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
|ClinicalTrials.gov Identifier: NCT00570986|
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : February 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: Placebo Biological: ABT-874||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1465 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Placebo Comparator: 1
Arm #1 is used for entire study. At week 12, arm is rerandomized.
Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.
Active Comparator: 2
Arm #2 is used for entire study. At week 12, arm is rerandomized.
200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
Active Comparator: 3
Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.
100mg every 12 weeks.
- 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 ]
- DLQI [ Time Frame: Change from Baseline in DLQI total score vs. placebo at Week 12 ]
- NAPSI [ 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570986
Show 116 Study Locations
|Study Chair:||Martin Kaul, MD||AbbVie|