Moderate to Severe Plaque-type Psoriasis MedDRA version: 15.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent; Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment); Must be considered, in the opinion of the investigator, suitable candidates for adalimumab (HUMIRA) therapy; If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active; If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 265 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease; Has unstable cardiovascular disease; Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to administration of any study agent); Has a history of chronic or recurrent infectious disease; Has been previously treated with adalimumab; Is infected with human immunodeficiency virus (HIV, positive serology for HIV antibody).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.;Secondary Objective: - To evaluate the durability of clinical response to different dose levels and dose regimens of CNTO 1959 in plaque psoriasis in order to guide the development of a maintenance regimen for the treatment of psoriasis. - To assess the relative difference of short-term and long-term responses between the adalimumab and CNTO 1959 treatment groups. -To assess the pharmacokinetics and immunogenicity of CNTO 1959 following SC administration in subjects with moderate to severe plaque psoriasis. - To assess the impact of treatment with CNTO 1959 on the health-related quality of life in subjects with moderate to severe plaque psoriasis.;Primary end point(s): Physician’s Global Assessment (PGA) score of Cleared or minimal (Overall assessment of induration, scaling, and erythema);Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Psoriasis Area and Severity Index (PASI) 75% or greater improvement from baseline (Overall assessment of induration, scaling, and erythema and body surface area involved by the disease) 2. The difference in the PGA score of cleared (0) or minimal (1) response rate between CNTO 1959 treatment groups and adalimumab treatment group 3. The change in Dermatology Life Quality Index (DLQI) (Assessment of the impact of the disease on a subject’s quality of life);Timepoint(s) of evaluation of this end point: 1. Week 16 2. Week 16 and 40 3. Week 16 | — |
Countries
Belgium, Canada, Germany, Poland, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed