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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CC-10004
CC-10004
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring plaque psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Dermatology and Cutaneous Science
  • Division of Dermatology
  • Duronder C.P. Inc
  • Eastern Canada Cutaneous Research Associates
  • Ultranova Skincare
  • Dermatrials Research
  • The Lynde Center for Dermatology
  • North Bay Dermatology Centre
  • K. Papp Clinical Research
  • Innovaderm
  • Dr Yves Poulin
  • Department of Dermatology
  • Department of Dermatology
  • Department of Dermatovererology
  • Department of Dermatovererology
  • Depart of Dermatology
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Department of Dermatologie and Venerology
  • Department of Dermatology and Venerology
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Celgene Clinical Site
  • Celgene Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

20 mg Apremilast daily

20mg Apremilast twice daily

Placebo

Arm Description

20 mg of CC-10004 daily

CC-10004 twice daily

Placebo arm

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2008
Last Updated
April 22, 2020
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00606450
Brief Title
Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2006 (Actual)
Primary Completion Date
February 1, 2007 (Actual)
Study Completion Date
May 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
plaque psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20 mg Apremilast daily
Arm Type
Experimental
Arm Description
20 mg of CC-10004 daily
Arm Title
20mg Apremilast twice daily
Arm Type
Experimental
Arm Description
CC-10004 twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm
Intervention Type
Drug
Intervention Name(s)
CC-10004
Other Intervention Name(s)
Apremilast
Intervention Description
20 mg CC-10004 taken 1 time per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CC-10004
Other Intervention Name(s)
Apremilast
Intervention Description
20 mg of CC-10004 taken 2 times per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo taken either 1 or 2 times per day for 12 weeks
Primary Outcome Measure Information:
Title
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis
Time Frame
12 weeks
Title
To evaluate the effects of CC-10004 compared to placebo on the quality of life in subjects with moderate-to-severe plaque-type psoriasis.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Division of Dermatology and Cutaneous Science
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Division of Dermatology
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Duronder C.P. Inc
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Eastern Canada Cutaneous Research Associates
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Z4
Country
Canada
Facility Name
Ultranova Skincare
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
Dermatrials Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
The Lynde Center for Dermatology
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 7N8
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B3Z7
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
L3P 7N8
Country
Canada
Facility Name
Innovaderm
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Dr Yves Poulin
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Department of Dermatology
City
Brno
Country
Czechia
Facility Name
Department of Dermatology
City
Hradec Kralove
Country
Czechia
Facility Name
Department of Dermatovererology
City
Olomouc
Country
Czechia
Facility Name
Department of Dermatovererology
City
Praha
Country
Czechia
Facility Name
Depart of Dermatology
City
Usti nad Labem
Country
Czechia
Facility Name
Celgene Clinical Site
City
Ausburg
Country
Germany
Facility Name
Celgene Clinical Site
City
Berlin
Country
Germany
Facility Name
Department of Dermatologie and Venerology
City
Dresden
Country
Germany
Facility Name
Department of Dermatology and Venerology
City
Frankfurt Main
Country
Germany
Facility Name
Celgene Clinical Site
City
Hamburg
Country
Germany
Facility Name
Celgene Clinical Site
City
Heidelberg
Country
Germany
Facility Name
Celgene Clinical Site
City
Herborn
Country
Germany
Facility Name
Celgene Clinical Site
City
Homburg
Country
Germany
Facility Name
Celgene Clinical Site
City
Leipzig
Country
Germany
Facility Name
Celgene Clinical Site
City
Mannheim
Country
Germany
Facility Name
Celgene Clinical Site
City
Munster
Country
Germany
Facility Name
Celgene Clinical Site
City
Salzwedel
Country
Germany
Facility Name
Celgene Clinical Site
City
Schwerin
Country
Germany
Facility Name
Celgene Clinical Site
City
Wiesbaden
Country
Germany
Facility Name
Celgene Clinical Site
City
Wurzburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23030767
Citation
Papp KA, Kaufmann R, Thaci 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.
Results Reference
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Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis

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