CT 327 in the Treatment of Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by:
Creabilis SA
ClinicalTrials.gov Identifier:
NCT00995969
First received: October 15, 2009
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: placebo
Drug: CT 327
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Creabilis SA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo only
Subjects will apply placebo cream to both target lesions
Drug: placebo
1.0 g (w/w) placebo cream applied to both target lesions twice daily
Active Comparator: Active plus placebo
Subjects will apply CT 327 to one target lesion and placebo to the other target lesion
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995969

Locations
United States, North Carolina
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
New Hanover Medical Research
Wilmington, North Carolina, United States, 28401
Piedmont Medical Research, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Tennessee
Premier Medical Group, P.C.
Clarksville, Tennessee, United States, 37040
East Tennessee Medical Research
Johnson City, Tennessee, United States, 37604
Switzerland
University Hospital
Basel, Switzerland, CH-4031
Inselspital
Bern, Switzerland, 3010
Kantonsspital
St Gallen, Switzerland, CH-9007
University Hospital
Zürich, Switzerland, CH-8091
United Kingdom
Synexus Midlands
Birmingham, Midlands, United Kingdom, B15 2SQ
Synexus Scotland
Clydebank, Strathclyde, United Kingdom, G81 2DR
Synexus Wales
Cardiff, United Kingdom, CF14 5GJ
Sponsors and Collaborators
Creabilis SA
  More Information

No publications provided

Responsible Party: Professor Nikhil Yawalkar, Inselspital Bern
ClinicalTrials.gov Identifier: NCT00995969     History of Changes
Other Study ID Numbers: CT 327 PV 01-09
Study First Received: October 15, 2009
Last Updated: February 9, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by Creabilis SA:
Mild to moderate psoriasis vulgaris

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014