| December 7, 2007 |
| June 29, 2009 |
| December 2007 |
| June 2009 (final data collection date for primary outcome measure) |
- PGA [ Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12 ] [ Designated as safety issue: No ]
- PASI [ Time Frame: Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12 ] [ Designated as safety issue: No ]
- PGA [ Time Frame: Proportion of subjects maintaining a PGA 0/1 response at Week 52 ] [ Designated as safety issue: No ]
|
- PGA [ Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12 ]
- PASI [ Time Frame: Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12 ]
- PGA [ Time Frame: Proportion of subjects maintaining a PGA 0/1 response at Week 52 ]
|
| Complete list of historical versions of study NCT00570986 on ClinicalTrials.gov Archive Site |
- DLQI [ Time Frame: Change from Baseline in DLQI total score vs. placebo at Week 12 ] [ Designated as safety issue: No ]
- NAPSI [ Time Frame: % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis ] [ Designated as safety issue: No ]
- PASI [ Time Frame: Subjects who achieve PASI 90 and 100 at Week 12 ] [ Designated as safety issue: No ]
- Safety parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
|
- DLQI [ Time Frame: Change from Baseline in DLQI total score vs. placebo aat Week 12 ]
- mNAPSI [ Time Frame: % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis ]
- PASI [ Time Frame: Subjects who achieve PASI 90 and 100 at Week 12 ]
- Safety parameters [ Time Frame: Throughout study ]
|
| |
| A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
| A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
Safety and efficacy of ABT-874 in the treatment of moderate to severe plaque psoriasis two doses of ABT-874 versus placebo |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Plaque Psoriasis |
- Drug: Placebo
- Biological: ABT-874
|
- Placebo Comparator: Arm #1 is used for entire study. At week 12, arm is rerandomized.
- Active Comparator: Arm #2 is used for entire study. At week 12, arm is rerandomized.
- Active Comparator: Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.
|
| |
| |
| Completed |
| 1465 |
|
| June 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subject is >= 18 years of age
- Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
- Subject is judged to be in generally good health as determined by the principal investigator
Exclusion Criteria:
- Subject has previous exposure to systemic 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 injectible corticosteroids
- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
- Subject considered by the investigator, for any reason, to be an unsuitable candidate
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00570986 |
| Beverly Paperiello, Director, Immunology Development, Abbott |
| M06-890 |
| Abbott |
|
| Study Director: |
Joaquin Valdes, MD |
Abbott |
|
|
| Abbott |
| June 2009 |
