mild-to-moderate plaque-type psoriasis vulgaris 6 (PASI =15) MedDRA version: 17.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
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
Concent
Sponsors
Delenex Therapeutics AG
Eligibility
Sex/Gender
All
Inclusion criteria
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, =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Primary
| Measure | Time frame |
|---|---|
| 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 ;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.;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. ;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 | — |
Countries
Austria, Germany
Contacts
Public ContactClinical Trial Operations
Delenex Therapeutics AG
Outcome results
None listed