Moderate to severe chronic plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Almirall S.A.
Eligibility
Sex/Gender
All
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- Men or women must be at least 18 years of age at the time of the Screening Visit. 3- Patients with a diagnosis of chronic plaque psoriasis for at least 6 months prior to the Screening Visit. 4-Patient with a previous diagnosis of moderate-to-severe chronic plaque psoriasis who, at the Screening Visit, have at least moderate plaque psoriasis as defined in the Spanish proposal for moderate psoriasis as: a. PASI=7 or b. PASI1 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 at least 17 weeks after the last dose of tildrakizumab. 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. 10- 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1- Female patients who are currently pregnant, who intend to become pregnant (during the course of the study which included 17 weeks after the treatment), 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 psoriasis predominantly pustular psoriasis, medication-exacerbated psoriasis or new onset of guttate psoriasis). 3- Patients with current severe and/or uncontrolled psoriatic arthritis (PsA), or patients with PsA that are currently receiving systemic treatment (except those patients receiving NSAIDs and/or intra-articular injections of corticosteroids, which will be allowed). 4- Drug-induced psoriasis (i.e., a new onset or current exacerbation of psoriasis from betablockers, calcium channel blockers, or lithium) at the Screening Visit. 5- Patients with a history of sensitivity and/or allergy to any of the ingredients of the study medication. 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 (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. 8- History or evidence of skin disease (atopic dermatitis, psoriasis, eczema) or conditions (scarring, open wounds) other than the study indication that might interfere with the study conduct or evaluations, or which exposes the subject to unacceptable risk by study participation. 9- History of or current relevant autoimmune diseases (e.g. lupus-like syndromes) other than psoriasis. 10- Severe renal impairment (creatinine clearance 3x the upper limit of the normal range: aspartate amino transferase, alanine amino transferase, gamma-glutamyl-transferase, alkaline phosphatase. b. If bilirubin was >2x ULN, for the other liver enzymes >2x ULN was exclusionary 13- Patients with active infection disease or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalisation or treatment with IV antibiotics within 8 weeks prior to screening. 14- Active or latent tuberculosis (TB) at Screening visit. 15- Positive tes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1- To assess the efficacy of tildrakizumab 100 mg in the treatment of patients with moderate-to severe chronic plaque psoriasis at Week 24. 2- To assess the impact of tildrakizumab 100 mg on HRQoL (assessed by DLQI score) in patients with moderate-to-severe chronic plaque psoriasis at Week 24. ; Secondary Objective: 1- To assess the efficacy of tildrakizumab 100 mg on HRQoL (assessed by DLQI score and DLQI-R scores) in patients with moderate-to-severe chronic plaque psoriasis and to evaluate its correlation with other efficacy and HRQoL measures (to be described in the SAP). 2- To assess the efficacy of tildrakizumab 100 mg according to PASI, PGA and BSA scores in moderate-to-severe plaque psoriasis patients. 3- To assess the efficacy of tildrakizumab 100 mg according to Patient Reported Outcome (PRO) results (pruritus-VAS, pain-VAS, scaling-VAS, Skindex-16, MOS-Sleep, WPAI, patient´s treatment satisfaction [TSQM] and Patient Benefit Index [PBI]) in moderate-tosevere plaque psoriasis patients. 4- To assess the safety and tolerability of tildrakizumab 100 mg in moderate-to-severe plaque psoriasis patients. ; Primary end point(s): - Absolute PASI score and absolute change from baseline in the PASI scores at Week 24. - Absolute DLQI score and absolute change from baseline in the DLQI scores at Week 24. ;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints - Proportion of patients achieving absolute DLQI scores of 0-1 at Week 24. - Proportion of patients achieving absolute DLQI-R scores of 0-1 at Week 24. - Absolute DLQI score and absolute change from baseline in the DLQI scores at all visits*. - Absolute DLQI-R score and absolute change from baseline in the DLQI-R scores at all visits*. - Proportion of patients achieving absolute PASI scores of = 5, = 3, and = 1 at all visits*. - Absolute PASI score and absolute change from baseline in the PASI score at all visits*. - Absolute PGA score and absolute change from baseline in the PGA score at all visits*. - Proportion of patients achieving PGA scores of 0 or 1 with at least a 2-grade reduction from baseline at all visits*. - Absolute BSA score and absolute change from baseline in the BSA score at all visits*. - Absolute pruritus-NRS score and absolute change from baseline in the pruritus-NRS score at all visits*. - Absolute pain-NRS score and absolute change from baseline in the pain-NRS score at all visits*. - Absolute scaling-NRS score and absolute change from baseline in the scaling-NRS score at all visits*. - Absolute value and absolute change from baseline in the Skindex-16 questionnaire score at Week 24. - Absolute value and absolute change from baseline in the MOS-Sleep score at baseline and Week 24. - Absolute value and absolute change from baseline in WPAI score at Week 24. - Absolute TSQM score at Week 24. - Proportion of patients achieving a score = 1 in the absolute PBI score at Week 24. *When the variable will be collected Safety endpoints - Safety and tolerability as assessed by | — |
Countries
Italy, Spain
Contacts
Public ContactInternat. Clinical Trial Manager
Almirall S.A.
Outcome results
None listed