At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Chronic plaque-type psoriasis for at least 6 months
- ✓PASI score between 6 and 12 with BSA <10% affected by plaque-type psoriasis at screening and baseline
- ✓Negative TB testing (negative PPD or negative QuantiFERON-TB Gold)
- ✕Non-plaque forms of psoriasis (erythrodermic, guttate, pustular)
- ✕Prior treatment with secukinumab or other biologics
- ✕History of Inflammatory Bowel Disease (IBD)
- ✕History of Rheumatoid Arthritis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Secukinumab in Adults With Chronic Plaque Type Psoriasis With a PASI Score of 6 to 12
In Brief
A Phase 2 clinical trial evaluating Secukinumab and Placebo followed by Secukinumab for Psoriasis. Completed, enrolled 23 participants across 1 site.
Detailed Summary
Mild psoriasis not only progresses to moderate-to-severe psoriasis but also precedes systemic inflammation that leads to psoriatic arthritis and cardiovascular comorbidities. By curing mild psoriasis with a short-term anti- interleukin (IL)-17A treatment, investigators may reduce the costs of treating psoriasis and associated medical conditions, including psoriatic arthritis, cardiovascular disease, and diabetes.
Study Details
Timeline
Interventions
Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).