Contact information
Type
Scientific
Primary contact
Dr M A de Rie
ORCID ID
Contact details
Academic Medical Centre
Polikliniek Huidziekten
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 2585
m.a.derie@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P03657
Study information
Scientific title
Acronym
Study hypothesis
Several reports have indicated that the chemokine receptor CCR5 and its ligands, especially CCL5 (formerly known as RANTES), may play a role in the pathogenesis of psoriasis. CCR5 targeted treatment could therefore be a therapeutic option for psoriasis patients.
Ethics approval
Approval received from the local ethics board (Medical Ethics Committe AMC) on the 31st March 2004 (ref: 04/44).
Study design
Randomised, placebo-controlled, parallel group, double blinded multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Psoriasis
Intervention
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 matched placebo, in a 2:1 ratio, for 28 days.
Intervention type
Drug
Phase
Not Specified
Drug names
SCH 351125
Primary outcome measure
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 measures
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)
Overall trial start date
01/04/2004
Overall trial end date
01/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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 lesions 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
32
Participant 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
Recruitment start date
01/04/2004
Recruitment end date
01/12/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Schering-Plough B.V. (The Netherlands)
Sponsor details
Maarssenbroeksedijk 4-II
Utrecht
3542 DN
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Schering-Plough B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list