A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT04607980|
Recruitment Status : Completed
First Posted : October 29, 2020
Last Update Posted : November 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: ABP 654 Drug: Ustekinumab||Phase 3|
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:
- 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.
- 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).
- 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 (Clinical Trial)|
|Actual Enrollment :||563 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The Investigators, study personnel with the exception of the clinical research organization's unblinded biostatistician and unblinded programmers; and the data monitoring committee, and the study participants will remain blinded to treatment allocation.|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of ABP 654 Compared With Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis|
|Actual Study Start Date :||November 11, 2020|
|Actual Primary Completion Date :||January 13, 2022|
|Actual Study Completion Date :||June 3, 2022|
Experimental: Treatment Group A (ABP 654)
Participants will receive subcutaneous (SC) injection of ABP 654, 45 mg (baseline BW less than equal to [<=] 100 kg) or 90 mg (baseline BW greater than [>] 100 kg) at weeks 0, 4, and 16. Further from week 28 participants will receive ABP 654 (same dose) every 12 weeks (Q12W) at weeks 28 and 40 or may receive dose intensification Q8W at weeks 28, 36, and 44, depending on PASI score.
Drug: ABP 654
Participants will receive SC injection of ABP 654.
Experimental: Treatment Group B (Ustekinumab - ABP 654)
Participants will receive SC injection of ustekinumab,45 mg (baseline BW <= 100 kg) or 90 mg (baseline BW > 100 kg) at weeks 0, 4, and 16. At week 28, participants will be re-randomized to continue on ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) on weeks 28 and 40. Depending on PASI score, some participants may not be re-randomized and may receive dose intensification with ustekinumab Q8W at weeks 28, 36, and 44.
Drug: ABP 654
Participants will receive SC injection of ABP 654.
Participants will receive SC injection of ustekinumab.
Other Name: Stelara®
- Percent Improvement in PASI From Baseline to Week 12 [ Time Frame: Baseline (Day 1 [Week 0]) until 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. The higher score represents the worse symptom severity.
- Percent Improvement in PASI at Other Timepoints [ Time Frame: Baseline (Day 1 [Week 0]), weeks 4, 12, 16, 28, 36, 40, 44 and Week 52 (end of study [EOS]) ]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. The higher score represents the worse symptom severity.
- Percentage of Participants with PASI 75 Response Throughout the Study [ Time Frame: Baseline (Day 1 [Week 0]), weeks 4, 12, 16, 28, 36, 40, 44 and Week 52 (EOS) ]Reduction in disease as 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. The higher score represents the worse symptom severity.
- Percentage of Participants with PASI 100 Response Throughout the Study [ Time Frame: Baseline (Day 1 [Week 0]), weeks 4, 12, 16, 28, 36, 40, 44 and Week 52 (EOS) ]Reduction in disease as 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. The higher score represents the worse symptom severity.
- Percentage of Participants With Static Physician's Global Assessment (sPGA) Responses (0/1) at Week 12 and Week 52 [ Time Frame: 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 is defined as a sPGA value of clear (score 0) or almost clear (score 1). The higher score represents the worse symptom severity.
- Change From Baseline in Percentage of Body Surface Area (BSA) Affected with Psoriasis at Week 12 and Week 52 [ Time Frame: Week 12 and Week 52 ]The percent of BSA affected (%BSA) is estimated by assuming that the participant's palm, excluding the fingers and thumb, represents roughly 1% of the body's surface.
- Number of participants With Treatment Emergent Adverse Events and Serious Adverse Events [ Time Frame: From Screening Day until Week 52 (EOS) ]Assessment of the safety of ABP 654 compared with ustekinumab.
- Events of Interests (EOIs) [ Time Frame: From Screening Day until Week 52 (EOS) ]Assessment of the safety of ABP 654 compared with ustekinumab.
- Number of Participants With Anti-drug Antibodies (ADAs) to ABP 654 [ Time Frame: Pre-dose on weeks 0 (day 1), 4, 12, 28, 32, 40, and on Week 52 (EOS) ]The detection and characterization of antibodies to ABP 654 will be performed.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Participants are eligible to be included in the study only if all of the following criteria apply:
- Stable moderate to severe plaque psoriasis for at least 6 months
- Baseline score of PASI >= 12, involvement of >= 10% BSA, and sPGA >= 3 at screening and at baseline
- Candidate for phototherapy or systemic therapy
- Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
- Female participants should have negative serum pregnancy test during screening and a negative urine pregnancy test at baseline
- No known history of latent or active tuberculosis (TB), and has a negative test for TB during screening (with negative purified protein derivative (PPD), and Negative Quantiferon®/T-spot test)
- Participants with a positive purified protein derivative and a history of Bacillus Calmette-Guérin (BCG) vaccination are allowed with a negative Quantiferon®/T-spot®
Participants with a positive PPD test (without history of BCG vaccination) or participants with a positive or indeterminate Quantiferon®/T-spot test are allowed if they have all of the following:
- No symptoms per TB worksheet provided by the sponsor
- Documented history of adequate prophylaxis initiation prior to receiving investigational product (IP) in accordance with local recommendations
- No known exposure to a case of active TB after most recent prophylaxis
- No evidence of active TB on chest radiograph within 3 months prior to the first dose of IP
Participants are excluded from the study if any of the following criteria apply:
- Skin disease related conditions such as, Erythrodermic psoriasis (PsO), pustular PsO, guttate PsO, medication induced PsO, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of IP on PsO
- Participant has an active infection, recurrent or chronic infections, serious infection or history of infections
- Known history of human immunodeficiency virus
- Hepatitis B surface antigen or hepatitis C virus antibody positivity at screening
- Uncontrolled, clinically significant systemic disease such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension
- Moderate to severe heart failure (New York Heart Associate class III/IV)
- Known hypersensitivity to the IP or to any of the excipients
- Any abnormal laboratory parameters at screening, as defined in protocol
- Previous treatment with any agent specifically targeting interleukin (IL)-12 or IL-23
- Received biologic treatment for psoriasis within the previous month or 5 drug half-lives prior to randomization
- Received non-biologic systemic psoriasis therapy within 4 weeks prior to randomization
- Received Ultra-violet A (UVA) phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to randomization, or ultra-violet B (UVB) phototherapy within 2 weeks prior to randomization
- Received topical psoriasis treatment within 2 weeks prior to randomization (exception: upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, face, and intertriginous areas; bland emollients)
- Received live viral or live bacterial vaccination within 2 weeks prior to randomization
- Received BCG vaccination within 1 year prior to randomization
- Other investigational procedures within 4 weeks prior to randomization and during the study
- Participants not agreeing to follow protocol defined contraceptives procedures
- Participants likely not to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04607980
|Other Study ID Numbers:||
2020-003184-25 ( EudraCT Number )
|First Posted:||October 29, 2020 Key Record Dates|
|Last Update Posted:||November 22, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.|
|Access Criteria:||Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Psoriasis area and severity index
Skin Diseases, Papulosquamous