Extension Study Of Apremilast To Evaluate Safety And Efficacy In Subjects With Psoriasis Who Completed The Treatment Phase Of The Core Study CC-10004-PSOR-005 - Full Text View

Purpose

The purpose of this extension study is to assess the safety of dosing with apremilast for an additional 28 weeks, for a total of up to one year from the beginning of the core study, to see if it helps improve psoriasis, and how subjects tolerate it.

Condition	Intervention	Phase
Psoriasis	Drug: Apremilast 10mg Drug: Apremilast 20mg Drug: Apremilast 30mg Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2b, Multicenter, Treatment-Arm Blind, Safety And Efficacy 32-Week Extension Study Of Apremilast (CC-10004) In Subjects Who Completed The Treatment Phase Of The Core Study CC-10004-PSOR-005

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Number of Participants with Adverse Events [ Time Frame: Up to 52 Weeks ] [ Designated as safety issue: Yes ]
To evaluate the clinical safety of up to 52 weeks of therapy with 3 oral doses of apremilast (10 mg orally twice daily, 20 mg orally twice daily, and 30 mg orally twice daily) in subjects with moderate to severe plaque-type psoriasis who completed the treatment

Secondary Outcome Measures:

To evaluate the clinical efficacy [ Time Frame: Up to 52 Weeks ] [ Designated as safety issue: No ]
To evaluate the clinical efficacy of up to 52 weeks of therapy with 3 oral doses of apremilast in subjects with moderate to severe plaque-type psoriasis who completed the treatment phase in the core study.

Enrollment:	209
Study Start Date:	March 2009
Study Completion Date:	June 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Apremilast 10mg Apremilast 10mg administered orally twice daily with corresponding placebo	Drug: Apremilast 10mg Apremilast 10mg administered orally twice daily with corresponding placebo Other Names: Apremilast CC-10004
Experimental: Apremilast 20mg Apremilast 20mg administered orally twice daily with corresponding placebo	Drug: Apremilast 20mg Apremilast 20mg administered orally twice daily with corresponding placebo Other Names: Apremilast CC-10004
Experimental: Apremilast 30mg Apremilast 30mg administered orally twice daily with corresponding placebo	Drug: Apremilast 30mg Apremilast 30mg administered orally twice daily with corresponding placebo Other Names: Apremilast CC-10004
Placebo Comparator: Placebo Placebo	Drug: Apremilast 10mg Apremilast 10mg administered orally twice daily with corresponding placebo Other Names: Apremilast CC-10004 Drug: Apremilast 20mg Apremilast 20mg administered orally twice daily with corresponding placebo Other Names: Apremilast CC-10004 Drug: Apremilast 30mg Apremilast 30mg administered orally twice daily with corresponding placebo Other Names: Apremilast CC-10004 Drug: Placebo Apremilast 10mg administered orally twice daily with corresponding placebo. Apremilast 20mg administered orally twice daily with corresponding placebo. Apremilast 30mg administered orally twice daily with corresponding placebo. 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 the informed consent form
Able to adhere to the study visit schedule and other protocol requirements
Completed the Treatment Phase in the core study and must agree to continue without interruption in the extension study
Completed the Week 24 (Final Treatment Visit) assessments in the core study
Continue to be in good health as judged by the investigator, based on physical examination, 12-lead Electrocardiography (ECG), serum chemistry, hematology, immunology, and urinalysis
Women of childbearing potential (WCBP) must continue to have a negative serum pregnancy test at the Baseline visit. In addition, sexually active WCBP must agree to use TWO of the following adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. A WCBP must agree to have a serum pregnancy test every 4 weeks for the duration of the study
Males (including those who have had a vasectomy) must continue to agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study drug and for 84 days after the last dose of study drug

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
Pregnant or breastfeeding
Any known major protocol violation in the core study
Clinically significant abnormality on the 12-lead ECG at the Baseline Visit (the Baseline Visit of the extension study is equivalent to the Week 24 Visit in the core study)
Any condition, including the presence of laboratory abnormalities, which 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
Demonstrated clinical evidence of an autoimmune syndrome, such as drug-induced lupus erythematosus or drug-induced vasculitis, as judged by the investigator
A flare of psoriasis (defined as a sudden intensification of plaque psoriasis requiring prescribed medical intervention), or a diagnosis of erythrodermic, guttate, or pustular psoriasis
A flare of psoriatic arthritis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953875

Show 32 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Douglas R Hough

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00953875 History of Changes
Other Study ID Numbers:	CC-10004-PSOR-005E
Study First Received:	July 17, 2009
Last Updated:	August 28, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Celgene Corporation:

Moderate-to-Severe Plaque-Type Psoriasis
Moderate Plaque Type Psoriasis
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 May 23, 2013

Extension Study Of Apremilast To Evaluate Safety And Efficacy In Subjects With Psoriasis Who Completed The Treatment Phase Of The Core Study CC-10004-PSOR-005 (PSOR-005E)