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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00824980
• Other study ID #: IMTM_IP10.C8_II/1
• Status: Recruiting
• Phase: Phase 2
• First received: January 16, 2009
• Last updated: January 16, 2009
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: January 2009
• Source: Immune Technologies & Medicine GmbH
• Contact: Alexander Narvarini, M.D.
• Phone: 41 (0)44 255 11 11
• Email: alexander.navarini[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• IP10.C8
IP10.C8 Gel 1%

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Immune Technologies & Medicine GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index		4 weeks	No