Moderate to Severe Plaque Psoriasis MedDRA version: 8.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Product Name: CNTO1275
Product Code: CNTO1275
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
Current Sponsor code: CNTO1275
Other descriptive name: Human Monoclonal Ant
Human Anti-IL-12 Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of admi
Sponsors
Centocor B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are 18 years of age or older at time of consent; may be men or women. 2. Have had a diagnosis of plaque-type psoriasis at least 6 months prior to first administration of study agent. 3. Have plaque-type psoriasis covering at least 10% of total BSA at screening and at the time of the first administration of study agent. 4. Have a PASI score of 12 or greater at screening and at the time of the first administration of study agent. 5. Have a PGA score of 3 or greater at screening and at the time of the first administration of study agent. 6. Are candidates for phototherapy or systemic treatment for psoriasis. 7. Have failed to respond to, or have a contraindication to, or are intolerant to cyclosporine, MTX or PUVA. 8. Subjects must be considered, in the opinion of the investigator, suitable candidates for etanercept therapy according to their country's approved etanercept product labeling. 9. Women of childbearing potential and all men must be using adequate birth control measures and must agree to continue to use such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study agent. 10. Able to adhere to the study visit schedule and other protocol requirements. 11. Capable of giving informed consent and the consent must be obtained prior to any study related procedures. 12. Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study. 13. Must agree not to receive a live virus or live bacterial vaccination during the trial or up to 12 months after the last injection. 14. Must agree not to receive a bacille Calmette-Guerin (BCG) vaccination during the trial or up to 12 months after the last injection. 15. Have screening laboratory test results within the following parameters: a) Hemoglobin = 10 g/dL; b) White blood cells = 3.5 x 10(9)/L; c) Neutrophils = 1.5 x 10(9)/L; d) Platelets = 100 x 10(9)/L; e) Serum creatinine < 1.5 mg/dL (or < 133 mmol/L); f) AST, ALT, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range for the laboratory conducting the test. 16. Are considered eligible according to the following TB screening criteria: a) Have no history of latent or active TB prior to screening. b) Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. c) Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent. d) Within 1 month prior to the first administration of study agent, either have a negative tuberculin skin test, as outlined in the protocol, or have a newly identified positive tuberculin skin test during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. e) Have a chest radiograph (both posterior-anterior and lateral views or as defined by site-specific requirements), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 yea
Exclusion criteria
Exclusion criteria: 1. Currently have nonplaque forms of psoriasis 2. Have current drug-induced psoriasis 3. Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study 4. Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to CNTO 1275 and ABT-874 5. Have used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer 6. Have used any biologic within 3 months prior to the first administration of study agent or within 5 times the half-life of the biologic prior to the first administration of study agent, whichever is longer 7. Have ever received natalizumab or other agents that target alpha-4-integrin 8. Have ever received etanercept 9. Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation) within 4 weeks of the first administration of study agent 10. Have used topical medications/treatments that could affect psoriasis or PASI evaluation ) within 2 weeks of the first administration of study agent 11. Have used any systemic immunosuppressants ) within 4 weeks of the first administration of study agent 12. Are currently receiving lithium, antimalarial agents, or intramuscular gold, or have received lithium, antimalarial agents, or intramuscular gold within 4 weeks of the first administration of study agent 13. Have received within 3 months prior to the first injection a live virus or bacterial vaccination. Subjects must agree not to receive a live virus or bacterial vaccination during the trial or up to 12 months after the last study agent injection 14. Have had a BCG vaccination within 12 months of screening. Subject must agree not to receive a BCG vaccination during the trial or up to 12 months after the last study agent injection 15. Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection , recurrent urinary tract infection, or open, draining, or infected skin wounds or ulcers 16. Have or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening 17. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening 18. Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB 19. Have or ever have had a nontuberculous mycobacterial infection or opportunistic infection 20. Have or have had a herpes zoster infection within 2 months of the first administration of study agent 21. Be known to be infected with HIV, hepatitis B, or hepatitis C 22. Have a history of known demyelinating diseases such as multiple sclerosis or optic neuritis 23. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease 24. Have a history of, or concurrent, CHF, including medically controlled, asymptomatic CHF 25. Have a transplanted organ (with exception of a corneal transplant > 3 months prior to the first administration of study agent) 26. Have a known history of lymphoproliferati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of CNTO 1275 to etanercept and evaluate the safety of CNTO 1275 and etanercept;Secondary Objective: To evaluate the efficacy and safety of retreatment with CNTO 1275;Primary end point(s): The proportion of subjects who achieve a PASI 75 response at Week 12. | — |
Countries
Austria, Finland, Germany, Netherlands, United Kingdom
Outcome results
None listed