Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2012 |
End Date: | April 2016 |
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
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.
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.
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.
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.
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.
We found this trial at
33
sites
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2095 Langhorne Road
Lynchburg, Virginia 24501
Lynchburg, Virginia 24501
434-847-8400
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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801 N Rutledge St
Springfield, Illinois 62702
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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