Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash).


Options:
A: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
B: Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 (Baseline, 16 hours post-dose on Day 28); Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 (Baseline, 16 hours post-dose on Day 28); Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 (Baseline, 16 hours post-dose on Day 28); Number of Participants With Change From Baseline in Physical Examinations (SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37); Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 (Baseline, 16 hours post-dose on Day 28); Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 (Baseline, 16 hours post-dose on Day 28); Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37); Number of Adverse Events (AEs) According to Severity (SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37); Number of Participants With Laboratory Abnormalities (SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37); Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28 (Baseline, 16 hours post-dose on Day 28); Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1); Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 (pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1); Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 (pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1)
C: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16); Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16)
D: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))

Answer: C