Psoriasis
Conditions
Brief summary
The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.
Interventions
DRUGAnti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
DRUGplacebo
12 doses
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history. * Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
Exclusion criteria
* Subject had previously received systemic or biologic anti-IL-12 therapy * Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy * Subject is taking or requires oral or injectable corticosteroids * Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study * Female subject who is pregnant or breast-feeding or considering becoming pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with clinical response relative to Baseline PASI score | Week 12, Week 40 and Week 60 |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Surveys | Week 12, Week 48 and Week 60 |
| Clinical response indicators | Week 12, Week 48 and Week 60 |
| Safety parameters | Monthly through duration of study |
| PGA Assessment | Week 12, Week 40 and Week 60 |
Countries
Canada, United States
Outcome results
None listed