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

NCT ID: NCT04607980

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 563 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-11
• Study Completion Date: 2022-06-03

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.

Conditions

Plaque Psoriasis

Keywords

Psoriasis; Biosimilar; Psoriasis area and severity index

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Group A (ABP 654)

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.

Group Type: EXPERIMENTAL

ABP 654

Intervention Type: DRUG

Participants will receive SC injection of ABP 654.

Treatment Group B (Ustekinumab - ABP 654)

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.

Group Type: EXPERIMENTAL

ABP 654

Intervention Type: DRUG

Participants will receive SC injection of ABP 654.

Ustekinumab

Intervention Type: DRUG

Participants will receive SC injection of ustekinumab.

Interventions

ABP 654

Participants will receive SC injection of ABP 654.

Intervention Type: DRUG

Ustekinumab

Participants will receive SC injection of ustekinumab.

Intervention Type: DRUG

Other Intervention Names

Stelara®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Total Skin and Beauty Dermatology Center PC

Birmingham, Alabama, United States

Alliance Dermatology and Mohs Center

Phoenix, Arizona, United States

First OC Dermatology

Fountain Valley, California, United States

University Clinical Trials, Inc.

San Diego, California, United States

San Luis Dermatology and Laser Clinic - Dermatology

San Luis Obispo, California, United States

Clinical Science Institute

Santa Monica, California, United States

Unison Clinical Trials

Sherman Oaks, California, United States

Revival Research

Doral, Florida, United States

International Dermatology Research, Inc

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Moore Clinical Research Inc.

Tampa, Florida, United States

NorthShore University HealthSystem

Skokie, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, United States

DelRicht Research

Baton Rouge, Louisiana, United States

ALLCUTIS Research, LLC.

Beverly, Massachusetts, United States

Metro Boston Clinical Partners

Brighton, Massachusetts, United States

ActivMed Practices & Research, LLC.

Portsmouth, New Hampshire, United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States

Wilmington Dermatology Center

Wilmington, North Carolina, United States

Bexley Dermatology Research

Bexley, Ohio, United States

Dermatologists of Southwest Ohio

Mason, Ohio, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Oregon Medical Research Center

Portland, Oregon, United States

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

The Skin Wellness Center PC

Knoxville, Tennessee, United States

Center for Clinical Studies

Cypress, Texas, United States

Modern Research Associates

Dallas, Texas, United States

Austin Institute for Clinical Research - Dermatology

Houston, Texas, United States

Progressive Clinical Research [Texas]

San Antonio, Texas, United States

Acclaim Dermatology

Sugar Land, Texas, United States

Beacon Dermatology

Calgary, Alberta, Canada

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, Canada

CCA Medical Research

Ajax, Ontario, Canada

Kingsway Clinical Research

Etobicoke, Ontario, Canada

Dermatrials Research Inc

Hamilton, Ontario, Canada

Lynderm Research Inc

Markham, Ontario, Canada

DermEdge Research Inc.

Mississauga, Ontario, Canada

North Bay Dermatology Centre Inc.

North Bay, Ontario, Canada

JRB Research Inc.

Ottawa, Ontario, Canada

Skin Centre for Dermatology

Peterborough, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

Toronto Research Centre - Dermatology

Toronto, Ontario, Canada

K. Papp Clinical Research Inc.

Waterloo, Ontario, Canada

XLR8 Medical Research Inc.

Windsor, Ontario, Canada

Centre de Recherche dermatolog

Québec, Quebec, Canada

Vahlberg & Pild OÜ

Tallinn, Harju, Estonia

Confido Private Medical Clinic - General Practice/Medicine

Tallinn, Harju, Estonia

Clinical Research Center

Tartu, Tartu, Estonia

Tartu University Hospital

Tartu, Tartu, Estonia

Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling

Mahlow, Brandenburg, Germany

Derma Zentrum Osnabrueck Nord

Bramsche, Lower Saxony, Germany

Hautzentrum im Jahrhunderthaus

Bochum, North Rhine-Westphalia, Germany

CentroDerm GmbH

Wuppertal, North Rhine-Westphalia, Germany

Brgyógyászati és Allergológiai Magánrendelés

Szolnok, Jász-Nagykun-Szolnok, Hungary

UNOMEDICALTRIALS Kft

Budapest, Pest County, Hungary

Health Centre 4 Ltd., Diagnostics Centre

Riga, Rga, Latvia

Riga 1st hospital, Clinic of Dermatology and STD

Riga, Rga, Latvia

J.Kisis LtD

Riga, Rga, Latvia

Health and Aesthetics Ltd

Riga, , Latvia

Smite Aija doctor practice in dermatology, venereology

Talsi, , Latvia

Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik

Kaunas, Kaunas County, Lithuania

Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras

Vilnius, Vilnius County, Lithuania

Centrum Medyczne ALL-MED

Krakow, Maopolskie, Poland

Medycyna Kliniczna

Warsaw, Masovian Voivodeship, Poland

ETG Warszawa

Warsaw, Masovian Voivodeship, Poland

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, Poland

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

Iwonicz-Zdrój, Podkarpackie Voivodeship, Poland

Specderm Poznanska Sp. j.

Bialystok, Podlaskie Voivodeship, Poland

ClinicMed Daniluk, Nowak Sp. J.

Bialystok, Podlaskie Voivodeship, Poland

Centrum Medyczne Pratia Katowice

Katowice, , Poland

Centrum Medyczne Angelius Provita

Katowice, , Poland

Barbara Rewerska Diamond Clinic

Krakow, , Poland

Centrum Zdrowia i Urody Maxxmed

Lublin, , Poland

ETG Lublin

Lublin, , Poland

Solumed

Poznan, , Poland

Nasz Lekarz Osrodek Badan Klinicznych

Torun, , Poland

Klinika Ambroziak Dermatologia

Warsaw, , Poland

DermMedica Sp. z o.o.

Wroclaw, , Poland

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

Wroclaw, , Poland

ETG Skierniewice

Skierniewice, Ódzkie, Poland

Countries

United States; Canada; Estonia; Germany; Hungary; Latvia; Lithuania; Poland

References

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.

Reference Type: DERIVED

PMID: 39442018 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2020-003184-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20190232

Identifier Type: -

Identifier Source: org_study_id