PSOR-003: Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00606450

Collaborator

(none)

260

Enrollment

Locations

Arms

Actual Duration (Months)

8.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is an unmet medical need for safe, effective oral therapy for moderate-to-severe psoriasis. CC-10004 will be evaluated in a controlled setting of a clinical study. The information obtained from the study will aid in the design of future clinical trials and to establish the safety and efficacy of CC-10004.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: CC-10004 Drug: CC-10004 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20 mg Apremilast daily 20 mg of CC-10004 daily	Drug: CC-10004 20 mg CC-10004 taken 1 time per day for 12 weeks Other Names: Apremilast
Experimental: 20mg Apremilast twice daily CC-10004 twice daily	Drug: CC-10004 20 mg of CC-10004 taken 2 times per day for 12 weeks Other Names: Apremilast
Placebo Comparator: Placebo Placebo arm	Drug: Placebo matching placebo taken either 1 or 2 times per day for 12 weeks

Arm

Intervention/Treatment

Experimental: 20 mg Apremilast daily

20 mg of CC-10004 daily

Drug: CC-10004

20 mg CC-10004 taken 1 time per day for 12 weeks

Other Names:

Apremilast

Experimental: 20mg Apremilast twice daily

CC-10004 twice daily

Drug: CC-10004

20 mg of CC-10004 taken 2 times per day for 12 weeks

Other Names:

Apremilast

Placebo Comparator: Placebo

Placebo arm

Drug: Placebo

matching placebo taken either 1 or 2 times per day for 12 weeks

Outcome Measures

Primary Outcome Measures

To compare the clinical efficacy of 2 oral doses of CC-10004 with placebo when taken for 12 weeks in subjects with moderate-to-severe plaque-type psoriasis [12 weeks]

Secondary Outcome Measures

To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis [12 weeks]
To evaluate the effects of CC-10004 compared to placebo on the quality of life in subjects with moderate-to-severe plaque-type psoriasis. [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must understand and voluntarily sign and informed consent form
Must be in good health as judged by the investigator
Must be able to adhere to the study visit schedule and other protocol requirements
Must have greater than or equal to a 6 month history of moderate-to-severe plaque-type psoriasis
Must have a Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and Body Surface Area (BSA) greater than or equal to 10%
Must meet specific laboratory criteria
Must be a candidate for photo/systemic therapy
Women of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

Must not have clinically significant underlying disease processes
Must not be pregnant or lactating females
Must not have any condition, including lab abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study
Must not have a history of active mycobacterium tuberculosis infection within 3 years prior to the screening visit
Must not have a history of incompletely treated active of latent mycobacterium tuberculosis infection
Must not have a know history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
Must not be an immigrant form a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit
Must not have current erythrodermic, guttate, or pustular psoriasis
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
Must not use topical therapy within 14 days of randomization
Must not use systemic therapy for psoriasis within 28 days of randomization
Must not use phototherapy within 28 days of randomization
Must not use adalimumab or infliximab within 3 months of randomization
Must not use etanercept or efalizumab within 56 days of randomization
Must not use alefacept within 6 months of randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Dermatology and Cutaneous Science	Edmonton	Alberta	Canada
2	Division of Dermatology	Vancouver	British Columbia	Canada
3	Duronder C.P. Inc	Moncton	New Brunswick	Canada	E1C 8X3
4	Eastern Canada Cutaneous Research Associates	Halifax	Nova Scotia	Canada	B3H 1Z4
5	Ultranova Skincare	Barrie	Ontario	Canada	L4M 6L2
6	Dermatrials Research	Hamilton	Ontario	Canada	L8N 1V6
7	The Lynde Center for Dermatology	Markham	Ontario	Canada	L3P 7N8
8	North Bay Dermatology Centre	North Bay	Ontario	Canada	P1B3Z7
9	K. Papp Clinical Research	Waterloo	Ontario	Canada	L3P 7N8
10	Innovaderm	Montreal	Quebec	Canada	H2K 4L5
11	Dr Yves Poulin	Quebec City	Quebec	Canada	G1V 4X7
12	Department of Dermatology	Brno		Czechia
13	Department of Dermatology	Hradec Kralove		Czechia
14	Department of Dermatovererology	Olomouc		Czechia
15	Department of Dermatovererology	Praha		Czechia
16	Depart of Dermatology	Usti nad Labem		Czechia
17	Celgene Clinical Site	Ausburg		Germany
18	Celgene Clinical Site	Berlin		Germany
19	Department of Dermatologie and Venerology	Dresden		Germany
20	Department of Dermatology and Venerology	Frankfurt Main		Germany
21	Celgene Clinical Site	Hamburg		Germany
22	Celgene Clinical Site	Heidelberg		Germany
23	Celgene Clinical Site	Herborn		Germany
24	Celgene Clinical Site	Homburg		Germany
25	Celgene Clinical Site	Leipzig		Germany
26	Celgene Clinical Site	Mannheim		Germany
27	Celgene Clinical Site	Munster		Germany
28	Celgene Clinical Site	Salzwedel		Germany
29	Celgene Clinical Site	Schwerin		Germany
30	Celgene Clinical Site	Wiesbaden		Germany
31	Celgene Clinical Site	Wurzburg		Germany