NCT00606450

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2

Geographic Reach
3 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

January 22, 2008

Last Update Submit

April 22, 2020

Conditions

Psoriasis

Keywords

plaque psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (3)

20 mg Apremilast daily

EXPERIMENTAL

20 mg of CC-10004 daily

Drug: CC-10004

20mg Apremilast twice daily

EXPERIMENTAL

CC-10004 twice daily

Drug: CC-10004

Placebo

PLACEBO COMPARATOR

Placebo arm

Drug: Placebo

Interventions

CC-10004DRUG

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

Also known as: Apremilast
20 mg Apremilast daily
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Division of Dermatology and Cutaneous Science

Edmonton, Alberta, Canada

Location

Division of Dermatology

Vancouver, British Columbia, Canada

Location

Duronder C.P. Inc

Moncton, New Brunswick, E1C 8X3, Canada

Location

Eastern Canada Cutaneous Research Associates

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1V6, Canada

Location

The Lynde Center for Dermatology

Markham, Ontario, L3P 7N8, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B3Z7, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, L3P 7N8, Canada

Location

Innovaderm

Montreal, Quebec, H2K 4L5, Canada

Location

Dr Yves Poulin

Québec, Quebec, G1V 4X7, Canada

Location

Department of Dermatology

Brno, Czechia

Location

Department of Dermatology

Hradec Králové, Czechia

Location

Department of Dermatovererology

Olomouc, Czechia

Location

Department of Dermatovererology

Prague, Czechia

Location

Depart of Dermatology

Ústí nad Labem, Czechia

Location

Celgene Clinical Site

Ausburg, Germany

Location

Celgene Clinical Site

Berlin, Germany

Location

Department of Dermatologie and Venerology

Dresden, Germany

Location

Department of Dermatology and Venerology

Frankfurt am Main, Germany

Location

Celgene Clinical Site

Hamburg, Germany

Location

Celgene Clinical Site

Heidelberg, Germany

Location

Celgene Clinical Site

Herborn, Germany

Location

Celgene Clinical Site

Homburg, Germany

Location

Celgene Clinical Site

Leipzig, Germany

Location

Celgene Clinical Site

Mannheim, Germany

Location

Celgene Clinical Site

Münster, Germany

Location

Celgene Clinical Site

Salzwedel, Germany

Location

Celgene Clinical Site

Schwerin, Germany

Location

Celgene Clinical Site

Wiesbaden, Germany

Location

Celgene Clinical Site

Würzburg, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23030767BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 4, 2008

Study Start

April 1, 2006

Primary Completion

February 1, 2007

Study Completion

May 1, 2007

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

DE(15)CA(11)CZ(5)