An international, multicentre, open label, interventional phase IV clinical study to investigate the efficacy and safety of tildrakizumab 100 mg in patients with moderate-to-severe chronic plaque psoriasis and its impact on their quality of life

Phase 1

Conditions: Moderate to severe chronic plaque psoriasis
MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2019-002804-42-IT

Lead Sponsor: Almirall SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 177

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 psoriasis1 defined as:
a. PASI=10
or
b. Patients with involvement of sensitive area such as hands, palmoplantar, genital, scalp, face, and nails and a minimum baseline PASI of >7
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- Candidates eligible for systemic biologic treatment as assessed by the investigator.
7-Naïve patients to systemic biologic treatment (up to a maximum of 50% of the patients included) or having had a primary/secondary failure to treatment with one or more anti-TNF biologic agents for psoriasis.
Failure of anti-TNF therapy is defined as previous treatment with either infliximab, adalimumab and/or etanercept for at least 3 months without achieving PASI75 response, or a 50% loss of original improvement.
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 <45 years of age, or cessation of menses is more than 3 months and less than 1 year, follicle stimulating hormone must be documented as elevated into the postmenopausal range (>60 mIU/mL) at the Screening visit.
d. Patient is a non-sterilized and pre-menopausal female using a highly effective method of contraception, during the study period and for at least 17 weeks after the last dose of tildrakizumab.

...
PLEASE REFER TO THE STUDY PROTOCOL FOR THE COMPLETE LIST OF INCLUSION CRITERIA
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

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 beta-blockers, 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 patient 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 <30 mL/min, estimated glomerular filtration rate [eGFR] using CKD-EPI Creatinine Equation) or significant proteinuria (3+ or higher measured by dipstick) at the Screening Visit.
11- Any of the following haematological abnormality at the Screening Visit:
a. Platelet count < 100,000/mm3
b. White blood cell count < 3,000 cells/mm3,
c. Lymphocyte count <1,000/µl,
d. Haemoglobin, haematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the laboratory
12- Abnormal liver enzymes at the Screening Visit:
a. If an enzyme was >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.
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 test for human immunodeficiency virus or any other immunosuppressive disease.
16- Patients unlikely to be cooperative (e.g., take the medication, complete the Patient Diaries or attend the clinic at the required times).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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