A Phase 3, Multicenter, Randomized, Double-blind, Placebo controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis - PHOENIX 2
- Conditions
- Moderate to severe plaque psoriasis
- Registration Number
- EUCTR2005-003530-17-AT
- Lead Sponsor
- Centocor B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
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 < 1.5 mg/dL (or < 133 µmol/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.
13. Be 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 Appendix C, 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), 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 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>1 Evaluate dosing interval adjustment in subjects who inadequately respond to their starting dose regimen and <br>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.
- Secondary Outcome Measures
Name Time Method