MSB11022 in Moderate to Severe Chronic Plaque Psoriasis (NCT02660580) | Clinical Trial Compass
CompletedPhase 3
MSB11022 in Moderate to Severe Chronic Plaque Psoriasis
United States443 participantsStarted 2016-02-16
Plain-language summary
The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female participants greater than or equal to (\>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index \[PASI\] score \>=12, Physician Global Assessment \[PGA\] 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
* Participants must not have received more than 1 biologic therapy
* Other protocol-defined inclusion criteria could apply
Exclusion Criteria:
* Participants was 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
* Participants 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 investigational medicinal product (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
* Participants was excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis \[TB\]); history of active T…
What they're measuring
1
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16