E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque-type psoriasis |
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MedDRA Classification |
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 clinical efficacy of 2 oral (PO) doses of CC-10004 (20 mg once daily (QD) and 20 mg twice daily (BID)) with placebo when taken for 12 weeks in subjects with moderate-to-severe plaque-type psoriasis |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of CC-10004 (20 mg QD and 20 mg BID PO) compared with placebo in subjects with moderate-to-severe plaque-type psoriasis
To evaluate the effects of CC-10004 (20 mg QD and 20 mg BID PO) compared with placebo on the quality of life in subjects with moderate-to-severe plaque-type psoriasis |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Must understand and voluntarily sign an informed consent form 2. Must be a male or female of any ethnic origin or race, aged 18 years or older at time of consent 3. Must be in good health as judged by the investigator, based on medical history, physical examination, 12-lead ECG, serum chemistry, hematology, and urinalysis 4. Must be able to adhere to the study visit schedule and other protocol requirements 5. Must have a ≥6-month history of moderate-to-severe plaque-type psoriasis immediately prior to enrollment. Note that the severity must have been moderate-to-severe during the entire 6-month period before screening 6. Must have a PASI score ≥10 and BSA ≥10% 7. Must meet the following laboratory criteria: a. White blood cell count ≥3000/mm3 (≥3.0 X 10^9/L) and < 20,000/mm3 (<20 X 10^9/L) b. Platelet count ≥100,000/μL (≥100 X 10^9/L) c. Serum creatinine ≤1.5 mg/dl (≤132.6 μmol/L) d. AST (SGOT) and ALT (SGPT) ≤1.5 X upper limit of normal (ULN) 8. Must be a candidate for photo/systemic therapy (a subject is considered a candidate for photo/systemic therapy if in the judgment of a clinician the subject requires any systemic therapy, e.g., ultraviolet light A [UVA], ultraviolet light B [UVB], psoralens and long-wave ultraviolet radiation [PUVA], cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, or biological agents to control psoriasis whether or not that subject has a history of receiving systemic therapy). 9. Women of childbearing potential (WCBP)* must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active WCBP must agree to use two of the following adequate forms of contraception methods such as: oral, injectable or implantable hormonal contraception; tubal ligation; intrauterine device; barrier contraceptive with spermicide or vasectomized partner while on study. A WCBP must agree to have pregnancy tests every 4 weeks while on study medication. 10. Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study medication and for 4 weeks after taking the last dose of study medication
*A woman of child bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., women who have had menses at any time in the preceding 24 consecutive months)
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E.4 | Principal exclusion criteria |
1. Must not have a history of clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease 2. Must not be pregnant or lactating females 3. Must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study 4. Must not have a history of active mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit 5. Must not have a history of incompletely treated active or latent mycobacterium tuberculosis (any subspecies) infection 6. Must not have a known history of exposure to an infectious case (smear-positive) of mycobacterium tuberculosis within 2 years prior to the screening visit 7. Must not be an immigrant from a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit (see Appendix 21.7 for a listing of countries at high risk for mycobacterium tuberculosis disease) 8. Must not have current erythrodermic, guttate, or pustular psoriasis 9. Must not have a clinical history of failure to adequately respond to treatment in the investigator’s opinion to one or more treatment courses of cyclosporine or the following biologic therapies: alefacept, etanercept, efalizumab, infliximab or adalimumab 10. Must not use topical therapy (including but not limited to topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin) within 14 days of randomization. (Exception: moderate-to-low potency corticosteroids will be allowed for treatment of the palms, face, plantar surfaces, axillae and groin in accordance with the manufacturers suggested usage during the course of the study) 11. Must not use systemic therapy for psoriasis (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, fumaric acid esters) within 28 days of randomization 12. Must not use phototherapy (UVA, UVB, PUVA) within 28 days of randomization 13. Must not use adalimumab or infliximab within 3 months of randomization 14. Must not use etanercept or efalizumab within 56 days of randomization 15. Must not use alefacept within 6 months of randomization 16. Must not use any investigational drug within 30 days of randomization 19. Must not have a clinically significant abnormality on 12-lead ECG at screening 20. No known HIV, Hepatitis B or Hepatitis C infection 21. Must not have a history of malignancy within 5 years prior to the screening visit (except basal cell carcinoma or < 3 squamous-cell carcinomas of the skin) 22. Must not have evidence of skin conditions that would interfere with evaluations of the effect of study medication on psoriasis
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects treated with CC-10004 (20 mg QD and 20 mg BID PO) who achieve a Psoriasis Area and Severity Index reduction of 75% (PASI-75) at Day 84 (Week 12/Final Visit) in reference to the baseline visit compared with placebo |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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 | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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 |
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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
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The end of trial is the last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |