A multi-center, double-blinded, randomized, placebo-controlled, phase II study to evaluate the safety, tolerability and efficacy of a topical application of DLX105 onto lesional skin in patients with mild-to-moderate psoriasis vulgaris

INTERVENTION: Product Name: DLX105 Pharmaceutical Form: Gel INN or Proposed INN: humanized single‐chain antibody fragment for TNF‐alpha inhibition Current Sponsor code: DLX105 Other descriptive name: DLX105 Concentration unit: % percent Concentration type: equal Concentration number: 0,5‐ Pharmaceutical form of the placebo: Gel Route of administration of the placebo: Topical use (Noncurrent) CONDITION: mild‐to‐moderate plaque‐type psoriasis vulgaris 6 (PASI =15) ; MedDRA version: 16.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858 Therapeutic area: Body processes [G] ‐ Cell Physiological Phenomena [G04] PRIMARY OUTCOME: Main Objective: • To investigate the safety and tolerability of DLX105 administered topically onto the psoriatic lesion of mild‐to‐moderate psoriatic patients ; ; • To determine the efficacy of a formulation of DLX105 administered topically, measured by local PASI scores at two different plaques at wk4 compared to baseline; Primary end point(s): Safety:; • Evaluation of local tolerability of topical administration of DLX105 in mild‐to moderate psoriatic patients, measured by patients (VAS) and investigators (validated score) for each treatment area.; • Evaluation of treatment‐related adverse events (AEs); • Detection of anti‐drug antibodies (ADAs). Assessment of immunogenic potential of topically administered DLX105 by ELISA with coated DLX105 to capture anti‐DLX105 antibodies ; ; Efficacy:; • Evaluation of clinical signs of activity to local administration of DLX105 measured by local PASI score per treatment area at week 4 compared to baseline, in mild‐to‐moderate psoriatic patients.; • Assessment of the difference of clinical signs of activity to local administration of DLX105 compared to placebo, measured by local PASI score per treatment area at week 4. ; Secondary Objective: • To determine the pharmacokinetics (PK) and Immunogenicity of DLX105 upon topical application onto the psoriatic lesion of mild‐to‐moderate psoriatic patients; ; • To evaluate the impact of weekly pre‐treating psoriatic skin by tape‐stripping on the clinical response ; ; exploratory:; • To evaluate biomarkers (such as TNF‐alpha, IL‐17, IL‐23, epidermal thickness, Ki67 expression) in skin biopsies. Timepoint(s) of evaluation of this end point: Safety:; investigator's assessment of tolerability: Visit 2 (baseline) to visit 8 (week 6, follow‐up, end of study), weekly visits except visit 8 (2 weeks after visit 7 (last treatment)); ; patient's assessment of tolerability: visit 2 to visit 7; ; Efficacy:; local PASI (SOS): visit 2, visit 4 to visit 8; photo documentation: visit 2, visit 7 SECONDARY OUTCOME: Secondary end point(s): Efficacy; • Evaluation of clinical signs of activity to local administration of DLX105 measured by local PASI score per treatment area at week 6 compared to baseline, in mild‐to‐moderate psoriatic patients.; • Assessment of the difference of clinical signs of activity to local administration of DLX105 compared to placebo, measured by local PASI score per treatment area at week 6.; • Evaluation of impact of weekly pre‐treating psoriatic skin by tape‐stripping on the clinical response, measured by difference of local PASI score between pre‐treated and non‐pre‐treated areas at week 4 in mild‐to‐moderate psoriatic patients.; Timepoint(s) of evaluation of this end point: visit 2 (baseline), visit 7 (last treatment), visit 8 (week 6, follow‐up, end of study) 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 subjec