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

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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: ABP 654; Drug: Ustekinumab

Detailed Description

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
• Enrollment (Actual): 563
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-Ho Hong Medical Inc.
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Kingsway Clinical Research
    • Hamilton, Ontario, Canada, L8N1Y2
      • Dermatrials Research Inc
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research Inc.
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre Inc.
    • Ottawa, Ontario, Canada, K1H 7X3
      • JRB Research Inc.
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKiN Centre for Dermatology
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre - Dermatology
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research Inc.
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 Medical Research Inc.
  • Quebec
    • Quebec city, Quebec, Canada, G1V 4X7
      • Centre de Recherche dermatolog
• Estonia
  • Harjumaa
    • Tallinn, Harjumaa, Estonia, 10138
      • Confido Private Medical Clinic - General Practice/Medicine
    • Tallinn, Harjumaa, Estonia, 10134
      • Vahlberg & Pild OU
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 50106
      • Clinical Research Center
    • Tartu, Tartumaa, Estonia, 50417
      • Tartu University Hospital
• Germany
  • Brandenburg
    • Mahlow, Brandenburg, Germany, 15831
      • Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
  • Niedersachsen
    • Bramsche, Niedersachsen, Germany, 49565
      • Derma Zentrum Osnabrueck Nord
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44793
      • Hautzentrum im Jahrhunderthaus
    • Wuppertal, Nordrhein-Westfalen, Germany, 42287
      • CentroDerm GmbH
• Hungary
  • Jász-Nagykun-Szolnok
    • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
      • Brgyógyászati és Allergológiai Magánrendelés
  • Pest
    • Budapest, Pest, Hungary, 1152
      • UNOMEDICALTRIALS Kft
• Latvia
  • Riga, Latvia, LV-1009
    • Health and Aesthetics Ltd
  • Talsi, Latvia, LV3201
    • Smite Aija doctor practice in dermatology, venereology
  • Rga
    • Riga, Rga, Latvia, LV1001
      • Riga 1st Hospital, Clinic of Dermatology and STD
    • Riga, Rga, Latvia, LV1003
      • J.Kisis LtD
    • Riga, Rga, Latvia, LV-1003
      • Health Centre 4 Ltd., Diagnostics Centre
• Lithuania
  • Kauno Apskritis
    • Kaunas, Kauno Apskritis, Lithuania, LT-50161
      • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
  • Vilniaus Apskritis
    • Vilnius, Vilniaus Apskritis, Lithuania, LT-08411
      • Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras
• Poland
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Katowice, Poland, 40-081
    • Centrum Medyczne Pratia Katowice
  • Krakow, Poland, 31-559
    • Barbara Rewerska Diamond Clinic
  • Lublin, Poland, 20-412
    • ETG Lublin
  • Lublin, Poland, 20-080
    • Centrum Zdrowia i Urody Maxxmed
  • Poznan, Poland, 60-529
    • SOLUMED
  • Torun, Poland, 87-100
    • Nasz Lekarz Osrodek Badan Klinicznych
  • Warszawa, Poland, 02-953
    • Klinika Ambroziak Dermatologia
  • Wroclaw, Poland, 51-318
    • dermMedica Sp. z o.o.
  • Wroclaw, Poland, 51-685
    • WroMedica I. Bielicka, A. Strzalkowska s.c.
  • Maopolskie
    • Krakow, Maopolskie, Poland, 30-033
      • Centrum Medyczne ALL-MED
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-793
      • ETG Warszawa
    • Warszawa, Mazowieckie, Poland, 00-874
      • Medycyna Kliniczna
    • Warszawa, Mazowieckie, Poland, 02-962
      • Royalderm Agnieszka Nawrocka
  • Podkarpackie
    • Iwonicz Zdroj, Podkarpackie, Poland, 38-440
      • Zespol Naukowo-Leczniczy Iwolang sp. z.o.o.
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-017
      • Specderm Poznanska Sp. j.
    • Bialystok, Podlaskie, Poland, 15-879
      • ClinicMed Daniluk, Nowak Sp. J.
  • Ódzkie
    • Skierniewice, Ódzkie, Poland, 96-100
      • ETG Skierniewice
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center PC
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and Mohs Center
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • San Diego, California, United States, 92123
      • University Clinical Trials, Inc.
    • San Luis Obispo, California, United States, 93405
      • San Luis Dermatology and Laser Clinic - Dermatology
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
    • Sherman Oaks, California, United States, 91403
      • Unison Clinical Trials
  • Florida
    • Doral, Florida, United States, 33122
      • Revival Research
    • Miami, Florida, United States, 33144
      • International Dermatology Research, INC
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Tampa, Florida, United States, 33609-2230
      • Moore Clinical Research Inc.
  • Illinois
    • Skokie, Illinois, United States, 60077
      • NorthShore University Healthsystem
    • Springfield, Illinois, United States, 62703-2403
      • Springfield Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46250-2041
      • Dawes Fretzin Clinical Research Group, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Epiphany Dermatology of Kansas, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • DelRicht Research
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • ALLCUTIS Research, LLC.
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices & Research, LLC.
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services, PLLC
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
  • Ohio
    • Bexley, Ohio, United States, 43209-2421
      • Bexley Dermatology Research
    • Mason, Ohio, United States, 45040
      • Dermatologists of Southwest Ohio
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • The Pennsylvania Centre for Dermatology, LLC
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center PC
  • Texas
    • Cypress, Texas, United States, 77433
      • Center for Clinical Studies
    • Dallas, Texas, United States, 75231
      • Modern Research Associates
    • Houston, Texas, United States, 77056
      • Austin Institute for Clinical Research - Dermatology
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research [Texas]
    • Sugar Land, Texas, United States, 77479-2645
      • Acclaim Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Drug: Ustekinumab; Participants will receive SC injection of ustekinumab.; Other Names: Stelara®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 1 [Week 0]) and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	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.	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.	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.	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.	Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): January 13, 2022
• Study Completion (Actual): June 3, 2022

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis; Biosimilar; Psoriasis area and severity index
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: 20190232; 2020-003184-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No