- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00995969
CT 327 in the Treatment of Psoriasis Vulgaris
February 9, 2011 updated by: Creabilis SA
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel, Switzerland, CH-4031
- University Hospital
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Bern, Switzerland, 3010
- Inselspital
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St Gallen, Switzerland, CH-9007
- Kantonsspital
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Zürich, Switzerland, CH-8091
- University Hospital
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Cardiff, United Kingdom, CF14 5GJ
- Synexus Wales
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Midlands
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Birmingham, Midlands, United Kingdom, B15 2SQ
- Synexus Midlands
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Strathclyde
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Clydebank, Strathclyde, United Kingdom, G81 2DR
- Synexus Scotland
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North Carolina
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Charlotte, North Carolina, United States, 28209
- Metrolina Medical Research
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Wilmington, North Carolina, United States, 28401
- New Hanover Medical Research
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Winston-Salem, North Carolina, United States, 27103
- Piedmont Medical Research, LLC
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Tennessee
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Clarksville, Tennessee, United States, 37040
- Premier Medical Group, P.C.
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Johnson City, Tennessee, United States, 37604
- East Tennessee Medical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo only
Subjects will apply placebo cream to both target lesions
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1.0 g (w/w) placebo cream applied to both target lesions twice daily
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Active Comparator: Active plus placebo
Subjects will apply CT 327 to one target lesion and placebo to the other target lesion
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 8 weeks
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
Time Frame: 8 weeks
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
October 15, 2009
First Submitted That Met QC Criteria
October 15, 2009
First Posted (Estimate)
October 16, 2009
Study Record Updates
Last Update Posted (Estimate)
February 10, 2011
Last Update Submitted That Met QC Criteria
February 9, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT 327 PV 01-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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