Study Complete
Sponsor ID
20200497

A comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

Sponsor ID
20200497
Clinicaltrials.gov ID
NCT05073315
EUCTIS ID
N/A
EudraCT ID
2021-000542-18

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.

Additional Study Details

Phase
Phase 3
Product
ABP 501
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
425
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Skin Search of Rochester, Inc.
Rochester, New York, United States, 14623
Status
Recruiting
Location
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States, 29407
Status
Completed
Location
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States, 37130
Status
Completed
Location
Austin Institute for Clinical Research - Dermatology
Houston, Texas, United States, 77056
Status
Completed
Location
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
Status
Completed
Location
Wilmington Dermatology Center
Wilmington, North Carolina, United States, 28405
Status
Recruiting
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