Treatment of pediatric subjects with moderate to severe chronic plaque psoriasis
Conditions
Brief summary
Part A • Pharmacokinetic parameters of tildrakizumab like observed maximum plasma concentration (Cmax), time to observed maximum plasma concentration in plasma (Tmax), area under the plasma concentration-time curve (AUC), half-life (T1/2), apparent volume of distribution (Vd/F) and clearance (CL)., Part B • The proportion of subjects with at least 75% improvement in the PASI score (PASI 75 response) from baseline at Week 16. • The proportion of subjects with PGA score of “clear” or “minimal” with at least a 2-grade reduction from baseline at Week 16.
Detailed description
Please refer to the enclosed protocol for more details regarding secondary endpoints.
Interventions
DRUGTildrakizumab matching placebo
DRUGTildrakizumab
DRUGEnbrel 25 mg powder for solution for injection
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A • Pharmacokinetic parameters of tildrakizumab like observed maximum plasma concentration (Cmax), time to observed maximum plasma concentration in plasma (Tmax), area under the plasma concentration-time curve (AUC), half-life (T1/2), apparent volume of distribution (Vd/F) and clearance (CL)., Part B • The proportion of subjects with at least 75% improvement in the PASI score (PASI 75 response) from baseline at Week 16. • The proportion of subjects with PGA score of “clear” or “minimal” with at least a 2-grade reduction from baseline at Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Please refer to the enclosed protocol for more details regarding secondary endpoints. | — |
Countries
Hungary, Poland, Slovakia, Spain
Outcome results
None listed