Clinical trial NCT04607980: A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Biosimilar
Psoriasis area and severity index
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 563
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 the efficacy, safety, and immunogenicity of ABP 654 compared with ustekinumab in participants with moderate to severe plaque psoriasis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PASI Percent Change From Baseline to Week 12
timeFrame: Baseline (Day 1 [Week 0]) and Week 12
Secondary outcomes:
measure: PASI Percent Change at Other Timepoints
timeFrame: 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])
measure: Percentage of Participants With PASI 75 Response Throughout the Study
timeFrame: 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)
measure: Percentage of Participants With PASI 100 Response Throughout the Study
timeFrame: 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)
measure: Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52
timeFrame: Week 12 and Week 52 (EOS)
measure: Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52
timeFrame: Baseline (Day 1 [Week 0]), Week 12 and Week 52 (EOS)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
measure: Number of Participants With Events of Interests (EOIs)
timeFrame: Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
measure: Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654
timeFrame: Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center PC
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology and Mohs Center
state: Arizona
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology and Laser Clinic - Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials
state: California
city: Doral
country: United States
facility: Revival Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Moore Clinical Research Inc.
state: Florida
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas, LLC
state: Kansas
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: Beverly
country: United States
facility: ALLCUTIS Research, LLC.
state: Massachusetts
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
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: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Exton
country: United States
facility: The Pennsylvania Centre for Dermatology, LLC
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Knoxville
country: United States
facility: The Skin Wellness Center PC
state: Tennessee
city: Cypress
country: United States
facility: Center for Clinical Studies
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research - Dermatology
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research [Texas]
state: Texas
city: Sugar Land
country: United States
facility: Acclaim Dermatology
state: Texas
city: Calgary
country: Canada
facility: Beacon Dermatology
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research Inc
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre Inc.
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research Inc.
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre - Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research Inc.
state: Ontario
city: Quebec city
country: Canada
facility: Centre de Recherche dermatolog
state: Quebec
city: Tallinn
country: Estonia
facility: Vahlberg & Pild OÜ
state: Harjumaa
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: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
state: Brandenburg
city: Bramsche
country: Germany
facility: Derma Zentrum Osnabrueck Nord
state: Niedersachsen
city: Bochum
country: Germany
facility: Hautzentrum im Jahrhunderthaus
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
facility: CentroDerm GmbH
state: Nordrhein-Westfalen
city: Szolnok
country: Hungary
facility: Brgyógyászati és Allergológiai Magánrendelés
state: Jász-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: UNOMEDICALTRIALS Kft
state: Pest
city: Riga
country: Latvia
facility: Health Centre 4 Ltd., Diagnostics Centre
state: Rga
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: Riga
country: Latvia
facility: Health and Aesthetics Ltd
city: Talsi
country: Latvia
facility: Smite Aija doctor practice in dermatology, venereology
city: Kaunas
country: Lithuania
facility: Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
state: Kauno Apskritis
city: Vilnius
country: Lithuania
facility: Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras
state: Vilniaus Apskritis
city: Krakow
country: Poland
facility: Centrum Medyczne ALL-MED
state: Maopolskie
city: Warszawa
country: Poland
facility: Medycyna Kliniczna
state: Mazowieckie
city: Warszawa
country: Poland
facility: ETG Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
state: Mazowieckie
city: Iwonicz Zdroj
country: Poland
facility: Zespol Naukowo-Leczniczy Iwolang sp. z.o.o.
state: Podkarpackie
city: Bialystok
country: Poland
facility: Specderm Poznanska Sp. j.
state: Podlaskie
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Sp. J.
state: Podlaskie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Krakow
country: Poland
facility: Barbara Rewerska Diamond Clinic
city: Lublin
country: Poland
facility: Centrum Zdrowia i Urody Maxxmed
city: Lublin
country: Poland
facility: ETG Lublin
city: Poznan
country: Poland
facility: Solumed
city: Torun
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Warszawa
country: Poland
facility: Klinika Ambroziak Dermatologia
city: Wroclaw
country: Poland
facility: DermMedica Sp. z o.o.
city: Wroclaw
country: Poland
facility: WroMedica I. Bielicka, A. Strzalkowska s.c.
city: Skierniewice
country: Poland
facility: ETG Skierniewice
state: Ódzkie
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: