At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at screening
- ✓Chronic plaque psoriasis diagnosed ≥6 months ago
- ✓Moderate-to-severe scalp psoriasis: IGA ≥3, PSSI ≥12, ≥30% scalp surface area affected
- ✓Moderate-to-severe body psoriasis: PGA-S ≥3, PASI ≥12, BSA >10%
- ✕Non-plaque psoriasis forms: erythrodermic, pustular, medication-induced, or new-onset guttate psoriasis
- ✕Prior use of tildrakizumab or other IL-23/Th-17 pathway inhibitors (p40, p19, IL-17 antagonists)
- ✕Prior TNF-alpha inhibitor use capped at 40% of cohort; requires 12-week washout if used
- ✕Active or recurrent infection within 2 weeks (systemic antibiotics) or severe infection within 6 weeks (hospitalization/IV antibiotics)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Plaque Psoriasis of the Scalp
In Brief
A Phase 3 clinical trial evaluating PART 1: Double-blind Placebo-controlled and PART 2: Double-blind Active Treatment Extension for Scalp Psoriasis. Completed, enrolled 231 participants across 25 sites in 2 countries.
Detailed Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe psoriasis of the scalp.
Study Details
Timeline
Interventions
all eligible subjects will receive either tildrakizumab or placebo
subjects initially on placebo will be switched over to receive tildrakizumab while subjects initially on tildrakizumab will continue to receive tildrakizumab as per defined schedule