| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Moderate to Severe Plaque Psoriasis |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 8.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10037153 |
| E.1.2 | Term | Psoriasis |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To compare the efficacy of CNTO 1275 to etanercept and evaluate the safety of CNTO 1275 and etanercept |
|
| E.2.2 | Secondary objectives of the trial |
| To evaluate the efficacy and safety of retreatment with CNTO 1275 |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
| The substudy is described in the C0743T12 study protocol. The substudy will not take place in Europe. |
|
| E.3 | Principal 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. |
|
| E.4 | Principal 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 lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
27. Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent)
28. Have been hospitalized in the past 3 years for asthma, ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or required more than 1 short-term (≤ 2 weeks) course of oral corticosteroids for asthma within the previous year
29. Have undergone allergy immunotherapy previously for prevention of anaphylactic reactions
30. Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an Ig product
31. Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
32. Are known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
33. Are participating in another trial using an investigational agent or procedure during participation in the trial |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The proportion of subjects who achieve a PASI 75 response at Week 12. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | Yes |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 40 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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