AzTrials
AzTrials

Plaque PsoriasisPhase 3NCT04607980

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

A Phase 3 study testing ABP 654 and Ustekinumab in people with Plaque Psoriasis, run by Amgen at 84 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
ABP 654 and Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
563 participants
Where
84 sitesin 8 countries
Study dates
11 Nov 2020to 3 Jun 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

84 sites in 8 countries.

84 sites in 8 countries

United States34 sites

  • DelRicht Research

    Baton Rouge, Louisiana, 70809

  • ALLCUTIS Research, LLC.

    Beverly, Massachusetts, 01915

  • Bexley Dermatology Research

    Bexley, Ohio, 43209-2421

  • Total Skin and Beauty Dermatology Center PC

    Birmingham, Alabama, 35205

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135

  • Center for Clinical Studies

    Cypress, Texas, 77433

  • Modern Research Associates

    Dallas, Texas, 75231

  • Revival Research

    Doral, Florida, 33122

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • The Pennsylvania Centre for Dermatology, LLC

    Exton, Pennsylvania, 19341

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Dermatology Consulting Services, PLLC

    High Point, North Carolina, 27262

  • Austin Institute for Clinical Research - Dermatology

    Houston, Texas, 77056

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250-2041

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • The Skin Wellness Center PC

    Knoxville, Tennessee, 37922

  • Dermatologists of Southwest Ohio

    Mason, Ohio, 45040

  • International Dermatology Research, Inc

    Miami, Florida, 33144

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Epiphany Dermatology of Kansas, LLC

    Overland Park, Kansas, 66210

  • Alliance Dermatology and Mohs Center

    Phoenix, Arizona, 85032

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Oregon Medical Research Center

    Portland, Oregon, 97223

  • ActivMed Practices & Research, LLC.

    Portsmouth, New Hampshire, 03801

  • Progressive Clinical Research [Texas]

    San Antonio, Texas, 78213

  • University Clinical Trials, Inc.

    San Diego, California, 92123

  • San Luis Dermatology and Laser Clinic - Dermatology

    San Luis Obispo, California, 93405

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Unison Clinical Trials

    Sherman Oaks, California, 91403

  • NorthShore University HealthSystem

    Skokie, Illinois, 60077

  • Springfield Clinic

    Springfield, Illinois, 62703-2403

  • Acclaim Dermatology

    Sugar Land, Texas, 77479-2645

  • Moore Clinical Research Inc.

    Tampa, Florida, 33609-2230

  • Wilmington Dermatology Center

    Wilmington, North Carolina, 28405

Other trials in United States

Poland18 sites

  • Specderm Poznanska Sp. j.

    Bialystok, Podlaskie Voivodeship, 15-017

  • ClinicMed Daniluk, Nowak Sp. J.

    Bialystok, Podlaskie Voivodeship, 15-879

  • Zespol Naukowo-Leczniczy Iwolang sp. z.o.o.

    Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

  • Centrum Medyczne ALL-MED

    Krakow, Maopolskie, 30-033

  • Barbara Rewerska Diamond Clinic

    Krakow, 31-559

  • Centrum Zdrowia i Urody Maxxmed

    Lublin, 20-080

  • ETG Lublin

    Lublin, 20-412

  • Solumed

    Poznan, 60-529

  • ETG Skierniewice

    Skierniewice, Ódzkie, 96-100

  • Nasz Lekarz Osrodek Badan Klinicznych

    Torun, 87-100

  • Medycyna Kliniczna

    Warsaw, Masovian Voivodeship, 00-874

  • ETG Warszawa

    Warsaw, Masovian Voivodeship, 02-793

  • Royalderm Agnieszka Nawrocka

    Warsaw, Masovian Voivodeship, 02-962

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953

  • DermMedica Sp. z o.o.

    Wroclaw, 51-318

  • WroMedica I. Bielicka, A. Strzalkowska s.c.

    Wroclaw, 51-685

Other trials in Poland

Canada15 sites

  • CCA Medical Research

    Ajax, Ontario, L1S 7K8

  • Beacon Dermatology

    Calgary, Alberta, T3E 0B2

  • Kingsway Clinical Research

    Etobicoke, Ontario, M8X 1Y9

  • Dermatrials Research Inc

    Hamilton, Ontario, L8N1Y2

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3

  • DermEdge Research Inc.

    Mississauga, Ontario, L4Y 4C5

  • North Bay Dermatology Centre Inc.

    North Bay, Ontario, P1B 3Z7

  • JRB Research Inc.

    Ottawa, Ontario, K1H 7X3

  • Skin Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche dermatolog

    Québec, Quebec, G1V 4X7

  • The Centre for Dermatology

    Richmond Hill, Ontario, L4B 1A5

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7

  • Toronto Research Centre - Dermatology

    Toronto, Ontario, M3H 5Y8

  • K. Papp Clinical Research Inc.

    Waterloo, Ontario, N2J 1C4

  • XLR8 Medical Research Inc.

    Windsor, Ontario, N8W 1E6

Other trials in Canada

Latvia5 sites

  • Health Centre 4 Ltd., Diagnostics Centre

    Riga, Rga, LV-1003

  • Riga 1st hospital, Clinic of Dermatology and STD

    Riga, Rga, LV1001

  • J.Kisis LtD

    Riga, Rga, LV1003

  • Health and Aesthetics Ltd

    Riga, LV-1009

  • Smite Aija doctor practice in dermatology, venereology

    Talsi, LV3201

Other trials in Latvia

Estonia4 sites

  • Vahlberg & Pild OÜ

    Tallinn, Harju, 10134

  • Confido Private Medical Clinic - General Practice/Medicine

    Tallinn, Harju, 10138

  • Clinical Research Center

    Tartu, Tartu, 50106

  • Tartu University Hospital

    Tartu, Tartu, 50417

Other trials in Estonia

Germany4 sites

  • Hautzentrum im Jahrhunderthaus

    Bochum, North Rhine-Westphalia, 44793

  • Derma Zentrum Osnabrueck Nord

    Bramsche, Lower Saxony, 49565

  • Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling

    Mahlow, Brandenburg, 15831

  • CentroDerm GmbH

    Wuppertal, North Rhine-Westphalia, 42287

Other trials in Germany

Hungary2 sites

  • UNOMEDICALTRIALS Kft

    Budapest, Pest County, 1152

  • Brgyógyászati és Allergológiai Magánrendelés

    Szolnok, Jász-Nagykun-Szolnok, 5000

Other trials in Hungary

Lithuania2 sites

  • Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik

    Kaunas, Kaunas County, LT-50161

  • Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras

    Vilnius, Vilnius County, LT-08411

Other trials in Lithuania

About this study

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

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.

Read the 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.
Being tested
ABP 654, Ustekinumab
Keywords
Psoriasis, Biosimilar, Psoriasis area and severity index
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABP 654Drug

    Participants will receive SC injection of ABP 654.

  • UstekinumabDrug

    Also called Stelara®

    Participants will receive SC injection of ustekinumab.

Study groups in NCT04607980
Study groupRoleWhat they receive
Treatment Group A (ABP 654)ExperimentalParticipants 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.
Receives: Drug: ABP 654
Treatment Group B (Ustekinumab - ABP 654)ExperimentalParticipants 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.
Receives: Drug: ABP 654; Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Day 1 [Week 0]) and Week 12

Secondary outcomes (8)

  1. 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.

    Measured: 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])

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: Week 12 and Week 52 (EOS)

  5. 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.

    Measured: Baseline (Day 1 [Week 0]), Week 12 and Week 52 (EOS)

  6. 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.

    Measured: Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)

  7. 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.

    Measured: Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)

  8. 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.

    Measured: Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start11 Nov 2020
  3. Primary completion13 Jan 2022
  4. Study completion3 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
563 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607980
Sponsor's protocol ID
20190232
Other IDs
2020-003184-25
Status last verified
Dec 2024
First submitted
23 Oct 2020
Last updated
12 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

  • Blauvelt A, Papp K, Trivedi M, Barragan C, Chow V, Mytych DT, Yamauchi P, Crowley J, Franklin J. Efficacy and safety of the ustekinumab biosimilar ABP 654 in patients with moderate-to-severe plaque psoriasis: a randomized double-blinded active-controlled comparative clinical study over 52 weeks. Br J Dermatol. 2025 Apr 28;192(5):826-836. doi: 10.1093/bjd/ljae402.

    PubMed 39442018

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABP 654 and Ustekinumab in people with Plaque Psoriasis, run by Amgen at 84 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Poland, Canada, Latvia, Estonia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PASI Percent Change From Baseline to Week 12 (time frame: Baseline (Day 1 [Week 0]) and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607980, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in