Overview

This trial is active, not recruiting.

Conditions psoriasis;, psoriatic arthritis;, psoriasis arthropatica
Treatments apremilast, placebo
Phase phase 2
Sponsor Celgene Corporation
Start date May 2013
End date November 2014
Trial size 254 participants
Trial identifier NCT01988103, CC-10004-PSOR-011

Summary

This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.

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

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
20 mg tablet twice a day for 68 weeks
(Experimental)
apremilast
30 mg tablet twice a day for 68 weeks
(Placebo Comparator)
placebo
Placebo tablet twice a day for 16 weeks followed by apremilast 20 mg tablet twice a day for 52 weeks
placebo
Placebo tablet twice a day for 16 weeks followed by apremilast 30 mg tablet twice a day for 52 weeks

Primary Outcomes

Measure
Psoriasis Area and Severity Index-75 (PASI-75).
time frame: Week 16

Secondary Outcomes

Measure
Static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1)
time frame: Week 16
Percent Change from baseline in the psoriasis affected Body Surface Area (BSA %)
time frame: Week 16
Percent Change in the Psoriasis Area and Severity Index (PASI ) score
time frame: From Baseline at Week 16
Proportion of subjects who achieve PASI-50
time frame: Week 16
Change from baseline in Pruritus (itch) Visual Analogue Scale (VAS)
time frame: Week 16
Change from baseline in Dermatology Life Quality Index (DLQI) total score
time frame: Week 16
Change from baseline in Mental Component Summary (MCS) score of SF-36
time frame: Week 16
Adverse Events
time frame: Weeks 16 and 68
American College of Rheumatology criteria for a 20% improvement (ACR 20)
time frame: Week 16
Psoriatic Arthritis Pain Visual Analogue Scale (VAS)
time frame: Week 16
Health Assessment Questionnaire Disability Index (HAQ-DI)
time frame: Week 16
Pharmacokinetics - Cmax
time frame: Week 20
Pharmacokinetics - Tmax
time frame: Week 20
Pharmacokinetics - AUC0-8 and AUC0-τ
time frame: Week 20
Pharmacokinetics - t1/2
time frame: Week 20
Pharmacokinetics - CLss/F
time frame: Week 20
Pharmacokinetics - Vss/F
time frame: Week 20
Population Pharmacokinetics (sparse sampling) - CL/F
time frame: Weeks 8-24
Population Pharmacokinetics (sparse sampling) - Vc/F
time frame: Week 8-24
Population Pharmacokinetics (sparse sampling) - KA
time frame: Week 8-24

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Male or female Japanese subjects greater than or equal to 20 years of age. - Diagnosis of chronic, stable plaque psoriasis for at least 6 months prior to screening as defined by: PASI score ≥ 12 and BSA ≥ 10%. - Psoriasis which is considered inappropriate for topical therapy (based on severity of disease and extent of affected area) or has not been adequately controlled or treated by topical therapy in spite of at least 4 weeks of prior therapy with at least one topical medication for psoriasis or per label. - In otherwise good health based on medical history, physical examination, 12-lead ECG, serum chemistry, hematology, immunology, and urinalysis. 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 or confound the ability to interpret the data in the study. Prior medical history of suicide attempt or major psychiatric illness requiring hospitalization within the last 3 years - Pregnant or breastfeeding. - History of or ongoing chronic or recurrent infectious disease. - Active tuberculosis (TB) or a history of incompletely treated TB. - Clinically significant abnormality on 12-lead ECG or on chest radiograph at screening. - History of human immunodeficiency virus (HIV) infection or have congenital or acquired immunodeficiencies (eg, Common Variable Immunodeficiency). - Hepatitis B surface antigen or hepatitis B core antibody positive at screening; positive for antibodies to hepatitis C at screening. - Malignancy or history of malignancy, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas or treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within previous 5 years. - Psoriasis flare within 4 weeks of screening. - Topical therapy within 2 weeks prior to randomization or systemic therapy for psoriasis or psoriatic arthritis within 4 weeks prior to randomization. - Use of etretinate within 2 years prior to randomization for females of child bearing potential (FCBP) or within 6 months for males, and within 4 weeks prior to randomization for non-FCBP. - Use of phototherapy (ie, UVB, PUVA) within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet light sources. - Use of adalimumab, etanercept, certolizumab pegol, abatacept, tocilizumab, golimumab or infliximab within 12 weeks prior to randomization; use of ustekinumab, alefacept or briakinumab within 24 weeks prior to randomization. - Any investigational drug within 4 weeks prior to randomization.

Additional Information

Official title A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Subjects With Moderate-To-Severe Plaque-Type Psoriasis
Description This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of apremilast 20 mg twice a day (BID), apremilast 30 mg BID, and placebo in Japanese subjects with moderate to severe plaque psoriasis.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Celgene Corporation.