Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
IP10.C8
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Age 18 years of age at pre-study and
- Diagnosis of plaque type psoriasis at least 3 month prior to enrolment
- Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15cm2 for which topical treatment is indicated
- Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2
Exclusion Criteria:
- Other type of psoriasis (e.g. erythrodermic, guttate or pustular) at enrolment
- Drug induced psoriasis at enrolment (e.g. lithium)
- Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study
- Systemic therapy affecting PASI or phototherapy for a period of 4 weeks prior to enrolment
- Topical therapy affecting PASI for a period of 2 weeks prior to enrolment
- Treatment with biologic agents affecting PASI for a period of 3 months prior to enrolment
- Systemic treatment with immunosuppressive agents (e.g. methotrexate, cyclosporin) or treatment with lithium, anti-malaria medication, or intramuscular gold application for a period of 4 weeks prior to enrolment
- Having a history of or an ongoing uncontrolled serious or recurring bacterial, viral, fungal, or atypical mycobacterial infection
- Having a severe medical condition that, in the judgment of the investigator, would jeopardize in any way the subject's safety following exposure to study drug
- Having the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled
Sites / Locations
- University Hospital ZurichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IP10.C8 Gel
Placebo Gel
Arm Description
Outcomes
Primary Outcome Measures
Psoriasis Area and Severity Index
Secondary Outcome Measures
Full Information
NCT ID
NCT00824980
First Posted
January 16, 2009
Last Updated
January 16, 2009
Sponsor
Immune Technologies & Medicine GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00824980
Brief Title
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis
Official Title
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis - Phase II Single Center Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Immune Technologies & Medicine GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The major objective of this study is to evaluate the therapeutic effect of a topical treatment simultaneously inhibiting Dipeptidyl Peptidase IV and Aminopeptidase N (IMTM #IP10.C8) in patients with mild to moderate psoriasis of the skin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IP10.C8 Gel
Arm Type
Experimental
Arm Title
Placebo Gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IP10.C8
Intervention Description
IP10.C8 Gel 1%
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years of age at pre-study and
Diagnosis of plaque type psoriasis at least 3 month prior to enrolment
Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15cm2 for which topical treatment is indicated
Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2
Exclusion Criteria:
Other type of psoriasis (e.g. erythrodermic, guttate or pustular) at enrolment
Drug induced psoriasis at enrolment (e.g. lithium)
Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study
Systemic therapy affecting PASI or phototherapy for a period of 4 weeks prior to enrolment
Topical therapy affecting PASI for a period of 2 weeks prior to enrolment
Treatment with biologic agents affecting PASI for a period of 3 months prior to enrolment
Systemic treatment with immunosuppressive agents (e.g. methotrexate, cyclosporin) or treatment with lithium, anti-malaria medication, or intramuscular gold application for a period of 4 weeks prior to enrolment
Having a history of or an ongoing uncontrolled serious or recurring bacterial, viral, fungal, or atypical mycobacterial infection
Having a severe medical condition that, in the judgment of the investigator, would jeopardize in any way the subject's safety following exposure to study drug
Having the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Narvarini, M.D.
Phone
41 (0)44 255 11 11
Email
alexander.navarini@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars E French, Prof.
Organizational Affiliation
University Hospital Zurich Department of Dermatology / Gloriastrasse 31
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Navarini, Dr.med. Dr.sc.nat.
Phone
41 (0)44 255 11 11
Email
alexander.navarini@usz.ch
12. IPD Sharing Statement
Learn more about this trial
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis
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