Study Complete
Sponsor ID
20200417
A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis
Study Details
The purpose of the study is to evaluate pharmacokinetic similarity, efficacy, safety and immunogenicity of multiple switches between ustekinumab and ABP 654 compared with continued use of ustekinumab in participants with moderate to severe plaque psoriasis.
Protocol Summary
Primary Outcome Measures
Area Under the Curve from Time 0 over the Dosing Interval (AUCtau)
Timeframe: Week 52 (pre-dose and post-dose) until Week 64
Maximum Concentration (Cmax)
Timeframe: Week 52 (pre-dose and post-dose) until Week 64
Secondary Outcome Measures
Time of Maximum Concentration (tmax)
Timeframe: Week 52 (pre-dose and post-dose) until Week 64
Trough Concentration at Steady State (Ctrough,ss)
Timeframe: Week 28 (pre-dose and post-dose) until Week 52 (pre-dose and post-dose)
Percent Improvement in PASI From Baseline to Week 64
Timeframe: Baseline (Day 1) until Week 64
Percentage of Participants with PASI 75 Response at Week 64
Timeframe: Week 64
Percentage of Participants with PASI 100 Response at Week 64
Timeframe: Week 64
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Timeframe: Week 28 until Week 64
Number of Participants With Events of Interest
Timeframe: Week 28 until Week 64
Number of Participants With Positive Anti-drug Antibodies to ABP 654
Timeframe: Week 28 until Week 64 (Pre-dose)
Locations
Location
Skin Specialists PC
Omaha, Nebraska, United States, 68144
Status
Recruiting
Location
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, United States, 33028-1013
Status
Completed
Location
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Status
Recruiting
Location
Advanced Medical Research PC
Sandy Springs, Georgia, United States, 30328
Status
Recruiting
Location
Oregon Medical Research Center
Portland, Oregon, United States, 97223
Status
Recruiting
Location
Austin Institute for Clinical Research, Inc.
Dripping Springs, Texas, United States, 78620
Status
Recruiting
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