chronic plaque psoriasis
Conditions
Interventions
This is a 52-week, double-blind, treatment period where subjects are randomized
in a 1:1 ratio to receive either ABT-874 or MTX.
Sponsors
Abbott
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Males and females 18 years of age and over with diagnosis of stable moderate to severe plaque psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by the Principal Investigator. 2. stable for at least 2 months before screening and at baseline 3. moderate to severe posriasis defined by >=10% Body surface Area (BSA) at baseline 4. PGA of at least moderate disease (defined as PGA >=3) at the baseline 5. PASI score of >= 12 at baseline 6. women childbearing potential must undergo monthly pregnancy testing during the study and agree to use two methods of contraception throughout the study, or postmenopausal for at least one year or sterile or hysterectomized;Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray (CXR), and 12-lead electrocardiogram (ECG) performed at Screening.;Able and willing to give written informed consent and to comply with the requirements of this study protocol.
Exclusion criteria
Exclusion criteria: 1. previous exposure to systemic anti IL 12 therapy 2. previous exposure to MTX 3. diagnose of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication induced or medication exacerbated psoriasis or new onset guttate psoriasis 4. history of an allergic reaction or sensitivity to constituents of study drug 5. Unable to discontinue not allowed topical or systemic therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, UVB phototherapy or retinoids at least 2 weeks and PUVA phototherapy at least 4 weeks prior to the Baseline (Week 0) visit and during the study 6. cannot discontinue systemic therapies for the treatment of psoriasis 7. patient is taking or requires oral or injecttable corticosteroids 8. poorly controlled medical condition 9. history of clinically significant hematologic, renal or liver disease 10. patient has infection or risk factors for severe infections 11. history of malignancies other than successfully treated cell carcinoma 12. history of major immunologic reaction 13. exarcebation of asthma requiring hospitalization in the ten years prior screening 14. pregnant female or breast feeding or considering become pregnant 15. clinical significant abnormal lab. values 16. recent history of substance abuse or psychiatric illness 17. allergic hypersensitivity to MTX 18. rare hereditary problems of galactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Key study endpoints will be based on the Psoriasis Area and Severity Index (PASI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Other efficacy and quality of life parameters to be evaluated during the study include the 6-point Physicians Global Assessment (PGA), Dermatology Life Quality Index (DLQI), EQ-5D Health Questionnaire, Patient's Global Assessment of Psoriasis-Severity, Psoriasis Related Pruritus Assessment, Visual Analog Scale (VAS) for Plaque Psoriasis and Psoriatic Arthritis Pain, NAPSI, and NPGA. | — |
Countries
Netherlands
Outcome results
None listed