Moderate to severe plaque psoriasis
Conditions
Interventions
Product Name: CNTO 1275
Product Code: CNTO 1275
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available yet
CAS Number: ---
Current Sponsor code: CNTO 1275
Other descriptive nam
Human anti-IL-12 Mab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40 and-90
Pharmaceutical form of the placebo: Solution for injection
Route of administration o
Sponsors
Centocor B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be 18 years of age or older at time of consent; may be male or female. 2. Have had a diagnosis of plaque-type psoriasis at least 6 months prior to first administration of study agent (subjects with concurrent psoriatic arthritis [PsA] may be enrolled). 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. Be candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment). 6. Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) 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. 7. Able to adhere to the study visit schedule and other protocol requirements. 8. Capable of giving informed consent and the consent must be obtained prior to any study related procedures. 9. Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study. 10. Must agree not to receive a live virus or live bacterial vaccination during the study or up to 12 months after the last injection. 11. Must agree not to receive a BCG vaccination during the study or up to 12 months after the last injection. 12. Have screening laboratory test results within the following parameters: a. Hemoglobin = 10 g/dL b. White blood cells = 3.5 x 1.000.000.000/L c. Neutrophils = 1.5 x 1.000.000.000/L d. Platelets e 100 = 1.000.000.000/L e. Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
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, whichever is longer. 6. Have used any biologic within the previous 3 months or 5 times the half-life of the biologic, whichever is longer. 7. Have ever received natalizumab or other agents that target alpha-4-integrin. 8. Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first administration of study agent. 9. Have used topical medications/treatments that could affect psoriasis or PASI evaluation within 2 weeks of the first administration of study agent. 10. Have used any systemic immunosuppressants within 4 weeks of the first administration of study agent. 11. Are currently receiving lithium, antimalarials, or intramuscular gold or have received lithium, antimalarials, or intramuscular gold within 4 weeks of the first administration of study agent. 12. 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 study or up to 12 months after the last study agent injection. 13. Have had a BCG vaccination within 12 months of screening. Subject must agree not to receive a BCG vaccination during the study or up to 12 months after the last study agent injection. 14. Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers. 15. Have or have had a serious infection, or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening. 16. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening. 17. 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 or fibrosis. 18. Have or ever have had a nontuberculous mycobacterial infection or opportunistic infection. 19. Have or have had a herpes zoster infection within 2 months of the first administration of study agent. 20. Are known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C. 21. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease. 22. Have a transplanted organ (with exception of a corneal transplant > 3 months prior to the first administration of study agent). 23. Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy and safety of CNTO 1275 in the treatment of subjects with moderate to severe plaque psoriasis.;Secondary Objective: Secondary objectives are to: 1 Evaluate dosing interval adjustment in subjects who inadequately respond to their starting dose regimen and 2 Evaluate the impact of CNTO 1275 on quality of life.;Primary end point(s): The proportion of subjects who achieve = 75% improvement in PASI from baseline at Week 12. | — |
Countries
Austria, Germany, United Kingdom
Outcome results
None listed