Study Complete
Sponsor ID
20200417

A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis

Sponsor ID
20200417
Clinicaltrials.gov ID
NCT04761627
EUCTIS ID
N/A
EudraCT ID
2020-005205-42

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
494
Additional Study Details

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
Status
Contact Us
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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