CT 327 in the Treatment of Psoriasis Vulgaris

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995969
• Other study ID #: CT 327 PV 01-09
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2009
• Last updated: February 9, 2011
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: Creabilis SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• placebo
1.0 g (w/w) placebo cream applied to both target lesions twice daily
• CT 327
1.0 g CT 327 cream will be applied to one target lesion twice daily and 1.0 g placebo cream will be applied to the remaining target lesion twice daily

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel
Switzerland	Inselspital	Bern
Switzerland	Kantonsspital	St Gallen
Switzerland	University Hospital	Zürich
United Kingdom	Synexus Midlands	Birmingham	Midlands
United Kingdom	Synexus Wales	Cardiff
United Kingdom	Synexus Scotland	Clydebank	Strathclyde
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	Premier Medical Group, P.C.	Clarksville	Tennessee
United States	East Tennessee Medical Research	Johnson City	Tennessee
United States	New Hanover Medical Research	Wilmington	North Carolina
United States	Piedmont Medical Research, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Creabilis SA

Countries where clinical trial is conducted

United States,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		8 weeks	No
Secondary	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		8 weeks	No