Clinical trial
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis (GESTURE)
Primary Outcome Measures:
- Efficacy:palmoplantar Investigator Global Assessmnet (ppIGA) response after 16 weeks of treatment. Each of the treatment groups will be compared to placebo. [ Time Frame: Baseline, 16 weeks ]
Primary endpoint is the palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.
Secondary Outcome Measures:
- Efficacy: palmoplantar Investigator Global Assessment (ppIGA) response over time up to Week 16, and over time up to Week 80 or Week 132 [ Time Frame: 16 weeks, 132 weeks ]
The ppIGA scores signs of plaque psoriasis on the palms and soles. A subject is considered ppIGA responder at specific points in time if the ppIGA score at the time of assessment is 0 or 1 AND if at that time, there is a reduction from baseline of at least 2 points on the ppIGA scale. Response to treatment will be assessed in each secukinumab group over time up to Week 16 in comparison with placebo, and over time until Week 132.
- Efficacy: palmoplantar Psoriasis Area and Severity Index (ppPASI) over time up to Week 16 compared to placebo, and over time up to Week 132 [ Time Frame: 16 weeks, 132 weeks ]
The ppPASI score evaluates erythema, induration and desquamation, as well as the affected area of palms and soles. Percentage change in ppPASI score from baseline will be assessed in each secukinumab group over time up to Week 16 in comparison with placebo, and over time up to Week 132.
- Number of subjects in treatment groups 150mg and 300mg with adverse events, safety labs, ECG, and vital signs as a measure of safety and tolerability [ Time Frame: Baseline, up to 140 weeks ]
Adverse events, safety labs, ECG and vital signs will be used to assess safety and tolerability of the study treatment in patients who took at least one dose.
- Number and percentage of subjects who develop immunogenicity against secukinumab [ Time Frame: Baseline, 32 weeks, 80 weeks, 132 weeks, 88 weeks or 140 weeks ]
Overall statistics will be used to assess the immunogenicity of secukinumab. Patients who discontinue treatment after Week 80 will have the last immunogenicity test performed at Week 88, all other patients - at Week 140.
| Category | Value |
|---|---|
| Date last updated at source | 2017-02-26 |
| Study type(s) | Interventional |
| Expected enrolment | 205 |
| Study start date | 2013-06-19 |
| Estimated primary completion date | 2016-11-02 |