A multi-center, blinded, randomized study to assess the safety, tolerability and efficacy of an application of DLX105 onto affected skin in comparison to placebo in patients with mild-to-moderate psoriasis vulgaris

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 54

Inclusion Criteria

Patients eligible for inclusion in this trial have to fulfil all of the following criteria:
1.Signed and dated informed consent prior to initiation of any study procedures.
2.Male or female Caucasian aged 18-75 years.
3.Male or female patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI =15).
4.Male or female Caucasian patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI =15) aged 18-75 years who must have at least two psoriasis lesions of >9 cm2 (located at arms and/or trunk, excluding elbows and legs), stable for at least 3 months, local PASI score =8.
5.Affected body surface area (BSA) =10%.
6.Negative pregnancy test for females of child-bearing potential (pre-menopausal,
<2 years post-menopausal, not surgically sterile).
7.Willing and able to participate in the trial as an outpatient and comply with all trial requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients who fulfil one or more of the following criteria will not be eligible for inclusion in this trial:
1.Forms of psoriasis other than chronic plaque-type only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, plantar or nail disease) at screening.
2.Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) prior to randomization
3.Ongoing use of prohibited psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
a.Biological agents, e.g. adalimumab, etanercept, infliximab, ustekinumab, alefacept (12 weeks)
b.Systemic therapy for psoriasis and psoriatic arthritis (other than above) e.g. methotrexate, cyclosporin, fumaric acid (derivatives), systemic steroids (4 weeks)
c.Photochemotherapy e.g., ultraviolet A with psoralen (PUVA) (4 weeks)
d.Phototherapy e.g., ultraviolet A (UVA) or ultraviolet B (UVB) (2 weeks)
e.Topical therapies for the treatment of Ps such as corticosteroids, vitamin D analogues or retinoids within 14 days prior to baseline
f.Other investigational psoriasis drugs (4 weeks or 5 half-lives, whichever is longer)
4.Intake of any investigational drug or participation in a Clinical Trial within 4 weeks or 5 half-lives, (whichever is longer) prior to baseline.
5.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.
6.Active systemic infections (other than common cold) during the two weeks before randomization
7.Positive test for hepatitis B or C at screening
8.Positive test for HIV at screening
9.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.
10.History of severe hypersensitivity to any human or humanized biological agents
11.Any severe, progressive or uncontrolled medical condition at baseline that in the judgment of the investigator prevents the patient from participating in the study.
12.Any clinically significant abnormal laboratory tests at screening
13.Active liver disease with alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 3 x upper limit of normal at screening
14.History of moderate or severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
15.Inability or unwillingness to undergo repeated venipunctures (e.g., due to poor tolerability or lack of access to veins)
16.History or evidence of drug or alcohol abuse within the 6 months prior first study drug administration
17.Patients who had live vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial
18.History of hypersensitivity to any of the excipients of the study drugs or to excipients of similar chemical classes
19.Pregnant or nursing (lactating) women, where pregnancy is d

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials