Skip to main content
. 2017 Mar 8;57(7):876–885. doi: 10.1002/jcph.876

Table 1.

Secukinumab clinical studies constituting the PK analysis data set

Study Primary Objective Design Treatment Regimensa PK Sampling Mean Age of Patients Receiving Secukinumab
Proof of concept, Hueber et al23 Efficacy Randomized, double‐blind, parallel‐group, placebo‐controlled Single dose (n = 36)

  • Placebo (n = 18)

  • Secukinumab 3 mg/kg intravenously (n = 18)

 Predose, end of infusion, 1 and 2 h after infusion, then at weeks 1, 2, 3, 4, 5, 6, 8, and 12 50.7 years
Absolute bioavailability study Bioavailability Randomized, open‐label, crossover Multiple doses (n = 14)

  • Secukinumab 1 × 1 mg/kg intravenously on day 1 followed by 1 × 150 mg subcutaneously on day 29 (n = 7)

  • Secukinumab 1 × 150 mg subcutaneously on day 1 followed by 1 × 1 mg/kg intravenously on day 29 (n = 7)

 For intravenous: predose and 1, 2, 4, and 8 h; for subcutaneous: predose and 1 and 8 h; and then 1, 3, 4, 7, 9, 14, 21, 28, 29, 31, 32, 35, 38, 42, 49, 56, 70, and 84 days after first dose for both arms 46.8 years
Phase 2 dose‐regimen‐finding study, Rich et al24 Efficacy Randomized, double‐blind, parallel‐group, placebo‐controlled Multiple doses (n = 404)

  • Placebo (n = 67)

  • Secukinumab 1 × 150 mg subcutaneously (n = 66)

  • Secukinumab 150 mg subcutaneously every 4 weeks (n =138)

  • Secukinumab 150 mg subcutaneously at weeks 0, 1, 2, and 4 (n = 133)

 Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24, 28, and 32 42.7–44.5 years
Extension of dose‐regimen‐finding study Long‐term safety, tolerability Open‐label extension Multiple doses, maintenance

  • Responders: secukinumab 150 mg subcutaneously at weeks 12, 24, or start of relapse

  • Nonresponders and partial responders: open‐label secukinumab 150 mg subcutaneously every 4 weeks

 Weeks 12, 24, and 36 39.9–45.0 years
Phase 2 dose‐finding‐study, Reich et al27 Efficacy Randomized, double‐blind, parallel‐group, placebo‐controlled Single and multiple doses (n = 100)

  • Placebo (n = 10)

  • Secukinumab 1 × 3 mg/kg intravenously (n = 30)

  • Secukinumab 1 × 10 mg/kg intravenously (n = 29)

  • Secukinumab 3 × 10 mg/kg intravenously (n = 31)

 Predose and 2 and 4 h after infusions at weeks 1, 2, and 4; additional sampling at weeks 1, 6, 8, 10, 12, 16, 20, 24, 28, 32, 40, 48, and 56 43.4–45.7 years
Phase 2 dose‐finding‐study, Papp et al15 Efficacy Randomized, double‐blind, parallel‐group, placebo‐controlled Single and multiple doses (n = 125)

  • Placebo (n = 22)

  • Secukinumab 1 × 25 mg subcutaneously (n = 29)

  • Secukinumab 25 mg subcutaneously every 4 weeks (n = 26)

  • Secukinumab 75 mg subcutaneously every 4 weeks (n = 21)

  • Secukinumab 150 mg subcutaneously every 4 weeks (n = 27)

 Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36 45.4–46.3 years
Phase 3 ERASURE study, Langley et al9 Efficacy superiority vs. placebo Randomized, double‐blind, parallel‐group, placebo‐controlled Multiple doses (n = 738)

  • Placebo (n = 248)

  • Secukinumab 150 mg subcutaneously at baseline; weeks 1, 2, and 3; and then every 4 weeks from week 4 to week 48 (n = 245)

  • Secukinumab 300 mg subcutaneously at baseline; weeks 1, 2, and 3; and then every 4 weeks from week 4 to week 48 (n = 245)

 Predose, baseline, and weeks 4, 12, 24, and 52 44.9 years
Phase 3 FIXTURE study,b Langley et al9 Efficacy superiority vs. placebo Randomized, double‐blind, double‐dummy, placebo‐controlled Multiple doses (n = 1306)

  • Placebo (n = 326)

  • Etanercept (n = 326)

  • Secukinumab 150 mg subcutaneously at baseline; weeks 1, 2, and 3; and then every 4 weeks from week 4 to week 48 (n = 327)

  • Secukinumab 300 mg subcutaneously at baseline; weeks 1, 2, and 3; and then every 4 weeks from week 4 to week 48 (n = 327)

 Predose, baseline, and weeks 4, 12, 24, and 52 44.5–45.4 years

ERASURE, Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis; FIXTURE, Full‐Year Investigative Examination of Secukinumab vs. Etanercept Using 2 Dosing Regimens to Determine Efficacy in Psoriasis; PD, pharmacodynamic; PK, pharmacokinetic.

a

Patient numbers reported in this table are the number of enrolled patients for each study.

b

Results from FIXTURE were used as an external validation data set. The PK analysis set includes only the patients with evaluable PK data.