An open-label, randomized, Phase IV study, to assess the efficacy and safety of tildrakizumab in patients with moderate to severe chronic plaque psoriasis who are non-responders to dimethyl fumarate therapy - TRANSITION study

Almirall0 sites250 target enrollmentAugust 1, 2019

ConditionsModerate 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]

DrugsIllumetri Skilarence

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to severe chronic plaque psoriasis
Sponsor: Almirall
Enrollment: 250
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 1, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Almirall

Eligibility 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.

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 include lactose\*
•\* People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose 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 \<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.