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

A Multicenter, Randomized, Double-blinded Study Evaluating the Pharmacokinetics, Efficacy and Safety of Multiple Switches Between Ustekinumab and ABP 654 Compared With Continued Use of Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

The purpose of the study is to evaluate pharmacokinetic similarity, efficacy, safety and immunogenicity of multiple switches between ustekinumab and ABP 654 compared with continued use of ustekinumab in participants with moderate to severe plaque psoriasis.

Study Overview

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

Detailed Description

This is a multi-center study and will enroll approximately 480 participants.

After eligibility confirmation, all participants will be randomized in a 1:1 ratio into 2 treatment arms: continued use of ustekinumab or multiple switches between ustekinumab and ABP 654 at Week 28. The randomization will be stratified by prior biologic use for psoriasis (yes versus [vs] no) at baseline (Week 0), geographic region, and baseline (Week 0) body weight.

All participants will receive an initial 3 doses of ustekinumab on Day 1 (Week 0), Week 4 and Week 16. At Week 28, participants will be randomized to continue on ustekinumab or switching between ABP 654 and ustekinumab every 12 weeks.

At Week 28, efficacy assessments will be conducted including evaluation of Psoriasis and Area Severity Index (PASI). Participants who do not achieve PASI 50 response or better improvement at Week 28 will be considered as run-in failures and will not be randomized at Week 28; these participants will complete End of Study procedures at Week 28. The run-in period will occur from Day 1 until randomization at Week 28. Those unable to complete the Week 28 visit or did not have a PASI assessment completed at Week 28 will be discontinued from the study.

The total duration of study participation for each participant will be 68 weeks, with up to 4 weeks for screening and 64 weeks after the first investigational product administration.

