moderate to severe plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subjects =18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by PASI score =12, PGA score =3, and =10% of body surface area affected at Screening and Baseline [Day 1 of Week 1]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque-type psoriasis despite topical therapy. Subjects must not have received more than 1 biologic therapy with either etanercept or infliximab (etanercept must be stopped at least 30 days and infliximab must be stopped at least 60 days prior to randomization). - Other protocol-defined inclusion criteria could apply 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 383 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: -Subjects will be excluded if they have erythrodermic, pustular, guttate, or medication-induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis. Subjects must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of IMP administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration. - Subjects will also be excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent TB); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex. - Subjects will be excluded if they have a body weight >120 kg. - Other protocol defined exclusion criteria could apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to demonstrate equivalence in efficacy of MSB11022 in subjects with moderate to severe chronic plaque psoriasis.;Primary end point(s): Number of subjects with PASI 75 (Psoriasis Area and Severity Index score reduction of =75% from Baseline);Timepoint(s) of evaluation of this end point: at week 16; Secondary Objective: - To assess the similarity in efficacy of treatment with MSB11022 in subjects with moderate to severe chronic plaque psoriasis. - To assess safety and immunogenicity of MSB11022 in subjects with moderate to severe chronic plaque psoriasis. - To describe pharmacokinetic (PK) data on MSB11022 in subjects with moderate to severe chronic plaque psoriasis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint: Percent change from baseline in PASI (Psoriasis Area and Severity Index). ;Timepoint(s) of evaluation of this end point: Key secondary endpoint will be evaluated at week 16. | — |
Countries
Bulgaria, Canada, Czech Republic, Estonia, France, Germany, Hungary, Mexico, Poland, Romania, Russian Federation, United Kingdom, United States
Contacts
Public ContactCommunication Center Merck KGaA
Merck KGaA
Outcome results
None listed