Treatment for plaque psoriasis patients. Skin and Connective Tissue Diseases
Conditions
Interventions
This randomized, double-blind, vehicle-controlled trial with safety run-in (part A) will investigate the safety, tolerability and efficacy of DLQ02, over four weeks to patients with plaque psoriasis.
Sponsors
Dermaliq Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant, non-lactating females. 2. 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 15cm2and =100cm2 with a severity defined by TSS score = 4, with at least a clinical score of = 2 for either erythema or induration and =1 for the symptom scaling. 6. 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. 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: 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): 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/cm2or >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 baseline 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 >2,5X 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 investigator, contraindicate participation in the trial or interfere with the outcome of the trial in the 4 weeks before the baseline visit and during the trial. 22. Have history of sensitivity to any of the study medications, or components thereof, or
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoints at baseline and at study visits (daily visits for one week followed by 1 visit per week for 4 weeks): 1. Cutaneous DLQ02 in skin biopsies. 2. Systemic levels of DLQ02. Pharmacodynamic and efficacy endpoints at baseline and at study visits 1. Severity of psoriasis target lesion using clinical assessments. 2. Percent of patients achieving clinical scores of clear of almost clear. 3. Score of individual symptoms of the target lesion 4. Patient reported outcomes of the target lesion Target lesion area assessed with: 5. 2D photography 6. 3D photography 7. Optical coherence tomography (OCT) 8. Laser speckle contrast imaging (LSCI) | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Target lesions scoring using PASI (part B) and target lesion total signs; erythema, induration and scaling at baseline and study visits (daily visits for one week followed by 1 visit per week for 4 weeks) 2. Patient reported itch as measured using NRS at baseline and at study visits 3. Diary as collected through eDiary at baseline and at study visits 4. Lesion size measured and documentation with 2D photography at baseline and study visits. 5. Lesion size measured using 3D photography at baseline and study visits. 6. Skin morphology using Optical Coherence Tomography at baseline and study visits. 7. Laser speckle contrast imaging at baseline and study visits. 8. Local irritation as measured using local irritation grading score (LIGS) at baseline and at study visits. | — |
Countries
Netherlands
Outcome results
None listed