Moderate to severe plaque-type psoriasis
Conditions
Interventions
Product Name: CC-10004
Product Code: CC-10004
Pharmaceutical Form: Capsule*
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharm
Sponsors
Celgene Corporation, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;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 | — |
Countries
Czech Republic, Germany
Outcome results
None listed