Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Immune Technologies & Medicine GmbH.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Immune Technologies & Medicine GmbH

ClinicalTrials.gov Identifier:

NCT00824980

First received: January 16, 2009

Last updated: NA

Last verified: January 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

January 16, 2009

Last Updated Date

January 16, 2009

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Psoriasis Area and Severity Index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis

Official Title ^ICMJE

Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis - Phase II Single Center Study

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: IP10.C8

IP10.C8 Gel 1%

Study Arm (s)

Experimental: IP10.C8 Gel
Intervention: Drug: IP10.C8
Placebo Comparator: Placebo Gel
Intervention: Drug: IP10.C8

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Alexander Narvarini, M.D.

41 (0)44 255 11 11

alexander.navarini@usz.ch

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00824980

Other Study ID Numbers ^ICMJE

IMTM_IP10.C8_II/1

Has Data Monitoring Committee

Responsible Party

Curdin Conrad, M.D., Dermatologische Klinik, Gloriastrasse 31, USZ, CH-8091 Zürich

Study Sponsor ^ICMJE

Immune Technologies & Medicine GmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lars E French, Prof.

University Hospital Zurich Department of Dermatology / Gloriastrasse 31

Information Provided By

Immune Technologies & Medicine GmbH

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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