A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
Condition(s) studied
Investigational drug(s) / intervention(s)
Tildrakizumab: Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)
Placebo: (Weeks 0 to 16)
Tildrakizumab: (Weeks 16 to 52)
Tildrakizumab: at every 12 weeks in open label fashion till 5 years (240 weeks).
Tildrakizumab: (Weeks 0 to 16)
Etanercept: (Weeks 0 to 16)
Placebo: (Weeks 16 to 52)
Study summary
The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE).
The initial PK analysis is first done in adolescent subjects (12 to \<18 years) before initiating the PK study in younger cohort (6 to \<12 years)
Eligibility
Primary outcome measure(s)
- Part A - Dose determination for pediatrics population 12 to <18-year-old age group — Up to week 16
- Part A - Dose determination for pediatrics population 6 to <12 year-old age group — Up to week 16
- Proportion of subjects with at least 75% improvement in the PASI response from baseline — Week 16
- Proportion of subjects with PGA score of "clear" or "minimal" with at least a 2-grade reduction from baseline — Week 16
- Number of subjects with adverse events — Week 16
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| Site 1 | Fountain Valley | California | |
| Site 2 | Thousand Oaks | California | |
| Site 20 | Miami | Florida | |
| Site 7 | Miami | Florida | |
| Site 14 | Spokane | Washington | |
| Site 63 | Budapest | Hungary | |
| Site 62 | Budapest | Hungary | |
| Site 61 | Debrecen | Hungary | |
| Site 64 | Kaposvár | Hungary | |
| Site 79 | Ahmedabad | India | |
| Site 71 | Lucknow | India | |
| Site 74 | Surat | India | |
| Site 57 | Bialystok | Poland | |
| Site 51 | Katowice | Poland | |
| Site 54 | Lodz | Poland | |
| Site 56 | Lodz | Poland | |
| Site 58 | Lublin | Poland | |
| Site 50 | Ostrowiec Świętokrzyski | Poland | |
| Site 59 | Sosnowiec | Poland | |
| Site 52 | Szczecin | Poland | |
| Site 53 | Warsaw | Poland | |
| Site 39 | Wroclaw | Poland | |
| Site 92 | Bardejov | Slovakia | |
| Site 91 | Svidník | Slovakia | |
| Site 90 | Trnava | Slovakia | |
| Site 41 | Barcelona | Spain | |
| Site 47 | Las Palmas de Gran Canaria | Spain |
On this site
📄 Enbrel (etanercept) drug profile →More Sun Pharmaceutical Industries Limited trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03997786 on ClinicalTrials.gov ↗ ← All trials in Spain