PsoriasisPhase 2NCT00824980
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis
A Phase 2 study testing IP10.C8 in people with Psoriasis, run by Immune Technologies & Medicine GmbH at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Psoriasis
- What is being tested?
- IP10.C8
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Alexander Navarini, Dr.med. Dr.sc.nat., 41 (0)44 255 11 11, alexander.navarini@usz.ch
About this study
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
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
- Conditions
- Psoriasis
- Being tested
- IP10.C8
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP10.C8Drug
IP10.C8 Gel 1%
| Study group | Role | What they receive |
|---|---|---|
| IP10.C8 Gel | Experimental | Not described Receives: Drug: IP10.C8 |
| Placebo Gel | Placebo comparator | Not described Receives: Drug: IP10.C8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune Technologies & Medicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lars E French, Prof., Principal investigator, University Hospital Zurich Department of Dermatology / Gloriastrasse 31
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824980
- Sponsor's protocol ID
- IMTM_IP10.C8_II/1
- Status last verified
- Jan 2009
- First submitted
- 16 Jan 2009
- Last updated
- 19 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00824980
- Acronym / sponsor ID
- IMTM_IP10.C8_II/1
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Immune Technologies & Medicine GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IP10.C8 Gel | Experimental | Drug: IP10.C8 |
| Placebo Gel | Placebo comparator | Drug: IP10.C8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IP10.C8IP10.C8 Gel 1% | Drug | IP10.C8 Gel, Placebo Gel |
Primary outcome
Psoriasis Area and Severity Index
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars E French, Prof. principal investigator
University Hospital Zurich Department of Dermatology / Gloriastrasse 31
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IP10.C8 in people with Psoriasis, run by Immune Technologies & Medicine GmbH at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Narvarini, M.D. (41 (0)44 255 11 11, alexander.navarini@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2009.