparison study. This study has been planned to examine the effectiveness and safety of CNTO 1275 in Japanese patients with moderate to severe plaque type psoriasis in subcutaneous administration of the drug using placebo as a control. In the study, a clinical dose of the drug will be determined based on the obtained effectiveness and safety and it will be confirmed that similar therapeutic effect and safety can be obtained in this study compared to other phase III studies.

The patients will be randomly assigned to one of three treatment groups. Since the double-blind method is employed in this study, two prefilled syringes per dosing will be subcutaneously administered to patients during the treatment period. At 12 weeks and later in the active-drug treatment period, CNTO 1275 will be administered to all patients.

[Placebo-controlled treatment period <Weeks 0-12>]: 45-mg group: subcutaneous (s.c.) treatment with CNTO 1275 45 mg (0.5 mL) and placebo (1.0 mL) at Weeks 0 and 4. 90-mg group: s.c. treatment with CNTO 1275 90 mg (1.0 mL) and placebo (0.5 mL)at Weeks 0 and 4.

[Active-drug treatment period <Weeks 12-64>]: 45-mg group: s.c. treatment with placebo (0.5 mL and 1.0 mL) at Week 12, followed by s.c. treatment with CNTO 1275 45 mg (0.5 mL) and placebo (1.0 mL) at Week 16. Subsequently, s.c. treatment with CNTO 1275 45 mg (0.5 mL) and placebo (1.0 mL) every 12 weeks up to Week 52. 90-mg group: s.c. treatment with placebo (0.5 mL and 1.0 mL) at Week 12, followed by s.c. treatment with CNTO 1275 90 mg (1.0 mL) and placebo (0.5 mL) at Week 16. Subsequently, s.c. treatment with CNTO 1275 90 mg (1.0 mL) and placebo (0.5 mL) every 12 weeks up to Week 52.

Placebo group: At Weeks 12 and 16, s.c. treatment with CNTO 1275 and placebo in patients divided into the following 2 groups. Subsequently, s.c. treatment with CNTO 1275 at the same dose and placebo every 12 weeks up to Week 52.

Placebo group A: CNTO 1275 45 mg (0.5 mL) and placebo (1.0 mL). Placebo group B: CNTO 1275 90 mg (1.0 mL) and placebo (0.5 mL). The sorting to the Placebo group A or Placebo group B will be already determined at the time of allocation conducted at registration.

In addition the pharmacokinetics (including the measurement of serum anti-CNTO 1275 antibodies) will be assessed.

The investigator will handle any untoward medical event (including abnormal changes in laboratory data) that occurred in patients from after informed consent to the end of follow-up period as an adverse event, and conduct the safety assessment.

The information of adverse events (any untoward medical event that occurs in subjects administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product), adverse reactions any deleterious and unintended reactions (including laboratory test abnormalities) and injection site reaction]will be collected for safety assessments. Placebo (PLA)-controlled period: 1) CNTO 45 mg: CNTO 45 mg (0.5mL) + PLA (1.0ml), 2) CNTO 90 mg: CNTO 90 mg (1.0mL) + PLA (0.5ml), 3) PLA: PLA (0.5 and 1.0 ml) Active period:1) CNTO 45 mg: PLA (0.5 + 1.0mL) at Week 12, CNTO 45 mg at Week16, CNTO 45 mg + PLA (1.0) every 12 weeks up to 52 weeks, 2)CNTO 90 mg: PLA(0.5+1.0mL) at Week12, CNTO 95 mg at Week16, CNTO 90 mg + PLA (1.0) every 12 weeks up to 52 weeks, 3) PLA-a: CNTO 45 mg + PLA (1.0ml), 4) PLA-b: CNTO 90 mg + PLA (0.5ml).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with psoriasis (psoriasis vulgaris and psoriatic arthritis) at least 6 months before the subject registration
  • Patients with plaque type psoriasis covering at least 10% of total body surface area (BSA) at the time of informed consent and at registration
  • Patients with a PASI score of >=12 at the time of informed consent and at registration
  • If the patients are females of childbearing potential or males whose partner can be pregnant, the patients must agree that he/she will continuously take an appropriate contraceptive measure such as condoms and oral contraceptives for 1 year from the day of informed consent for 1 year to termination of the final investigational treatment. In the case of females who can be pregnant, the result of pregnancy test at screening must be negative.

Exclusion Criteria:

  • Patients with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis
  • Patients with a medical history of tuberculosis infection, or with suspected of tuberculosis infection
  • Patients with present illness of chronic or recurrent infection (e.g., chronic or recurrent urinary tract infection or respiratory infection) or a past history of this
  • Patients with a present illness of serious infection (e.g., sepsis, hepatitis, pneumonia or pyelonephritis) or those who experienced the serious infection within 2 months before registration. This includes patients with experience of intravenous administration of antibiotics or antiviral agents for infection within 2 months before registration
  • Patients with a present illness of malignant tumors or a past history of them (except for basal cell carcinoma, intraepidermal squamous cell carcinoma in the skin and squamous cell carcinoma of the cervix, 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723528

Locations
Japan
Asahikawa N/A, Japan
Bunkyo, Japan
Chitose, Japan
Chiyoda, Japan
Chuo, Japan
Fukuoka, Japan
Fukuoka N/A, Japan
Fushimi, Japan
Isehara, Japan
Itabashi-Ku, Japan
Kanazawa, Japan
Kanazawa N/A, Japan
Kurume, Japan
Kyoto, Japan
Kyoto N/A, Japan
Maebashi N/A, Japan
Minato, Japan
Morioka, Japan
Nagasaki, Japan
Nagoya, Japan
Nagoya N/A, Japan
Nangoku, Japan
Nishinomiya, Japan
Osaka, Japan
Osaka-Sayama, Japan
Osaka-Sayama N/A, Japan
Sagamihara, Japan
Sapporo, Japan
Sendai, Japan
Shigenobu N/A, Japan
Shimotsuke, Japan
Shinjuku, Japan
Suita N/A, Japan
Tokyo, Japan
Tokyo N/A, Japan
Tsu, Japan
Tsu N/A, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00723528     History of Changes
Other Study ID Numbers: CR015166, JNS009-JPN-02
Study First Received: July 24, 2008
Last Updated: August 27, 2012
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by Janssen Pharmaceutical K.K.:
Psoriasis
Plaque type psoriasis
Monoclonal antibody
IL-12
IL-23
Subcutaneous

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 23, 2014