Clinical trial NCT00995969: CT 327 in the Treatment of Psoriasis Vulgaris
Official title: A Randomized, Double-Blind, Placebo Controlled Phase II, Multi-Centre, Study of the Efficacy and Safety of CT 327, a Topical Cream Formulation of Pegylated K252a, When Administered Twice Daily for Eight Weeks to Patients With Mild to Moderate Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Mild to moderate psoriasis vulgaris
Lead sponsor: Creabilis SA
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed throughout the treatment period.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 and \< 71 years of age
* Able to give informed consent
* Diagnosis of mild (affecting \< 3% BSA) to moderate (affecting \< 10% BSA) Psoriasis Vulgaris, including, at baseline visit, two symmetrical lesions of at least 10 cm2 each

Exclusion Criteria:

* If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
* If female, are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter
* Allergy to test drug or excipients
* Usage of topical corticosteroids or other topical treatments for PV within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
* Received treatment with systemic or locally acting medications which might counter or influence the study aim
* Presence of major medical illness requiring systemic therapy including cancers
* Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
* Any clinical relevant ECG abnormality
* Have any clinically significant abnormal clinical laboratory test results at screening
* Received any investigational drug or taking part in any clinical study within three months prior to this study
* History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
* Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
* Have immune-compromised status (such as known human immunodeficiency virus infection)
* Have a history of malignancy, excluding basal cell carcinoma of the skin
* Have an active intercurrent infection
* Suffer from erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis
* Have symptoms of a clinically significant illness that may influence the outcome of the study
* Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk

Primary outcomes:
measure: Improvements from baseline on m-Psoriasis Area Severity Index Scale (m-PASI - modified to exclude area assessment): Proportion of subjects with a reduction in score of > 50% at Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: To assess the efficacy of an 8-week treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-PASI-score of > 75% a Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research, LLC
state: North Carolina
city: Clarksville
country: United States
facility: Premier Medical Group, P.C.
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee Medical Research
state: Tennessee
city: Basel
country: Switzerland
facility: University Hospital
city: Bern
country: Switzerland
facility: Inselspital
city: St Gallen
country: Switzerland
facility: Kantonsspital
city: Zürich
country: Switzerland
facility: University Hospital
city: Birmingham
country: United Kingdom
facility: Synexus Midlands
state: Midlands
city: Clydebank
country: United Kingdom
facility: Synexus Scotland
state: Strathclyde
city: Cardiff
country: United Kingdom
facility: Synexus Wales
Study officials:
References: