plaque psoriasis Psoriasis vulgaris
Conditions
Interventions
Eligible patients will receive DMF standard scheme from Baseline to Week 16
(Part 1 of the study). The DMF standard scheme will follow the guidance of the
SmPC posology. As such, in the first week,
Sponsors
TFS Trial Form Support BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Ability to understand and comply with the requirements of the study and communicate with the Investigator, and written, signed and dated informed consent given before any study related activity is performed. 2. Male or female, aged 18 years at the time of the Screening Visit. 3. Diagnosed with chronic plaque psoriasis of at least 6 months prior to the Screening Visit, and has stable active plaque-type psoriasis (stable is defined as without clinically significant flares during the 12 weeks before the Baseline Visit). 4. Moderate-to-severe plaque psoriasis at the Screening and Baseline visits as defined by PASI score of >= 10 5. Complete record of at least the last 12 months prior to the Screening Visit of anti-psoriatic previous topical, phototherapy and non-biologic systemic treatments, if any. 6. Candidate for systemic treatment for plaque psoriasis at the Screening Visit 7. General good health, or a stable medical condition not considered likely to interfere with the conduct of the clinical study, as determined by the Investigator based upon results of medical history, laboratory results (within normal or clinically acceptable range limits) and physical examination (no clinical significant abnormal findings). Investigators are encouraged to consult with the Sponsor if there are questions regarding the significance of any out of range values. 8. Unlikely to conceive, as indicated by at least one *yes* answer to the following questions: a. Patient is a male. b. Patient is a surgically sterilized female by hysterectomy or bilateral tubal ligation. c. Patient is a postmenopausal female >=45 years of age with >1 year since last menses. If a patient is 60 mIU/mL) at the Screening visit. d. Patient is a non-sterilized and pre-menopausal female using a highly effective medically accepted method of contraception, during the study period and for 4 or 17 weeks after the last dose of DMF or tildrakizumab respectively. Explanatory note: Highly effective methods of birth control are defined as a method with less than 1% failure rate (e.g. hormone implants, hormone injections, some intrauterine devices, vasectomized partner or sexual abstinence) or the use of two methods of contraception (e.g. one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectables and implants]) 9. For female patients of child-bearing potential, a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit. Additionally, they must agree to have urine pregnancy tests while on study medication.
Exclusion criteria
Exclusion criteria: 1. Female patients who are currently pregnant, who intend to become pregnant during the course of the study, or who are breastfeeding. Also if there is unwillingness/inability for the patients (women or men) to use appropriate measures of contraception (if necessary). 2. Current forms of psoriasis other than chronic plaque-type (e.g. erythrodermic, guttate, or pustular psoriasis) 3. Drug-induced psoriasis (i.e., a new onset or current exacerbation of psoriasis from beta-blockers, calcium channel blockers, or lithium) at the Screening Visit 4. History or evidence of skin disease (atopic dermatitis, eczema) or conditions (scarring, open wounds) other than chronic plaque-type psoriasis that might interfere with the study conduct or evaluations, or which exposes the patient to unacceptable risk by study participation 5. History of hypersensitivity or allergy to the study drugs or its excipients,which includes lactose*. *People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included in the study. 6. History of or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated). 7. History of or current relevant autoimmune diseases (e.g. lupus-like syndromes) other than psoriasis. 8. Active significant gastrointestinal problems (ulcers, diarrhoea, etc.) at the Screening Visit 9. Severe renal impairment (creatinine clearance 3x the upper limit of the normal range (ULN): aspartate amino transferase (AST; serum glutamic oxaloacetic transaminase [SGOT]), alanine amino transferase (ALT; serum glutamic pyruvic transaminase [SGPT]), gamma-glutamyl-transferase (GGT), alkaline phosphatase (ALP) b. If bilirubin was >2x ULN, for the other liver enzymes >2x ULN was exclusionary 12. Active infectious disease at the Screening Visit 13. Known positive test for human immunodeficiency virus or any other immunosuppressive disease 14. Known latent or active tuberculosis (TB) at the Screening visit 15. History (within 2 years prior to the Screening Visit) or evidence/indication of current drug and/or alcohol abuse or dependence, according to the judgment of the Investigator 16. Previous exposure to fumarate-based drug or a biologic systemic treatment (e.g. tumour necrosis factor-alpha inhibitors, IL-17 inhibitors, IL-17R inhibitors, IL-12/23 p40 inhibitors, IL-23p19 inhibitors or experimental biological product) 17 Have had a live vaccination within 4 weeks prior to the Baseline Visit, or intend to have a live vaccination during the course
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint (Part 2) Proportion of patients who were non-responders to DMF at Week 16 that were treated with Tildrakizumab and achieved a PASI 75 at week 40. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints (Part 1 and Part 2): Efficacy endpoints (Part 1) - Proportion of patients achieving PASI 50, PASI 75 and PASI 90 responses at Week 8 and Week 16 Visits of the Part 1 - Proportion of patients achieving absolute PASI scores of | — |
Countries
Netherlands
Outcome results
None listed