| February 14, 2006 |
| July 1, 2008 |
| November 2005 |
| May 2008 (final data collection date for primary outcome measure) |
| Proportion of subjects with clinical response relative to Baseline PASI score [ Time Frame: Week 12, Week 40 and Week 60 ] [ Designated as safety issue: No ] |
| Proportion of subjects with clinical response relative to Baseline PASI score |
| Complete list of historical versions of study NCT00292396 on ClinicalTrials.gov Archive Site |
- Quality of Life Surveys [ Time Frame: Week 12, Week 48 and Week 60 ] [ Designated as safety issue: Yes ]
- Clinical response indicators [ Time Frame: Week 12, Week 48 and Week 60 ] [ Designated as safety issue: No ]
- Safety parameters [ Time Frame: Monthly through duration of study ] [ Designated as safety issue: Yes ]
- PGA Assessment [ Time Frame: Week 12, Week 40 and Week 60 ] [ Designated as safety issue: No ]
|
| QOLs, clinical response indicators, safety parameters |
| |
| Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
| A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
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 |
| |
| Phase II |
| Interventional |
| Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Psoriasis |
|
|
- 1: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks
Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
- 2: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks
Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
- 3: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks
Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
- 4: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks
Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
- 5: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks
Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
- 6: Placebo Comparator
placebo, 12 doses
Intervention: Drug: placebo
|
| Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008 Feb;144(2):200-7. |
| |
| Completed |
| 180 |
|
| May 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00292396 |
| Nicky Mayber, Abbott |
| M05-736 |
| Abbott |
|
| Study Director: |
Beverly Paperiello |
Abbott |
|
|
| Abbott |
| July 2008 |
