Condition category
Skin and Connective Tissue Diseases
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
13/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 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

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

http://www.schering-plough.com/schering_plough/index.jsp

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes