Clinical trial NCT04761627: A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Biosimilar
Psoriasis area and severity index
Ustekinumab
Skin Diseases
Dermatologic Agents
Papulosquamous
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64
timeFrame: 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
measure: Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64
timeFrame: 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 outcomes:
measure: Time of Maximum Serum Concentration (Tmax) Between Week 52 and Week 64
timeFrame: 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
measure: Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52
timeFrame: Blood samples were taken pre-dose week 28, week 40, and week 52
measure: PASI Percent Improvement From Baseline at Week 64
timeFrame: Baseline (day 1) and week 64
measure: PASI 75 Response at Week 64
timeFrame: Baseline (day 1) and week 64
measure: PASI 100 Response at Week 64
timeFrame: Baseline (day 1) and week 64
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs): Post-randomization Period
timeFrame: Week 28 to week 64
measure: Number of Participants With Events of Interest (EOI): Post-randomization Period
timeFrame: Week 28 to week 64
measure: Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period
timeFrame: Baseline (pre-dose day 1), week 4, week 16, week 28, week 40, week 52 and week 64
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Beverly Hills
country: United States
facility: Zenith Research Inc.
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc
state: California
city: Jacksonville
country: United States
facility: Encore Research Group-Jacksonville Center for Clinical Resea
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc.
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida d/b/a Ameriderm Research
state: Florida
city: Pembroke Pines
country: United States
facility: Riverchase Dermatology and Cosmetic Surgery
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research, LLC
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Clarksville
country: United States
facility: DS Research
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services Inc.
state: Iowa
city: Topeka
country: United States
facility: Kansas Medical Clinic, PA
state: Kansas
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, LLC.
state: New Hampshire
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Verona
country: United States
facility: The Dermatology Group, PC
state: New Jersey
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Dripping Springs
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc - Dermatology
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research [Texas]
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD., LLP
state: Texas
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc.
state: New Brunswick
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: London
country: Canada
facility: Dr Wei Jing Loo Medicine Professional Corporation
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Inc.
state: Ontario
city: Newmarket
country: Canada
facility: Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office
state: Ontario
city: North York
country: Canada
facility: North York Research Inc. - Dermatology
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
city: Tallinn
country: Estonia
facility: Confido Private Medical Clinic - General Practice/Medicine
state: Harjumaa
city: Tartu
country: Estonia
facility: Clinical Research Center
state: Tartumaa
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
city: Tallinn
country: Estonia
facility: Innomedica OÜ
city: Tbilisi
country: Georgia
facility: Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
state: T'bilisi
city: Tbilisi
country: Georgia
facility: LTD Israeli-Georgian Medical Research Clinic Helsicore
state: T'bilisi
city: Tbilisi
country: Georgia
facility: ,,Tbilisi Cancer center"LTD
state: T'bilisi
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
state: T'bilisi
city: Tbilisi
country: Georgia
facility: ,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center-FN
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Dermazentrum Augsburg
state: Bayern
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
state: Brandenburg
city: Frankfurt/Main
country: Germany
facility: Universitätsklinikum Frankfurt am Main - Klinik für Dermatol
state: Hessen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Niedersachsen
city: Witten
country: Germany
facility: Praxis Hoffmann
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
state: Sachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
state: Sachsen
city: Lübeck
country: Germany
facility: UK-SH - Lübeck
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ Nagyerdei Campus
state: Hajdú-Bihar
city: Szolnok
country: Hungary
facility: Brgyógyászati és Allergológiai Magánrendelés
state: Jász-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Qualiclinic Kft
state: Pest
city: Budapest
country: Hungary
facility: UNOMEDICALTRIALS Kft
state: Pest
city: Riga
country: Latvia
facility: Riga 1st hospital, Clinic of Dermatology and STD
state: Rga
city: Riga
country: Latvia
facility: J.Kisis LtD
state: Rga
city: Talsi
country: Latvia
facility: Smite Aija doctor practice in dermatology, venereology
city: Krakow
country: Poland
facility: Centrum Medyczne ALL-MED Badania Kliniczne
state: Maopolskie
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
state: Maopolskie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Bialystok
country: Poland
facility: RENEW CLINIC Spolka Jawna
city: Bydgoszcz
country: Poland
facility: MICS Centrum Medyczne Bydgoszcz
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Krakow
country: Poland
facility: Centrum Medyczne PROMED
city: Krakow
country: Poland
facility: Barbara Rewerska Diamond Clinic
city: Siedlce
country: Poland
facility: ETG Siedlce
city: Sochaczew
country: Poland
facility: RCMed Oddzial Sochaczew
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: RCMed Oddzia Warszawa
city: Warszawa
country: Poland
facility: Centrum Medyczne Evimed
city: Wroclaw
country: Poland
facility: DermMedica Sp. z o.o.
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: