Psoriasis
Conditions
Keywords
ABBV-066, BI 655066
Brief summary
The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.
Interventions
DRUGrisankizumab
subcutaneous (SC) injection
DRUGmethotrexate
capsule
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of plaque psoriasis (with or without concurrent psoriatic arthritis) for at least 6 months before the first administration of study drug * Have stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline Visits * Be a candidate for systemic therapy for plaque psoriasis as assessed by the investigator * Be a candidate for treatment with methotrexate (MTX) according to local label
Exclusion criteria
* Subjects with non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment * Previous exposure to risankizumab * Previous exposure to MTX * Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator * Subject has a history of clinically significant hematologic, renal, or liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28. | Week 28 | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. |
| Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28 | Week 28 | PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28 | Week 28 | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. |
| Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28 | Week 28 | PASI100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part. |
| Achievement of an increase of 0.1 or more points from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) at all visits | Week 28 | The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. |
| Change from baseline in EQ-5D-5L at all visits collected | Week 28 | The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. |
| Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28 | Week 28 | PASI75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part. |
Countries
Brazil
Outcome results
None listed