Overview

This trial is active, not recruiting.

Conditions psoriasis, psoriatic arthritis
Treatments apremilast tablet/pill 30 mg, etanercept 50 mg, placebo tablet, placebo injection (saline)
Phase phase 3
Sponsor Celgene Corporation
Start date October 2012
End date July 2014
Trial size 250 participants
Trial identifier NCT01690299, 2012-000859-14, CC-10004-PSOR-010

Summary

This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.

Apremilast (CC-10004) is a new oral agent that is under clinical development for the treatment of inflammatory autoimmune disorders, such as psoriatic arthritis, psoriasis, rheumatoid arthritis, and Behçet disease.

Etanercept is approved for the treatment of psoriasis; it is the most widely prescribed anti-tumor necrosis factor (TNF) for psoriasis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
apremilast tablet/pill 30 mg CC-10004
Apremilast tablet/pill 30 mg tablet orally twice a day
placebo injection (saline) Placebo
once weekly evaluator/subject-blinded subcutaneous saline (placebo) injections (1 mL x 2 injections SC)
(Experimental)
etanercept 50 mg ETN
Etanercept 50 mg evaluator/subject-blinded subcutaneous once weekly injection
placebo tablet Placebo
Placebo tablets twice a day
(Placebo Comparator)
placebo tablet Placebo
Placebo tablets twice a day
placebo injection (saline) Placebo
once weekly evaluator/subject-blinded subcutaneous saline (placebo) injections (1 mL x 2 injections SC)

Primary Outcomes

Measure
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline
time frame: Baseline to Week 16

Secondary Outcomes

Measure
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16 From Baseline
time frame: Baseline and Week 16
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline and Week 16
Percent Change From Baseline in the Affected Body Surface Area (BSA%) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline to Week 16
Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: From Baseline to Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline to Week 16
Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline and Week 16
Percentage of Participants With a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
time frame: Baseline to Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Phase
time frame: First dose of study drug to the end of the placebo controlled phase
Psoriasis Flare/Rebound
time frame: First dose of study drug to the end of the placebo controlled phase

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Males or females, ≥ 18 years of age - Diagnosis of chronic, moderate to severe plaque psoriasis for at least 12 months prior to Screening, and a candidate for phototherapy and/or systemic (including etanercept) therapy - Had an inadequate response, intolerance, or contraindication to at least 1 conventional systemic agent for the treatment of psoriasis. - No prior exposure to biologics for treatment of psoriatic arthritis or psoriasis Exclusion Criteria: - Other than psoriasis, history of any clinically significant and uncontrolled systemic diseases; any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study. - Pregnant or breast feeding. - Have failed more than 3 systemic agents for treatment of psoriasis. - History of allergy to any component of the investigational product (IP), including human immunoglobulin (Ig) proteins or allergy to etanercept. - Hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening. - Latent, active tuberculosis (TB) or inadequately treated TB; nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, Clostridium difficile). - Have a history of, or ongoing, chronic or recurrent infectious disease - Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before first administration of IP, or through Week 20 during the study. - Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening. - History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease). - Active substance abuse or a history of substance abuse within 6 months prior to Screening. - Malignancy or history of malignancy, except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years. - Psoriasis flare or rebound within 4 weeks prior to Screening. - Topical therapy within 2 weeks of randomization or systemic therapy for psoriasis within 4 weeks prior to randomization - Use of phototherapy within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources. - Any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer). - Prior treatment with apremilast or etanercept.

Additional Information

Official title A Phase 3b, Multicenter, Randomized, Placebo-Controlled, Double Blind, Double-Dummy, Study of the Efficacy and Safety of Apremilast (CC-10004), Etanercept, and Placebo, in Subjects With Moderate to Severe Plaque Psoriasis
Description This is a phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy, study of the efficacy and safety of apremilast, etanercept, and placebo, in subjects with moderate to severe plaque psoriasis. Approximately 240 subjects will be randomized 1:1:1 to the three treatment groups. All subjects will receive both tablets and injections through Week 16. The study will consist of four phases: - Screening Phase - up to 35 days - Double-blind Placebo-controlled Phase - Weeks 0-16 - Apremilast Extension Phase - Weeks 16-104 - Post-treatment Observational Follow-up Phase During the double-blind, placebo-controlled phase, subjects will receive treatment with one of the following: - apremilast (APR) 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections (1 mL x 2 injections SC), or - etanercept (ETN) 50 mg evaluator/subject-blinded subcutaneous (SC) once weekly (QW) injections (2 x 25 mg) plus placebo tablets orally twice a day (BID), or - placebo tablets and evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections. All subjects will be asked to participate in a 4-week Post-treatment Observational Follow-up Phase either upon completion of the study or upon discontinuation of investigational product for those subjects who terminate the study early.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Celgene Corporation.