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: April 11, 2014
Last verified: December 2013
  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: Identical Matching Placebo at the 10mg, 20mg and 30mg BID dose
Phase 2

Study Type: Interventional
Study Design: Allocation: 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:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Safety (type, frequency, severity, and relationship of adverse events to apremilast) [ Time Frame: From informed consent to end of study ] [ Designated as safety issue: Yes ]
    Summary of Participants with Treatment-Emergent Adverse Events (TEAEs) from informed consent to end of study


Secondary Outcome Measures:
  • Proportion of subjects treated with oral apremilast who achieve PASI-75 at Week 28 of the extension study in reference to baseline of the core study [ Time Frame: From Baseline to Week 28 ] [ Designated as safety issue: No ]

    Proportion of subjects treated with oral apremilast who achieve PASI-75 at Week 28 of the extension study in reference to baseline of the core study

    • Equals 52 weeks total dosing with apremilast for subjects randomized to apremilast at Week 0 in the core study
    • Equals 36 weeks total dosing with apremilast for placebo/apremilast subjects

  • Proportion of placebo/apremilast subjects treated with oral apremilast who achieve, PASI-75 [ Time Frame: From Baseline of the core study to week 16 and 24 ] [ Designated as safety issue: No ]
    Proportion of placebo/apremilast subjects treated with oral apremilast who achieve, PASI-75 at Weeks 8 and 16 of the extension study (16 and 24 weeks, respectively,total dosing with apremilast) in reference to baseline of the core study

  • Proportion of subjects who achieve PASI-50, PASI-90 and PASI-100 [ Time Frame: From Baseline to either week 8, 16 or week 28 ] [ Designated as safety issue: No ]

    : • Proportion of subjects who achieve PASI-50, PASI-90, and PASI-100

    • At Weeks 8 and 16 of the extension study for placebo/apremilast subjects
    • At Week 28 of the extension study for all subjects

  • Time to achieve PASI-50 , PASI-75 , PASI-90 and PASI-100 during the treatment phase compared to baseline [ Time Frame: From core study baseline to end of treatment ] [ Designated as safety issue: No ]
    Time to achieve PASI-50 , PASI-75 , PASI-90 and PASI-100 from baseline to end of treatment compared to baseline in the core study in cases where these improvements were not achieved during the core study

  • Mean percent change from in PASI [ Time Frame: From baseline to week 8, 16 and week 28 ] [ Designated as safety issue: No ]

    Mean percent change in PASI

    • At Weeks 8 and 16 of the extension study for placebo/apremilast subjects
    • At Week 28 of the extension study for all subjects

  • Shift change (1 or more points on a 0 to 5 point scale) in static Physician Global Assessment (sPGA) [ Time Frame: From baseline to week 8, 16 and 28 ] [ Designated as safety issue: No ]

    Shift change (1 or more points on a 0 to 5 point scale) in sPGA

    • At Weeks 8 and 16 of the extension study for placebo/apremilast subjects
    • At Week 28 of the extension study for all subjects

  • Mean percent change in affected BSA during the treatment phase [ Time Frame: From baseline in the core study to end of treatment ] [ Designated as safety issue: No ]

    Mean percent change in affected BSA during the treatment phase compared to baseline in the core study

    • At Weeks 8 and 16 of the extension study for placebo/apremilast subjects
    • At Week 28 of the extension study for all subjects

  • Change from baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to week 8, 16 and 28 ] [ Designated as safety issue: No ]

    Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16 and 24

    • At Weeks 8 and 16 of the extension study for placebo/apremilast subjects
    • At Week 28 of the extension study for all subjects

  • Change from baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 [ Time Frame: Baseline to week 8, 16 and 28 ] [ Designated as safety issue: No ]

    Change from baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 at Week 16 and 24• Change in the Dermatology Life Quality Index (DLQI) and Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2

    • At Weeks 8 and 16 of the extension study for placebo/apremilast subjects
    • At Week 28 of the extension study for all subjects

  • Dose-response relationship using the percent reduction of PASI scores [ Time Frame: From baseline in the core study to week 28 in the extension study ] [ Designated as safety issue: No ]
    Dose-response relationship using the percent reduction of PASI scores at week 28 of the extension study for all subjects compared to baseline in the core study

  • Time to loss of response during the treatment phase of the extension study [ Time Frame: From baseline of extension study to end of treatment in extension study ] [ Designated as safety issue: No ]

    Time to loss of response during the treatment phase of the extension study

    - Time to 50% loss of the maximal improvement (achieved in either the core study or the extension study) during the treatment phase of the extension study, in subjects who achieved ≥ PASI-50 in either the core study or during the treatment phase of the extension study


  • Time to relapse post treatment in the extension study [ Time Frame: From end of treatment to the end of the 28 day observational follow-up phase ] [ Designated as safety issue: No ]

    Time to relapse pos treatment in the extension study (during the 28-day Observational Follow-up Phase)

    - Time to 50% loss of the PASI achieved at the end of treatment in the extension study, in subjects who achieved ≥ PASI-50



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 Drug: Apremilast 10mg
Apremilast 10 mg administered orally twice daily (BID) for 28 weeks during the active treatment phase followed by a 4 week observational follow up phase
Experimental: Apremilast 20mg Drug: Apremilast 20mg
Apremilast 20 mg administered orally twice daily (BID) for 28 weeks during the active treatment phase followed by a 4 week observational follow up phase
Experimental: Apremilast 30mg Drug: Apremilast 30mg
Apremilast 30 mg administered orally twice daily (BID) for 28 weeks during the active treatment phase followed by a 4 week observational follow up phase
Placebo Comparator: Placebo Drug: Identical Matching Placebo at the 10mg, 20mg and 30mg BID dose
Oral Placebo tablets administered twice daily (BID) for 28 weeks during the active phase followed by a 4 week observational follow up phase

Detailed Description:

CC-10004-PSOR-005E is the Phase 2B, multicenter, treatment-arm blind, randomized, safety and efficacy 32-week extension study in subjects with moderate to severe plaque-type psoriasis who previously completed the treatment phase in the core study. CC-10004-PSOR-005E is a long-term extension study that will collect safety and efficacy data on subjects dosed for an additional 28 weeks (for a total of up to 52 weeks) with 3 doses of apremilast. All sites successfully participating in the core study will be considered for participation in this extension study with required IRB/EC approval. Subjects will be eligible to enter the extension study upon completion of Week 24 of the core study provided they meet all eligibility requirements of the extension study. No minimum PASI score or BSA involvement will be required for eligibility into the extension study.

The extension study is divided into two phases:

  • Treatment Phase - 28 weeks of BID dosing of apremilast
  • Observational Follow-up Phase - 4 weeks posttreatment At Week 24 in the core study, subjects who have successfully completed the core study will be asked to participate in the treatment extension study. The design of the study will allow subjects to immediately enroll into the extension study so there is no interruption in their dosing schedule. Subjects will complete a Week 24 visit in the core study and take the AM dose of study medication from their core study supply of medication. If the subject qualifies for the extension study, he/she will receive study medication, commencing with the evening dose. The Week 24 visit in the core study will also coincide with the Baseline Visit (Week 0) in the extension study. The subjects will continue dosing in a treatment arm-blinded fashion at the same dose level they were receiving at the end of the core study: 10 mg BID, 20 mg BID, or 30 mg BID of 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 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
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: NCT00953875

  Show 32 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Irina Khanskaya 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: April 11, 2014
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
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014