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

NCT04607980 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 201902322020-003184-25
• Study Type: interventional
• Target: 563
• Locations: 8 countries
• Sites: 84

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.

Conditions

Plaque Psoriasis

Keywords

Psoriasis; Biosimilar; Psoriasis area and severity index

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• PASI Percent Change at Other Timepoints

  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

  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

  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

  Week 12 and Week 52 (EOS)

• Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52

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

Study Arms (2)

Treatment Group A (ABP 654)

EXPERIMENTAL

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

Treatment Group B (Ustekinumab - ABP 654)

EXPERIMENTAL

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; Drug: Ustekinumab

Interventions

ABP 654 DRUG

Participants will receive SC injection of ABP 654.

Treatment Group A (ABP 654); Treatment Group B (Ustekinumab - ABP 654)

Ustekinumab DRUG

Participants will receive SC injection of ustekinumab.

Also known as: Stelara®

Treatment Group B (Ustekinumab - ABP 654)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (84)

Total Skin and Beauty Dermatology Center PC

Birmingham, Alabama, 35205, United States

Location

Alliance Dermatology and Mohs Center

Phoenix, Arizona, 85032, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

University Clinical Trials, Inc.

San Diego, California, 92123, United States

Location

San Luis Dermatology and Laser Clinic - Dermatology

San Luis Obispo, California, 93405, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

Revival Research

Doral, Florida, 33122, United States

Location

International Dermatology Research, Inc

Miami, Florida, 33144, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Moore Clinical Research Inc.

Tampa, Florida, 33609-2230, United States

Location

NorthShore University HealthSystem

Skokie, Illinois, 60077, United States

Location

Springfield Clinic

Springfield, Illinois, 62703-2403, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250-2041, United States

Location

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, 66210, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

ALLCUTIS Research, LLC.

Beverly, Massachusetts, 01915, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

ActivMed Practices & Research, LLC.

Portsmouth, New Hampshire, 03801, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

Bexley Dermatology Research

Bexley, Ohio, 43209-2421, United States

Location

Dermatologists of Southwest Ohio

Mason, Ohio, 45040, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, 19341, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

The Skin Wellness Center PC

Knoxville, Tennessee, 37922, United States

Location

Center for Clinical Studies

Cypress, Texas, 77433, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Austin Institute for Clinical Research - Dermatology

Houston, Texas, 77056, United States

Location

Progressive Clinical Research [Texas]

San Antonio, Texas, 78213, United States

Location

Acclaim Dermatology

Sugar Land, Texas, 77479-2645, United States

Location

Beacon Dermatology

Calgary, Alberta, T3E 0B2, Canada

Location

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

CCA Medical Research

Ajax, Ontario, L1S 7K8, Canada

Location

Kingsway Clinical Research

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Dermatrials Research Inc

Hamilton, Ontario, L8N1Y2, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research Inc.

Mississauga, Ontario, L4Y 4C5, Canada

Location

North Bay Dermatology Centre Inc.

North Bay, Ontario, P1B 3Z7, Canada

Location

JRB Research Inc.

Ottawa, Ontario, K1H 7X3, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Toronto Research Centre - Dermatology

Toronto, Ontario, M3H 5Y8, Canada

Location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research Inc.

Windsor, Ontario, N8W 1E6, Canada

Location

Centre de Recherche dermatolog

Québec, Quebec, G1V 4X7, Canada

Location

Vahlberg & Pild OÜ

Tallinn, Harju, 10134, Estonia

Location

Confido Private Medical Clinic - General Practice/Medicine

Tallinn, Harju, 10138, Estonia

Location

Clinical Research Center

Tartu, Tartu, 50106, Estonia

Location

Tartu University Hospital

Tartu, Tartu, 50417, Estonia

Location

Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling

Mahlow, Brandenburg, 15831, Germany

Location

Derma Zentrum Osnabrueck Nord

Bramsche, Lower Saxony, 49565, Germany

Location

Hautzentrum im Jahrhunderthaus

Bochum, North Rhine-Westphalia, 44793, Germany

Location

CentroDerm GmbH

Wuppertal, North Rhine-Westphalia, 42287, Germany

Location

Brgyógyászati és Allergológiai Magánrendelés

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

UNOMEDICALTRIALS Kft

Budapest, Pest County, 1152, Hungary

Location

Health Centre 4 Ltd., Diagnostics Centre

Riga, Rga, LV-1003, Latvia

Location

Riga 1st hospital, Clinic of Dermatology and STD

Riga, Rga, LV1001, Latvia

Location

J.Kisis LtD

Riga, Rga, LV1003, Latvia

Location

Health and Aesthetics Ltd

Riga, LV-1009, Latvia

Location

Smite Aija doctor practice in dermatology, venereology

Talsi, LV3201, Latvia

Location

Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik

Kaunas, Kaunas County, LT-50161, Lithuania

Location

Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras

Vilnius, Vilnius County, LT-08411, Lithuania

Location

Centrum Medyczne ALL-MED

Krakow, Maopolskie, 30-033, Poland

Location

Medycyna Kliniczna

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

ETG Warszawa

Warsaw, Masovian Voivodeship, 02-793, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

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

Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440, Poland

Location

Specderm Poznanska Sp. j.

Bialystok, Podlaskie Voivodeship, 15-017, Poland

Location

ClinicMed Daniluk, Nowak Sp. J.

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40-081, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Barbara Rewerska Diamond Clinic

Krakow, 31-559, Poland

Location

Centrum Zdrowia i Urody Maxxmed

Lublin, 20-080, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Solumed

Poznan, 60-529, Poland

Location

Nasz Lekarz Osrodek Badan Klinicznych

Torun, 87-100, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, 02-953, Poland

Location

DermMedica Sp. z o.o.

Wroclaw, 51-318, Poland

Location

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

Wroclaw, 51-685, Poland

Location

ETG Skierniewice

Skierniewice, Ódzkie, 96-100, Poland

Location

Related Publications (1)

• 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.

  PMID: 39442018 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to non-convergence of the generalized linear model used for pre-specified analyses, ad hoc analyses were conducted for efficacy endpoints of PASI 75 response, PASI 100 response, and sPGA response.

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

8665726436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigators, study personnel with the exception of the clinical research organization's unblinded biostatistician and unblinded programmers; and the data monitoring committee, and the study participants will remain blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 29, 2020
• Study Start: November 11, 2020
• Primary Completion: January 13, 2022
• Study Completion: June 3, 2022
• Last Updated: December 12, 2024
• Results First Posted: December 15, 2023

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

DE (4); LI (2); ES (4); LA (5); PL (18); US (34); HU (2); CA (15)