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In this study, the safety, tolerability and efficacy of DLX105 administered topically onto the psoriatic lesion of mild-to-moderate psoriasis patients will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLX105 Hydrogel | Active Comparator |
| |
| Placebo Hydrogel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLX105 Hydrogel | Drug | topical administration on psoriatic plaque |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of local tolerability by the investigator | using a validated score for each treatment area | up to 6 weeks |
| assessment of local tolerability sensations by the patient | using a visual analogue scale for each treatment area | up to 6 weeks |
| collection of Adverse Events | up to 6 weeks | |
| Determination of efficacy of DLX105 as compared to baseline | assessment of Local PASI score per plaque measured at week 4 compared to baseline | Baseline to Week 4 |
| Determination of efficacy of DLX105 as compared to Placebo at week 4 | Local PASI difference at week 4 between DLX105 and placebo | baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Immunogenicity | Anti-drug-antibodies will be determined to assess the immunogenic potential of DLX105. | up to 6 weeks |
| Detection of Pharmacokinetics | Pharmacokinetics through levels will be measured in serum at 4 time points over 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
Forms of psoriasis other than chronic plaque-type only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, plantar or nail disease) at screening.
Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) prior to randomization
Ongoing use of prohibited psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
Intake of any investigational drug or participation in a Clinical Trial within 4 weeks or 5 half-lives, (whichever is longer) prior to baseline.
History or evidence of active tuberculosis. All patients will be tested for tuberculosis status using a blood test (QuantiFERON TB-Gold) unless this test has been performed within 4 months prior to randomization and was negative. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
Active systemic infections (other than common cold) during the two weeks before randomization
Positive test for hepatitis B or C at screening
Positive test for HIV at screening
History or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratosis, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
History of severe hypersensitivity to any human or humanized biological agents
Any severe, progressive or uncontrolled medical condition at baseline that in the judgment of the investigator prevents the patient from participating in the study.
Any clinically significant abnormal laboratory tests at screening
Active liver disease with alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 3 x upper limit of normal at screening
History of moderate or severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
Inability or unwillingness to undergo repeated venipunctures (e.g., due to poor tolerability or lack of access to veins)
History or evidence of drug or alcohol abuse within the 6 months prior first study drug administration
Patients who had live vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial
History of hypersensitivity to any of the excipients of the study drugs or to excipients of similar chemical classes
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (HCG) laboratory test (> 5 mIU/mL)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are women whose partners have been sterilized by vasectomy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital AKH | Vienna | Austria | ||||
| University Hospital |
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| Placebo |
| Drug |
topical administration on psoriatic plaque |
|
| up to 6 weeks |
| Münster |
| Germany |
| University Hospital | Tübingen | Germany |