PsoriasisPhase 2PSOR-003NCT00606450
Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis
A Phase 2 study testing CC-10004 in people with Psoriasis, run by Amgen at 31 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- CC-10004
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 1 Apr 2006to 1 May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
Germany15 sites
Celgene Clinical Site
Ausburg
Celgene Clinical Site
Berlin
Department of Dermatologie and Venerology
Dresden
Department of Dermatology and Venerology
Frankfurt am Main
Celgene Clinical Site
Hamburg
Celgene Clinical Site
Hansestadt Salzwedel
Celgene Clinical Site
Heidelberg
Celgene Clinical Site
Herborn
Celgene Clinical Site
Homburg
Celgene Clinical Site
Leipzig
Celgene Clinical Site
Mannheim
Celgene Clinical Site
Münster
Celgene Clinical Site
Schwerin
Celgene Clinical Site
Wiesbaden
Celgene Clinical Site
Würzburg
Canada11 sites
Ultranova Skincare
Barrie, Ontario, L4M 6L2
Division of Dermatology and Cutaneous Science
Edmonton, Alberta
Eastern Canada Cutaneous Research Associates
Halifax, Nova Scotia, B3H 1Z4
Dermatrials Research
Hamilton, Ontario, L8N 1V6
The Lynde Center for Dermatology
Markham, Ontario, L3P 7N8
Duronder C.P. Inc
Moncton, New Brunswick, E1C 8X3
Innovaderm
Montreal, Quebec, H2K 4L5
North Bay Dermatology Centre
North Bay, Ontario, P1B3Z7
Dr Yves Poulin
Québec, Quebec, G1V 4X7
Division of Dermatology
Vancouver, British Columbia
K. Papp Clinical Research
Waterloo, Ontario, L3P 7N8
Czechia5 sites
Department of Dermatology
Brno
Department of Dermatology
Hradec Králové
Department of Dermatovererology
Olomouc
Department of Dermatovererology
Prague
Depart of Dermatology
Ústí nad Labem
About this study
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
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.
- Conditions
- Psoriasis
- Being tested
- CC-10004, Placebo
- Keywords
- plaque psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-10004Drug
Also called Apremilast
20 mg CC-10004 taken 1 time per day for 12 weeks
CC-10004Drug
Also called Apremilast
20 mg of CC-10004 taken 2 times per day for 12 weeks
PlaceboDrug
matching placebo taken either 1 or 2 times per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 20 mg Apremilast daily | Experimental | 20 mg of CC-10004 daily Receives: Drug: CC-10004 |
| 20mg Apremilast twice daily | Experimental | CC-10004 twice daily Receives: Drug: CC-10004 |
| Placebo | Placebo comparator | Placebo arm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (2)
To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study start1 Apr 2006
- Primary completion1 Feb 2007
- Study completion1 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606450
- Sponsor's protocol ID
- CC-10004-PSOR-003
- Acronym
- PSOR-003
- Status last verified
- Apr 2020
- First submitted
- 22 Jan 2008
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23030767
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00606450
- Acronym / sponsor ID
- PSOR-003 / CC-10004-PSOR-003
- Conditions
- Psoriasis
- Keywords
- plaque psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 1 Feb 2007 (actual)
- Study completion
- 1 May 2007 (actual)
- First posted
- 4 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 mg Apremilast daily | Experimental | Drug: CC-1000420 mg of CC-10004 daily |
| 20mg Apremilast twice daily | Experimental | Drug: CC-10004CC-10004 twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-10004Also: Apremilast20 mg CC-10004 taken 1 time per day for 12 weeks | Drug | 20 mg Apremilast daily |
| CC-10004Also: Apremilast20 mg of CC-10004 taken 2 times per day for 12 weeks | Drug | 20mg Apremilast twice daily |
| Placebomatching placebo taken either 1 or 2 times per day for 12 weeks | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis
Time frame: 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.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Background: PubMed 23030767Papp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-10004 in people with Psoriasis, run by Amgen at 31 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany, Canada, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00606450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.