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical Research
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc.
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Dr. Irina Turchin PC Inc.
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Center
    • Guelph, Ontario, Canada, N1L 0B7
      • Guelph Dermatology Research
    • London, Ontario, Canada, N6H 5L5
      • Dr Wei Jing Loo Medicine Professional Corporation
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research Inc.
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office
    • North York, Ontario, Canada, M2M 4J5
      • North York Research Inc. - Dermatology
    • Ottawa, Ontario, Canada, K2C 3N2
      • Dermatology Ottawa Research Centre
    • Toronto, Ontario, Canada, M4W 2N4
      • Research Toronto
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research Inc.
• Estonia
  • Tallinn, Estonia, 10117
    • Innomedica OÜ
  • Harjumaa
    • Tallinn, Harjumaa, Estonia, 10138
      • Confido Private Medical Clinic - General Practice/Medicine
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 50106
      • Clinical Research Center
    • Tartu, Tartumaa, Estonia, 50417
      • Tartu University Hospital
• Georgia
  • Tbilisi, Georgia, 0159
    • ,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC
  • T'bilisi
    • Tbilisi, T'bilisi, Georgia, 0112
      • Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
    • Tbilisi, T'bilisi, Georgia, 0112
      • LTD Israeli-Georgian Medical Research Clinic Helsicore
    • Tbilisi, T'bilisi, Georgia, 0159
      • ,,Tbilisi Cancer center"LTD
    • Tbilisi, T'bilisi, Georgia, 0160
      • LTD Aversi Clinic
• Germany
  • Berlin, Germany, 10117
    • Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
  • Berlin, Germany, 10783
    • Rothhaar Studien GmbH
  • Baden-Württemberg
    • Friedrichshafen, Baden-Württemberg, Germany, 88045
      • Derma-Study-Center-FN
  • Bayern
    • Augsburg, Bayern, Germany, 86179
      • Dermazentrum Augsburg
  • Brandenburg
    • Mahlow, Brandenburg, Germany, 15831
      • Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
  • Hessen
    • Frankfurt/Main, Hessen, Germany, 60590
      • Universitätsklinikum Frankfurt am Main - Klinik für Dermatol
  • Niedersachsen
    • Bad Bentheim, Niedersachsen, Germany, 48455
      • Fachklinik Bad Bentheim
  • Nordrhein-Westfalen
    • Witten, Nordrhein-Westfalen, Germany, 58453
      • Praxis Hoffmann
  • Sachsen
    • Dresden, Sachsen, Germany, 01069
      • Klinische Forschung Dresden GmbH
    • Dresden, Sachsen, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • UK-SH - Lübeck
• Hungary
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Központ Nagyerdei Campus
  • Jász-Nagykun-Szolnok
    • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
      • Brgyógyászati és Allergológiai Magánrendelés
  • Pest
    • Budapest, Pest, Hungary, 1036
      • Qualiclinic Kft
    • Budapest, Pest, Hungary, 1152
      • UNOMEDICALTRIALS Kft
• Latvia
  • 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
• Poland
  • Bialystok, Poland, 15-794
    • RENEW CLINIC Spolka Jawna
  • Bydgoszcz, Poland, 85-065
    • MICS Centrum Medyczne Bydgoszcz
  • Bydgoszcz, Poland, 85-796
    • Centrum Medyczne Pratia Bydgoszcz
  • Gdynia, Poland, 81-338
    • Centrum Medyczne Pratia Gdynia
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Krakow, Poland, 31-513
    • Centrum Medyczne Promed
  • Krakow, Poland, 31-559
    • Barbara Rewerska Diamond Clinic
  • Siedlce, Poland, 08-110
    • ETG Siedlce
  • Sochaczew, Poland, 96-500
    • RCMed Oddzial Sochaczew
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Warszawa, Poland, 00-892
    • RCMed Oddzia Warszawa
  • Warszawa, Poland, 02-625
    • Centrum Medyczne Evimed
  • Wroclaw, Poland, 51-318
    • Dermmedica Sp. Z O.O.
  • Maopolskie
    • Krakow, Maopolskie, Poland, 30-033
      • Centrum Medyczne All-med Badania Kliniczne
    • Krakow, Maopolskie, Poland, 30-363
      • Centrum Medyczne Plejady
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 00-874
      • MICS Centrum Medyczne Warszawa
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Beverly Hills, California, United States, 90212
      • Zenith Research Inc.
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, Inc.
    • Northridge, California, United States, 91324-4669
      • Quest Dermatology Research
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology, Inc
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Encore Research Group-Jacksonville Center for Clinical Resea
    • Lake Worth, Florida, United States, 33461
      • Altus Research, Inc.
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • Ormond Beach, Florida, United States, 32174
      • Leavitt Medical Associates of Florida d/b/a Ameriderm Research
    • Pembroke Pines, Florida, United States, 33028-1013
      • Riverchase Dermatology and Cosmetic Surgery
    • Tampa, Florida, United States, 33614
      • Olympian Clinical Research
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Hamilton Research, LLC
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research PC
  • Illinois
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • DS Research
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trial Services Inc.
  • Kansas
    • Topeka, Kansas, United States, 66614
      • Kansas Medical Clinic, PA
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Clinical Pharmacology Study Group
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists PC
  • 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
    • Verona, New Jersey, United States, 07044
      • The Dermatology Group, PC
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Texas
    • Dripping Springs, Texas, United States, 78620
      • Austin Institute for Clinical Research, Inc.
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research, Inc - Dermatology
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research [Texas]
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies, LTD., LLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has stable moderate to severe plaque psoriasis for at least 6 months
• Participant has a score of PASI ≥ 12, involvement of ≥ 10% body surface area and static Physician Global Assessment ≥ 3 at screening and at baseline
• Participant is a candidate for phototherapy or systemic therapy
• Participant has previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy
• Female participant should have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline
• Participant or legally acceptable representative is capable of giving signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) informed consent
• Participant has no known history of latent or active tuberculosis
• Participant with a positive purified protein derivative (PPD) test and a history of Bacillus Calmette-Guérin (BCG) vaccination is allowed with a negative Quantiferon/T-spot test

• Participant with a positive PPD test or participant with a positive or indeterminate Quantiferon/T-spot test is allowed if he/she has all the following:

  • No symptoms per tuberculosis worksheet provided by the sponsor, Amgen Inc.
  • Documented history of adequate prophylaxis initiation prior to receiving investigational product in accordance with local recommendations
  • No known exposure to a case of active tuberculosis after most recent prophylaxis
  • No evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product

Exclusion Criteria:

• Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis
• Participant has an active infection or history of infections
• Participant has uncontrolled, clinically significant systemic disease, such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension
• Participant has a mean QT internal or abnormal long QT syndrome corrected using Fridericia's formula (QTcF) of > 450 msec (for male participant) or > 470 msec (for female participant) at baseline that, in the opinion of the Investigator, is abnormal or clinically significant
• Participant has moderate to severe heart failure (New York Heart Associate class III/IV)
• Participant has known hypersensitivity to the investigational product or to any of the excipients
• Participant has laboratory abnormalities at screening
• Participant has had previous treatment with any agent specifically targeting interleukin (IL)-12 or IL-23 within 1 year prior to enrollment
• Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment
• Participant has received any investigational agents within the previous month or 5 half-lives (whichever is longer) prior to enrollment
• Participant has received non-biologic systemic psoriasis therapy within 4 weeks prior to enrollment
• Participant has received ultraviolet A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or ultraviolet B phototherapy within 2 weeks prior to enrollment
• Participant has received topical psoriasis treatment within 2 weeks prior to enrollment
• Participant has received other investigational procedures within 4 weeks prior to enrollment and during the course of the study
• Female participant is pregnant or breastfeeding or planning to become pregnant while participating in the study and for at least 5 months after the last dose of investigational product
• Sexually active participants and their partners who are of childbearing potential and not agreeing to use adequate protocol defined contraception methods while participating in the study and for 5 months after the last dose of investigational product

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continued-use Group (Ustekinumab); Participants will receive subcutaneous injection of ustekinumab up to Week 52.	Drug: Ustekinumab; Participants will receive subcutaneous (SC) injection of ustekinumab.; Other Names: Stelara®
Experimental: Switching Group (Ustekinumab - ABP 654); Participants will initially receive injection of ustekinumab up to Week 16. Thereafter, starting from Week 28, participants will switch between ABP 654 and ustekinumab every 12 weeks up to Week 52.	Drug: Ustekinumab; Participants will receive subcutaneous (SC) injection of ustekinumab.; Other Names: Stelara®; Drug: ABP 654; Participants will receive SC injection of ABP 654.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64	AUCtau from time 0 (week 52) over the dosing interval up to week 64 is presented. Pharmacokinetic (PK) parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.	Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64	Cmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.	Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Maximum Serum Concentration (Tmax) Between Week 52 and Week 64	Tmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.	Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52	Ctrough,ss at weeks 28, 40, and 52 are presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.	Blood samples were taken pre-dose week 28, week 40, and week 52
PASI Percent Improvement From Baseline at Week 64	The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI percent improvement is defined as 100 x (value at baseline - value at post-baseline visit) / value at baseline. A positive value indicates PASI improvement. Baseline data were derived based on observed data and at week 64 were derived based on multiple imputation (MI) data. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.	Baseline (day 1) and week 64
PASI 75 Response at Week 64	The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting or surpassing a pre-specified threshold for percent improvement in PASI score compared to the baseline PASI score. An improvement of at least 75% qualified a participant as being a PASI 75 responder. Missing PASI 75 responses at week 64 were imputed by non-responder imputation (NRI). Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.	Baseline (day 1) and week 64
PASI 100 Response at Week 64	The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting or surpassing a pre-specified threshold for percent improvement in PASI score compared to the baseline PASI score. An improvement of 100% qualified a participant as being a PASI 100 responder. Missing PASI 100 responses at week 64 were imputed by NRI. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.	Baseline (day 1) and week 64
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Post-randomization Period	TEAEs during the post-randomization period were defined as AEs that started on or after the first dose of investigational product post-randomization and prior to the end of study. The number of participants who experienced any TEAE, and who experienced a serious TEAE are presented. A serious TEAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or other medically important serious event.	Week 28 to week 64
Number of Participants With Events of Interest (EOI): Post-randomization Period	The treatment-emergent EOIs prespecified 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 (RPLS), serious depression including suicidality, and venous thromboembolism.	Week 28 to week 64
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period	The number of participants developing binding or neutralizing ADAs during the post-randomization period is defined as the number of participants in the safety analysis set who had a positive result post-randomization and had never tested positive (i.e., negative or no results) prior to the first dose of post-randomization investigational product and who have at least one ADA result post randomization. A transient antibody results was defined as a positive result during the post-randomization period with a negative result at the participant's last visit tested within the respective study period. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.	Baseline (pre-dose day 1), week 4, week 16, week 28, week 40, week 52 and week 64

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): March 24, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis; Biosimilar; Ustekinumab; Skin Diseases; Psoriasis area and severity index; Dermatologic Agents; Papulosquamous
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: 20200417; 2020-005205-42 (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