Study Complete
Sponsor ID
20190232

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

Sponsor ID
20190232
Clinicaltrials.gov ID
NCT04607980
EUCTIS ID
N/A
EudraCT ID
2020-003184-25

Study Details

The purpose of the study is to evaluate the efficacy, safety, and immunogenicity of ABP 654 compared with ustekinumab in participants with moderate to severe plaque psoriasis.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
563
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent Improvement in PASI From Baseline to Week 12

Timeframe: Baseline (Day 1 [Week 0]) until Week 12

Secondary Outcome Measures

Percent Improvement in PASI at Other Timepoints

Timeframe: Baseline (Day 1 [Week 0]), weeks 4, 12, 16, 28, 36, 40, 44 and Week 52 (end of study [EOS])

Percentage of Participants with PASI 75 Response Throughout the Study

Timeframe: Baseline (Day 1 [Week 0]), weeks 4, 12, 16, 28, 36, 40, 44 and Week 52 (EOS)

Percentage of Participants with PASI 100 Response Throughout the Study

Timeframe: Baseline (Day 1 [Week 0]), weeks 4, 12, 16, 28, 36, 40, 44 and Week 52 (EOS)

Percentage of Participants With Static Physician’s Global Assessment (sPGA) Responses (0/1) at Week 12 and Week 52

Timeframe: Week 12 and Week 52

Change From Baseline in Percentage of Body Surface Area (BSA) Affected with Psoriasis at Week 12 and Week 52

Timeframe: Week 12 and Week 52

Number of participants With Treatment Emergent Adverse Events and Serious Adverse Events

Timeframe: From Screening Day until Week 52 (EOS)

Events of Interests (EOIs)

Timeframe: From Screening Day until Week 52 (EOS)

Number of Participants With Anti-drug Antibodies (ADAs) to ABP 654

Timeframe: Pre-dose on weeks 0 (day 1), 4, 12, 28, 32, 40, and on Week 52 (EOS)

Locations

Location
Status
Contact Us
Location
Revival Research
Doral, Florida, United States, 33122
Status
Completed
Location
Progressive Clinical Research [Texas]
San Antonio, Texas, United States, 78213
Status
Recruiting
Location
International Dermatology Research, Inc
Miami, Florida, United States, 33144
Status
Completed
Location
Center for Clinical Studies
Cypress, Texas, United States, 77433
Status
Recruiting
Location
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, United States, 66210
Status
Recruiting
Location
Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States, 85032
Status
Recruiting
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