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)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00953875

First received: July 17, 2009

Last updated: August 28, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 17, 2009

Last Updated Date

August 28, 2012

Start Date ^ICMJE

March 2009

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To evaluate the clinical safety of up to 48 weeks of therapy with 3 oral doses of apremilast (10 mg PO BID, 20 mg PO BID, and 30 mg PO BID) in subjects with moderate to severe plaque-type psoriasis who completed the treatment phase in the core study. [ Time Frame: Up to 48 Weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00953875 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

To evaluate the clinical efficacy of up to 48 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. [ Time Frame: Up to 48 Weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Apremilast 10mg
Apremilast 10mg administered orally twice daily with corresponding placebo

Intervention: Drug: Apremilast 10mg
Experimental: Apremilast 20mg
Apremilast 20mg administered orally twice daily with corresponding placebo

Intervention: Drug: Apremilast 20mg
Experimental: Apremilast 30mg
Apremilast 30mg administered orally twice daily with corresponding placebo

Intervention: Drug: Apremilast 30mg
Placebo Comparator: Placebo
Placebo
Interventions:
- Drug: Apremilast 10mg
- Drug: Apremilast 20mg
- Drug: Apremilast 30mg
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

209

Completion Date

June 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00953875

Other Study ID Numbers ^ICMJE

CC-10004-PSOR-005E

Has Data Monitoring Committee

Responsible Party

Celgene Corporation

Study Sponsor ^ICMJE

Celgene Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Douglas R Hough

Celgene Corporation

Information Provided By

Celgene Corporation

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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