SCH 351125: the effects of SCH 351125 on psoriatic plaque immuno-histochemistry, and chemokine expression in patients with moderate to severe psoriasis

ISRCTN	ISRCTN14986467
DOI	https://doi.org/10.1186/ISRCTN14986467
Secondary identifying numbers	P03657

Submission date: 08/02/2007
Registration date: 08/02/2007
Last edited: 26/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M A de Rie
Scientific

Academic Medical Centre
Polikliniek Huidziekten
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 2585
Email	m.a.derie@amc.uva.nl

Study information

Study design	Randomised, placebo-controlled, parallel group, double blinded multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	SCH 351125: the effects of SCH 351125 on psoriatic plaque immuno-histochemistry, and chemokine expression in patients with moderate to severe psoriasis
Study objectives	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(s)	Approval received from the local ethics board (Medical Ethics Committe AMC) on the 31st March 2004 (ref: 04/44).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/04/2004
Completion date	01/12/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	32
Total final enrolment	32
Key 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
Key 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
Date of first enrolment	01/04/2004
Date of final enrolment	01/12/2004

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Amsterdam
1105 AZ
Netherlands

Sponsor information

Schering-Plough B.V. (The Netherlands)
Industry

Maarssenbroeksedijk 4-II
Utrecht
3542 DN
Netherlands

Website	http://www.schering-plough.com/schering_plough/index.jsp
"ROR"	https://ror.org/05y28vr04

Funders

Funder type

Industry

Schering-Plough
Private sector organisation / For-profit companies (industry)

Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/09/2007	26/03/2021	Yes	No

Editorial Notes

26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.