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.
This is a multicenter study and will enroll approximately 542 participants. The total duration of study participation for each participant will be 56 weeks, with up to 4 weeks for screening, and for 52 weeks after the first administration of either ABP 654 or ustekinumab. After confirmation of eligibility, all participants will be randomized in a 1:1 ratio into 2 treatment groups (Group A will receive ABP 654, and Group B will receive ustekinumab) stratified by prior biologic use for psoriasis (yes versus \[vs\] no), geographic region, and baseline body weight (BW). Based on the psoriasis area and severity index (PASI) score (to determine better improvement or partial improvement) at week 28, the participants in the study will proceed as follows: 1. Participants who do not achieve PASI 50 response or better improvement at Week 28 will be considered to have completed the study and will complete end of study procedures (ie, week 52 procedures), and those unable to complete week 28 visit, or did not have a PASI assessment completed, will be discontinued from the study. 2. Participants who achieve PASI 75 response or better improvement will continue on the study and will be re-randomized in a blinded fashion such that participants initially randomized to Group A (ABP 654) will continue to receive ABP 654 and those in Group B (ustekinumab) will re-randomized, to either continue on ustekinumab (Treatment Group B1) or switch to ABP 654 (Treatment Group B2). 3. Participants with PASI 50 response or better but less than PASI 75 response and on the Investigator's decision, participants will continue on the originally assigned treatment with dose intensification and will not be re-randomized. However, participants that do not dose intensify will be re-randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
563
Participants will receive SC injection of ABP 654.
Participants will receive SC injection of ustekinumab.
PASI Percent Change From Baseline to Week 12
The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
Time frame: Baseline (Day 1 [Week 0]) and Week 12
PASI Percent Change at Other Timepoints
The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
Time frame: Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (End of Study [EOS])
Percentage of Participants With PASI 75 Response Throughout the Study
Reduction in disease was measured by PASI score. The PASI 75 response is a 75% or greater improvement (reduction in disease \[PASI 75\]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
Time frame: Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (EOS)
Percentage of Participants With PASI 100 Response Throughout the Study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, United States
Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States
First OC Dermatology
Fountain Valley, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
San Luis Dermatology and Laser Clinic - Dermatology
San Luis Obispo, California, United States
Clinical Science Institute
Santa Monica, California, United States
Unison Clinical Trials
Sherman Oaks, California, United States
Revival Research
Doral, Florida, United States
International Dermatology Research, Inc
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
...and 74 more locations
Reduction in disease was measured by PASI score. The PASI 100 response is a 100% improvement (reduction in disease \[PASI 100\]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
Time frame: Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (EOS)
Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response was defined as a sPGA value of clear (score 0) or almost clear (score 1). Higher scores represent worse symptom severity.
Time frame: Week 12 and Week 52 (EOS)
Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52
The percentage of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represents roughly 1% of the body's surface.
Time frame: Baseline (Day 1 [Week 0]), Week 12 and Week 52 (EOS)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs were summarized by actual treatment received. For each category, participants were included only once, even if they experienced multiple events in that category.
Time frame: Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
Number of Participants With Events of Interests (EOIs)
The EOIs pre-specified for this study included serious systemic hypersensitivity reactions, facial palsy, pustular psoriasis, erythrodermic psoriasis, serious infections (including mycobacterial and salmonella infections), malignancy, cardiovascular events, reversible posterior leukoencephalopathy syndrome, serious depression including suicidality, and venous thromboembolism.
Time frame: Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654
A participant was considered to have developed ADAs if they: * had a positive post-baseline binding or neutralizing antibody result with a negative or no result at Baseline or * had a positive post-baseline binding or neutralizing antibody result with a negative or no result prior to the first dose in the post Week 28 study period.
Time frame: Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)