A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Comparison Study of CC-10004 in Subjects with Moderate-to-severe Plaque-Type Psoriasis

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2006-000057-22-DE
• Date of registration: 07/03/2006
• Prospective Registration: Yes
• Primary sponsor: Celgene Corporation, Inc.
• Public title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Comparison Study of CC-10004 in Subjects with Moderate-to-severe Plaque-Type Psoriasis
• Scientific title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Comparison Study of CC-10004 in Subjects with Moderate-to-severe Plaque-Type Psoriasis
• Date of first enrolment: 08/06/2006
• Target sample size: 255
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000057-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Germany

Key inclusion & exclusion 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 < 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)








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

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Moderate to severe plaque-type psoriasis

Intervention(s)

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-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

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

Secondary ID(s)

CC-10004-PSOR-003