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

Psoriasis Clinical Trial

— PSOR-003  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606450
• Other study ID #: CC-10004-PSOR-003
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2006
• Est. completion date: May 1, 2007

Study information

• Verified date: April 2020
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: May 1, 2007
• Est. primary completion date: February 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CC-10004
20 mg CC-10004 taken 1 time per day for 12 weeks
• CC-10004
20 mg of CC-10004 taken 2 times per day for 12 weeks
• Placebo
matching placebo taken either 1 or 2 times per day for 12 weeks

Locations

Country	Name	City	State
Canada	Ultranova Skincare	Barrie	Ontario
Canada	Division of Dermatology and Cutaneous Science	Edmonton	Alberta
Canada	Eastern Canada Cutaneous Research Associates	Halifax	Nova Scotia
Canada	Dermatrials Research	Hamilton	Ontario
Canada	The Lynde Center for Dermatology	Markham	Ontario
Canada	Duronder C.P. Inc	Moncton	New Brunswick
Canada	Innovaderm	Montreal	Quebec
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	Dr Yves Poulin	Quebec City	Quebec
Canada	Division of Dermatology	Vancouver	British Columbia
Canada	K. Papp Clinical Research	Waterloo	Ontario
Czechia	Department of Dermatology	Brno
Czechia	Department of Dermatology	Hradec Kralove
Czechia	Department of Dermatovererology	Olomouc
Czechia	Department of Dermatovererology	Praha
Czechia	Depart of Dermatology	Usti nad Labem
Germany	Celgene Clinical Site	Ausburg
Germany	Celgene Clinical Site	Berlin
Germany	Department of Dermatologie and Venerology	Dresden
Germany	Department of Dermatology and Venerology	Frankfurt Main
Germany	Celgene Clinical Site	Hamburg
Germany	Celgene Clinical Site	Heidelberg
Germany	Celgene Clinical Site	Herborn
Germany	Celgene Clinical Site	Homburg
Germany	Celgene Clinical Site	Leipzig
Germany	Celgene Clinical Site	Mannheim
Germany	Celgene Clinical Site	Munster
Germany	Celgene Clinical Site	Salzwedel
Germany	Celgene Clinical Site	Schwerin
Germany	Celgene Clinical Site	Wiesbaden
Germany	Celgene Clinical Site	Wurzburg

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Canada,  Czechia,  Germany, 

References & Publications (1)

Papp KA, Kaufmann R, Thaçi D, Hu C, Sutherland D, Rohane P. Efficacy and safety of apremilast in subjects with moderate to severe plaque psoriasis: results from a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison study. J Eur Acad Dermatol Venereol. 2013 Mar;27(3):e376-83. doi: 10.1111/j.1468-3083.2012.04716.x. Epub 2012 Oct 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis		12 weeks
Secondary	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