Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study) - Full Text View

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00773734

Purpose

The purpose of this study is to test if the study drug apremilast is safe, if it helps improve psoriasis, and how subjects tolerate it.

Condition	Intervention	Phase
Psoriasis Plaque-Type Psoriasis	Drug: Apremilast 10mg BID Drug: Apremilast 20mg BID Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Apremilast

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Proportion of subjects treated with oral apremilast who achieve a Psoriasis Area and Severity Index (PASI)-75 at Week 16 in reference to baseline [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Type, frequency, severity and relationship of adverse events to apremilast [ Time Frame: Approximately every 2 weeks ] [ Designated as safety issue: Yes ]
To evaluate the safety of 3 oral doses of apremilast in subjects with moderate-to-severe plaque-type psoriasis [ Time Frame: Approximately every 2 weeks ] [ Designated as safety issue: No ]
To evaluate the effects of 3 oral doses of apremilast on the quality of life in subjects with moderate-to-severe plaque-type psoriasis. [ Time Frame: Baseline, Weeks 16 and 24 ] [ Designated as safety issue: No ]
To determine a dose-response relationship in 3 oral doses of apremilast using percent reduction of PASI scores in subjects with moderate-to-severe plaque-type psoriasis [ Time Frame: Approximately every 2 weeks ] [ Designated as safety issue: No ]
To characterize the pharmacokinetics (PK) of apremilast in subjects with moderate-to-severe plaque-type psoriasis. [ Time Frame: Approximately every 2 weeks ] [ Designated as safety issue: No ]

Enrollment:	352
Study Start Date:	September 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Apremilast 10mg BID	Drug: Apremilast 10mg BID 10mg tablets Other Name: CC-10004
Active Comparator: Apremilast 20mg BID	Drug: Apremilast 20mg BID 20mg tablets Other Name: CC-10004
Active Comparator: Apremilast 30mg BID	Drug: Apremilast 10mg BID 10mg tablets Other Name: CC-10004 Drug: Apremilast 20mg BID 20mg tablets Other Name: CC-10004
Placebo Comparator: Placebo	Drug: Placebo Apremilast identically appearing placebo tablets Other Name: placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Understand and voluntarily sign an informed consent form
≥18 years of age at the time of signing the informed consent form
Able to adhere to the study visit schedule and other protocol requirements.
Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as defined by:
1. PASI score ≥ 12
2. BSA ≥ 10%
Candidate for photo/systemic therapy
In good health as judged by the investigator, based on medical history, physical examination, 12-lead ECG, serum chemistry, hematology, immunology, and urinalysis
Meet all laboratory criteria as defined per
Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception methods. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication
Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication

Exclusion Criteria:

History of clinically significant disease(as determined by the investigator)
Pregnant or breastfeeding
History of active mycobacterial infection within 3 years
History of Human Immunodeficiency Virus (HIV) infection
Congenital and acquired immunodeficiencies
Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
Antibodies to Hepatitis C at screening
Malignancy or history of malignancy except for treated [i.e., cured] basal-cell skin carcinomas
Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Psoriasis flare within 4 weeks of screening
Topical therapy within 2 weeks of randomization
Systemic therapy for psoriasis within 4 weeks of randomization
Use of phototherapy within 4 weeks of randomization (i.e., UVB, PUVA)
Adalimumab, etanercept, efalizumab or infliximab within 12 weeks of randomization
Alefacept within 24 weeks of randomization
Investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)
Prolonged sun exposure or use of tanning booths or other ultraviolet light sources

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773734

Show 35 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Robert Day, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Elliot Rosenstein, MD, Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00773734 History of Changes
Other Study ID Numbers:	CC-10004-PSOR-005
Study First Received:	October 14, 2008
Last Updated:	September 28, 2009
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Celgene Corporation:

moderate-to-severe plaque-type psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012