Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis
Brief Summary: The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.


Options:
A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)
B: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
C: Change in Vascular Inflammation (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Vascular Inflammation (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Total Cholesterol (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Cholesterol Efflux (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Insulin (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Adiponectin (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Leptin (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log C-reactive Protein (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Interleukin 6 (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - GlycA (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarkers: - Total Cholesterol (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Cholesterol Efflux (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Insulin (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Adiponectin (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Leptin (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log C-reactive Protein (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Interleukin 6 (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - GlycA (52 weeks of adalimumab treatment)
D: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16); Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 (Week 16)

Answer: D