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
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570986
|Study Chair:||Martin Kaul, MD||AbbVie|