Long-term Safety Extension Study of Apremilast (CC-10004) in Subjects Who Completed the Treatment Phase of the Extension Study CC-10004-PSOR-005E (PSOR-005LTE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01130116
First received: May 24, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

The purpose of this long-term extension study is to assess the safety of dosing with apremilast for up to five years, to see if it continues to improve psoriasis, and how subjects tolerate it.


Condition Intervention Phase
Psoriasis
Drug: Apremilast
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: Long-term Safety Extension Study of Apremilast (CC-10004) in Subjects Who Completed the Treatment Phase of the Extension Study CC-10004-PSOR-005E

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Number of Patients with Adverse Events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Long-term safety (type, frequency, severity, and relationship of adverse events to apremilast)


Secondary Outcome Measures:
  • Long term Clinical Efficacy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Long-term clinical efficacy, as measured by Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Static Physician Global Assessment (sPGA), and Quality of Life


Estimated Enrollment: 56
Study Start Date: March 2010
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apremilast 20 mg
Apremilast 20mg cards dispensed for oral administration twice a day with corresponding placebo
Drug: Apremilast

Apremilast 20mg cards dispensed for oral administration twice a day with corresponding placebo

Apremilast 30mg cards dispensed for oral administration twice a day with corresponding placebo

Other Name: Apremilast
Experimental: Apremilast 30mg
Apremilast 30mg cards dispensed for oral administration twice a day with corresponding placebo
Drug: Apremilast

Apremilast 20mg cards dispensed for oral administration twice a day with corresponding placebo

Apremilast 30mg cards dispensed for oral administration twice a day with corresponding placebo

Other Name: Apremilast
Placebo Comparator: Placebo
Placebo to correspond with active comparators
Drug: Apremilast

Apremilast 20mg cards dispensed for oral administration twice a day with corresponding placebo

Apremilast 30mg cards dispensed for oral administration twice a day with corresponding placebo

Other Name: Apremilast

  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 document prior to any study related assessments/procedures being conducted.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Have completed the Week 28 assessments in the extension study and will enroll directly into the long-term extension study (i.e., the same day as the Week 28 visit in the extension study or within 7 days of completing the extension study [1-7 days since the last dose of study drug]).
  • Continue to be in acceptable health as judged by the Investigator.
  • Females of childbearing potential (FCBP) must continue to have a negative serum pregnancy test at the Baseline Visit (the Baseline Visit of the long-term extension study is equivalent to the Week 28 visit in the extension study). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception methods while on IP: oral, injectable, or implantable hormone contraception; tubal ligation; intrauterine device; barrier contraceptive with spermicide or vasectomized partner. A FCBP must agree to have a serum pregnancy test at Baseline and at each quarterly visit. In addition, during months when there is no site visit scheduled, a FCBP must agree to return to the study site monthly for a urine pregnancy test.
  • 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 a FCBP while on IP and for 28 days after taking the last dose of IP.

Exclusion Criteria:

  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Any condition that confounds the ability to interpret data from the study as judged by the Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130116

Locations
United States, California
Associates In Research Inc.
Fresno, California, United States, 93720
Dermatology Associates
Los Angeles, California, United States, 90045
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Missouri
Central Dermatology
St. Louis, Missouri, United States, 63117
United States, Texas
Modern Research Associates
Dallas, Texas, United States, 75231
United States, Washington
Dermatology Associates of Seattle
Seattle, Washington, United States, 98101
Canada, British Columbia
Dr. Lorne E. Albrecht
Surrey, British Columbia, Canada, V3R 6A7
Canada, Ontario
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B 3Z7
Dr. Michael Robern
Ottawa, Ontario, Canada, K2G 6E2
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada, N2J 1C4
XLR8 Research
Windsor, Ontario, Canada, N8W 1E6
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Irina Khanskaya, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01130116     History of Changes
Other Study ID Numbers: CC-10004-PSOR-005LTE
Study First Received: May 24, 2010
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada

Keywords provided by Celgene Corporation:
Plaque-type psoriasis
Psoriasis
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 July 20, 2014