Psoriasis Skin and Connective Tissue Diseases Papulosquamous disorders
Conditions
Interventions
Subjects with moderate/severe chronic plaque psoriasis were enrolled in a randomised double-blind, placebo-controlled, parallel-group study exposed to either SCH 351125 50 mg twice daily (BID) or matc
Sponsors
Schering-Plough B.V. (The Netherlands)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 18 to 75 years of age, of either sex, and of any race 2. Patients must not be currently receiving treatment and have a diagnosis of moderate to severe psoriasis vulgaris (Psoriasis Area and Severity Index [PASI] more than eight) which must be established and must have been present for at least one year 3. The target lesion selected must be located on the trunk, arms or legs and be at least 10 cm^2 in size 4. The selected target lesion?s total numerical ratings for erythema, induration, and scaling must be at least six out of the possible nine using the following definitions for each sign: zero = none, one = mild, two = moderate, three = severe. The severity score for scaling must be at least two 5. Subjects? clinical laboratory tests (Complete Blood Count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor 6. Subjects must be free of any clinically significant disease (other than psoriasis) that would interfere with the study evaluations and/or study safety 7. Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules 8. Females must not be breastfeeding, and either be of non-childbearing potential (I.e., sterilised via hysterectomy or bilateral tubal ligation or at least one year postmenopausal) or if of child bearing potential, must be practicing effective contraceptive methods from at least two weeks prior to day one and until 30 days following cessation of dosing 9. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-human Chorionic Gonadotropin [hCG]) at screening
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant, intend to become pregnant, or are nursing 2. Subjects who have taken methotrexate, cyclosporin or systemic retinoids within six weeks of treatment or topical anti-psoriasis therapy within two weeks of treatment. All other prescription medication must be discontinued for at least 28 days prior to treatment. No other drugs (except acetaminophen), including vitamins, herbal supplements, homeopathic or over the counter medications are allowed with 14 days of treatment administration 3. Excluded treatments during the study. Subjects who must take any drug during the study period 4. Subjects with any pre-existing cardiovascular disease 5. Individuals who have received any vaccinations within 30 days prior to screening or a scheduled to receive a vaccination during the study 6. Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or for Human Immunodeficiency Virus (HIV) antibodies 7. Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study 8. Subjects who have used any investigational drugs within 28 days of screening 9. Subjects who are not willing to follow the study restrictions or procedures 10. Individuals with any clinically significant history of food or drug allergy or allergy to any component of SCH 351125 11. Subjects who are participating in any other clinical study 12. Subjects who are part of the staff personnel directly involved with this study 13. Subjects who are a family member of the investigational study staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the effects of SCH 351125, a CCR5 receptor antagonist, on psoriatic plaque cellularity 2. To determine safety and tolerability of SCH 351125 in psoriatic patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Expression of chemokine messenger RiboNucleic Acid (mRNA) within the psoriatic plaque and peripheral blood 2. Peripheral blood chemokines and CCR5 expressing cells 3. Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA) | — |
Countries
Netherlands
Outcome results
None listed