The effects of SCH351125 on posriatic plaque immunohistochemistry, and chemokine expression in patients with moderate to severe psoriasis (protocol No.P03657) SCH351125.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR880
• Date of registration: 24/01/2007
• Primary sponsor: Schering-Plough B.V.
• Public title: The effects of SCH351125 on posriatic plaque immunohistochemistry, and chemokine expression in patients with moderate to severe psoriasis (protocol No.P03657) SCH351125.
• Scientific title: (protocol No.P03657) SCH351125: the effects of SCH351125 on posriatic plaque immunohistochemistry, and chemokine expression in patients with moderate to severe psoriasis. - N/A
• Date of first enrolment: 1/4/2004
• Target sample size: 32
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=880
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: M.A. Rie, de

• Name: M.A. Rie, de

Key inclusion & exclusion 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 (PASI > 8) 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 cm2 in size;

4. The selected target lesion?s total numerical ratings for erythema, induration, and scaling must be at least 6 out of the possible 9 using the following definitions for each sign: 0=none, 1=mild, 2=moderate, 3= severe. The severity score for scaling must be at least 2;

5. Subjects? clinical laboratory tests (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 nonchildbearing potential (ie, sterilized via hysterectomy or bilateral tubal ligation or at least 1 year postmenopausal) or if of child bearing potential, must be practicing effective contraceptive methods from at least 2 weeks prior to Day 1 and until 30 days following cessation of dosing;

9. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at Screening.
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 with in 6 weeks of treatment or topical antipsoriasis 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 preexisting 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 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Subjects with moderate/severe chronic plaque sporiasis were enrolled in a randomized double-blind, placebo-controlled, parallel-group study exposed to either SCH 351125 50 mg BID or matched placebo, in a 2:1 ratio. for 28 days.

Primary Outcome(s)

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 Outcome(s)

1. Expression of chemokine 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).

Secondary ID(s)

ISRCTN14986467

N/A

Source(s) of Monetary Support

Schering-Plough