TABLE 1.
Comparison of the trial designs
| Study | Part 1 | Part 2 | Part 3 |
|---|---|---|---|
|
P05495 (phase 2b) N = 355 |
Weeks 0–16 tildrakizumab or placebo |
Weeks 16–52 tildrakizumab |
Weeks 52–72 follow up, treatment discontinued |
| ER, PK‐PD and safety analyses | PK‐PD analysis | PK‐PD analysis | |
|
reSURFACE 1 (phase 3) N = 772 |
Weeks 0–12 tildrakizumab or placebo |
Weeks 12–28 tildrakizumab |
Weeks 28–64 tildrakizumab or placebo |
| ER, PK‐PD and safety analyses | PK‐PD analysis | PK‐PD analysis | |
|
reSURFACE 2 (phase 3) N = 1090 |
Weeks 0–12 tildrakizumab, etanercept or placebo |
Weeks 12–28 tildrakizumab |
Weeks 28–52 tildrakizumab or placebo |
| ER, PK‐PD and safety analyses (except patients on etanercept) | PK‐PD analysis | PK‐PD analysis |
ER, exposure–response; PK‐PD, pharmacokinetic–pharmacodynamic.