Plaque Psoriasis
Conditions
Interventions
DLQ02 is a liquid topical drug product with CsA as active. In this study two
Cyclosporine concentrations (0.2% and 1.0%) will be assessed.
Sponsors
Dermaliq Therapeutics Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must: 1) Be males or non-pregnant, non-lactating females. 2) Be at least 18 years of age at time of consent. 3) Have stable psoriatic plaque psoriasis (for >= 6 months), as confirmed by the patient. 4) Have a maximum (treatable) BSA of 2.5% (only part B) 5) Have a target plaque (area) suitable for treatment >=15cm2 and = 4, with at least a clinical score of >= 2 for either erythema or induration and >=1 for the symptom scaling. 6) Be able and willing to follow instructions and comply with the study restrictions, including participation in all trial assessments and visits. 7) Provide written informed consent. 8) Be willing to refrain from medications for psoriasis according to the wash-out periods. 9) Patients and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
Exclusion criteria
Exclusion criteria: Patients must not: 1) Have any current and / or recurrent clinically significant skin condition which will interfere with the clinical findings of the study as assessed by the investigator. 2) Have a current diagnosis of psoriasis other than plaque psoriasis (including guttate psoriasis, psoriasis erythroderma and pustular psoriasis). 3) Use the following psoriasis medications. Wash-out periods are stated below. • Local treatment of plaques with anti-psoriatics (e.g., vitamin D analogs, corticosteroids, retinoids, tacrolimus or other calcineurin inhibitors excepting CsA (prohibited): 2 weeks prior to baseline. • Emollients or scale-softening treatments on target plaques (including salicylic acid): from baseline onwards. 4) Have a current systemic treatment with psoriasis medication (e.g. retinoids and immunomodulating drugs such as methotrexate and tacrolimus, CsA or a treatment with biologic.) 5) Begin treatment with systemic or locally acting medications which might counter or influence the study aim (e.g., medications which are known to provoke or aggravate psoriasis including but not limited to antimalarial drugs, beta-blockers [e.g., propanolol], lithium, iodides, angiotensin-converting enzyme inhibitors, nifepidine, indomethacin, ciprofloxacin, and diphenhydramine) prior to baseline (therapy with stable dose is allowed). 6) Begin treatment with CYP3A4 interactive drugs [e.g., miconazole, ketoconazole, erythromycin, clarithromycin, diltiazem, ritonavir, verapamil, grapefruit]. 7) Have history of PUVA if >1000 J/cm2 or >200 cumulative treatments. 8) Have participated in a clinical research trial within 90 days, or 5 half-lives of the investigational product, whichever is greater, prior to screening visit. 9) Be study site employees, or immediate family members of a study site or sponsor employee. 10) Have prolonged exposure to UV light within two weeks prior to study day 1 or intention to have such exposures during the study. 11) Have a history of drug abuse within the past two years. 12) Regular alcohol consumption in males >21 units per week and females>14 units per week (1 unit approximately 240 ml of beer, 25 ml of 40% spirit or a 125 ml glass of wine), or a history of alcohol abuse within the past two years. 13) Change smoking habits during the 4 weeks prior to study start or during the study; smokers are allowed up to 6 cigarettes per day if smoking is a current habit. 14) Have clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator. 15) Have liver function tests (ALT, AST, GGT, ALP) range >2.5 X upper limit of normal of each parameter at screening. 16) Have a clinically significant abnormal renal function (including any stage of chronic kidney disease). 17) Have positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) results. 18) Have live vaccination during the study or in the 2 weeks before study start. 19) Have vaccination for SARS-CoV-2 within 14 days prior to initial dosing, or planned during the course of the study. 20) Have history of malignancy, except adequately treated non-invasive skin cancer (basal or squamous cell carcinoma). 21) Have clinically significant illness or infection that may, in the opinion of the i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability / safety endpoints 1) Adverse events (AE) 2) Laboratory safety testing (blood and urine) 3) 12-lead ECGs 4) Vital signs 5) Physical examination 6) Systemic levels of CsA and the novel excipient F6H8 7) Skin irritation of non-lesional skin by local irritation grading scale (LIGS) (Part A only) Adherence Electronic diary with photo capture function to monitor treatment compliance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoints 1) Cutaneous PK in skin biopsies. 2) Systemic levels of CsA and the novel excipient F6H8 Pharmacodynamic and efficacy endpoints 1) Severity of psoriasis target lesion after 1, 2, 3 and 4 weeks of treatment using clinical assessment of signs (erythema, induration, scaling) expressed as TSS (Total Sum Score) 2) Percent of patients achieving clinical scores of the target lesion of clear (score of 0 for each symptom) or almost clear (erythema, induration and scaling each | — |
Countries
Netherlands
Outcome results
None listed