A comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
Study Details
Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.
Protocol Summary
Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of Adalimumab and ABP 501
Timeframe: Week 28 (Pre-dose and Post-dose) through Week 30
Maximum Concentration (Cmax) of Adalimumab and ABP 501
Timeframe: Week 28 (Pre-dose and Post-dose) through Week 30
Time of Maximum Concentration (tmax) of Adalimumab and ABP 501
Timeframe: Week 28 (Pre-dose and Post-dose) through Week 30
Trough Concentration (Ctrough) of Adalimumab and ABP 501
Timeframe: Week 14 through Week 28 (Pre-dose and Post-dose)
Percent Improvement in PASI From Baseline to Week 30
Timeframe: Baseline (Day 1) through Week 30
Percentage of Participants with PASI 75 Response at Week 30
Timeframe: At Week 30
Percentage of Participants with PASI 90 Response at Week 30
Timeframe: At Week 30
Percentage of Participants with PASI 100 Response at Week 30
Timeframe: At Week 30
Number of Participants With Treatment Related Adverse Events (TEAEs)
Timeframe: From Screening (≤ 28 days) through Week 32 or End of Study
Number of Participants With Events of Interest
Timeframe: From Screening (≤ 28 days) through Week 32 or End of Study
Percentage of participants with Anti-drug Antibodies (ADA)/Neutralizing Antibodies (Nab) over time
Timeframe: Baseline (Day 1) through Week 32 (Pre-dose) or End of Study