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CT 327 in the Treatment of Psoriasis Vulgaris

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
CT 327
Sponsored by
Creabilis SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Mild to moderate psoriasis vulgaris

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Metrolina Medical Research
  • New Hanover Medical Research
  • Piedmont Medical Research, LLC
  • Premier Medical Group, P.C.
  • East Tennessee Medical Research
  • University Hospital
  • Inselspital
  • Kantonsspital
  • University Hospital
  • Synexus Midlands
  • Synexus Scotland
  • Synexus Wales

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo only

Active plus placebo

Arm Description

Subjects will apply placebo cream to both target lesions

Subjects will apply CT 327 to one target lesion and placebo to the other target lesion

Outcomes

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

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

Full Information

First Posted
October 15, 2009
Last Updated
February 9, 2011
Sponsor
Creabilis SA
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1. Study Identification

Unique Protocol Identification Number
NCT00995969
Brief Title
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

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Creabilis SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Mild to moderate psoriasis vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo only
Arm Type
Placebo Comparator
Arm Description
Subjects will apply placebo cream to both target lesions
Arm Title
Active plus placebo
Arm Type
Active Comparator
Arm Description
Subjects will apply CT 327 to one target lesion and placebo to the other target lesion
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1.0 g (w/w) placebo cream applied to both target lesions twice daily
Intervention Type
Drug
Intervention Name(s)
CT 327
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Metrolina Medical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
New Hanover Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Piedmont Medical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Premier Medical Group, P.C.
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
Facility Name
East Tennessee Medical Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital
City
St Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
University Hospital
City
Zürich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Synexus Midlands
City
Birmingham
State/Province
Midlands
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Synexus Scotland
City
Clydebank
State/Province
Strathclyde
ZIP/Postal Code
G81 2DR
Country
United Kingdom
Facility Name
Synexus Wales
City
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom

12. IPD Sharing Statement

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CT 327 in the Treatment of Psoriasis Vulgaris

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