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

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

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

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Drug: IP10.C8

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alexander Narvarini, M.D.; Phone Number: 41 (0)44 255 11 11; Email: alexander.navarini@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich
    • Contact: Alexander Navarini, Dr.med. Dr.sc.nat.; Phone Number: 41 (0)44 255 11 11; Email: alexander.navarini@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Age 18 years of age at pre-study and
2. Diagnosis of plaque type psoriasis at least 3 month prior to enrolment
3. Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15cm2 for which topical treatment is indicated
4. Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2

Exclusion Criteria:

1. Other type of psoriasis (e.g. erythrodermic, guttate or pustular) at enrolment
2. Drug induced psoriasis at enrolment (e.g. lithium)
3. Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study
4. Systemic therapy affecting PASI or phototherapy for a period of 4 weeks prior to enrolment
5. Topical therapy affecting PASI for a period of 2 weeks prior to enrolment
6. Treatment with biologic agents affecting PASI for a period of 3 months prior to enrolment
7. 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
8. Having a history of or an ongoing uncontrolled serious or recurring bacterial, viral, fungal, or atypical mycobacterial infection
9. 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
10. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Gel	Drug: IP10.C8; IP10.C8 Gel 1%
EXPERIMENTAL: IP10.C8 Gel	Drug: IP10.C8; IP10.C8 Gel 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Psoriasis Area and Severity Index	4 weeks

Collaborators and Investigators

• Sponsor: Immune Technologies & Medicine GmbH
• Investigators: Principal Investigator: Lars E French, Prof., University Hospital Zurich Department of Dermatology / Gloriastrasse 31

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ANTICIPATED): September 1, 2009
• Study Completion (ANTICIPATED): September 1, 2009

Study Registration Dates

• First Submitted: January 16, 2009
• First Submitted That Met QC Criteria: January 16, 2009
• First Posted (ESTIMATE): January 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 19, 2009
• Last Update Submitted That Met QC Criteria: January 16, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: IMTM_IP10.C8_II/1