Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis (PSOR-003)
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| ClinicalTrials.gov Identifier: NCT00606450 |
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Recruitment Status :
Completed
First Posted : February 4, 2008
Last Update Posted : April 24, 2020
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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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: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | April 1, 2006 |
| Actual Primary Completion Date : | February 1, 2007 |
| Actual Study Completion Date : | May 1, 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Psoriasis
Drug Information available for:
Apremilast
| Arm | Intervention/treatment |
|---|---|
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Experimental: 20 mg Apremilast daily
20 mg of CC-10004 daily
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Drug: CC-10004
20 mg CC-10004 taken 1 time per day for 12 weeks
Other Name: Apremilast |
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Experimental: 20mg Apremilast twice daily
CC-10004 twice daily
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Drug: CC-10004
20 mg of CC-10004 taken 2 times per day for 12 weeks
Other Name: Apremilast |
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Placebo Comparator: Placebo
Placebo arm
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Drug: Placebo
matching placebo taken either 1 or 2 times per day for 12 weeks |
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 [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606450
Locations
Show 31 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00606450 |
| Other Study ID Numbers: |
CC-10004-PSOR-003 |
| First Posted: | February 4, 2008 Key Record Dates |
| Last Update Posted: | April 24, 2020 |
| Last Verified: | April 2020 |
Keywords provided by Amgen:
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plaque psoriasis |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Thalidomide Apremilast Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Phosphodiesterase 4 Inhibitors |
Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |