Moderate to Severe Plaque Psoriasis
Conditions
Keywords
Open label
Brief summary
The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.
Interventions
DRUGABT-874
100mg ABT-874 administered SQ every 4 wks for approximately 204 weeks
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Having participated in a preceding ABT-874 clinical trial for ABT-874 * Subject has a clinical diagnosis of moderate to severe plaque psoriasis
Exclusion criteria
* Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving PGA clear (0) or minimal (1) scores by visit. | Visit (12 weeks) |
| Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit. | Visit (12 weeks) |
| Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit. | Visit (12 weeks) |
| AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study | Visit (12 weeks) |
Countries
Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed