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

NCT04761627 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 202004172020-005205-42
• Study Type: interventional
• Target: 494
• Locations: 8 countries
• Sites: 88

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.

Conditions

Psoriasis

Keywords

Psoriasis; Biosimilar; Psoriasis area and severity index; Ustekinumab; Skin Diseases; Dermatologic Agents; Papulosquamous

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64

  AUCtau from time 0 (week 52) over the dosing interval up to week 64 is presented. Pharmacokinetic (PK) parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.

  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

• Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64

  Cmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.

  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 (8)

• Time of Maximum Serum Concentration (Tmax) Between Week 52 and Week 64

  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

• Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52

  Blood samples were taken pre-dose week 28, week 40, and week 52

• PASI Percent Improvement From Baseline at Week 64

  Baseline (day 1) and week 64

• PASI 75 Response at Week 64

  Baseline (day 1) and week 64

• PASI 100 Response at Week 64

  Baseline (day 1) and week 64

Study Arms (2)

Continued-use Group (Ustekinumab)

ACTIVE COMPARATOR

Participants will receive subcutaneous injection of ustekinumab up to Week 52.

Drug: Ustekinumab

Switching Group (Ustekinumab - ABP 654)

EXPERIMENTAL

Participants will initially receive injection of ustekinumab up to Week 16. Thereafter, starting from Week 28, participants will switch between ABP 654 and ustekinumab every 12 weeks up to Week 52.

Drug: Ustekinumab; Drug: ABP 654

Interventions

Ustekinumab DRUG

Participants will receive subcutaneous (SC) injection of ustekinumab.

Also known as: Stelara®

Continued-use Group (Ustekinumab); Switching Group (Ustekinumab - ABP 654)

ABP 654 DRUG

Participants will receive SC injection of ABP 654.

Switching Group (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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (88)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Zenith Research Inc.

Beverly Hills, California, 90212, United States

Location

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Quest Dermatology Research

Northridge, California, 91324-4669, United States

Location

Southern California Dermatology, Inc

Santa Ana, California, 92701, United States

Location

Encore Research Group-Jacksonville Center for Clinical Resea

Jacksonville, Florida, 32216, United States

Location

Altus Research, Inc.

Lake Worth, Florida, 33461, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Riverchase Dermatology and Cosmetic Surgery

Pembroke Pines, Florida, 33028-1013, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

Hamilton Research, LLC

Alpharetta, Georgia, 30022, United States

Location

Advanced Medical Research PC

Sandy Springs, Georgia, 30328, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

DS Research

Clarksville, Indiana, 47129, United States

Location

Integrated Clinical Trial Services Inc.

West Des Moines, Iowa, 50265, United States

Location

Kansas Medical Clinic, PA

Topeka, Kansas, 66614, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Skin Specialists PC

Omaha, Nebraska, 68144, 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

The Dermatology Group, PC

Verona, New Jersey, 07044, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Austin Institute for Clinical Research, Inc.

Dripping Springs, Texas, 78620, United States

Location

Austin Institute for Clinical Research, Inc - Dermatology

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research [Texas]

San Antonio, Texas, 78213, United States

Location

Center for Clinical Studies, LTD., LLP

Webster, Texas, 77598, United States

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Dr. Irina Turchin PC Inc.

Fredericton, New Brunswick, E3B 1G9, Canada

Location

CCA Medical Research

Ajax, Ontario, L1S 7K8, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, N1L 0B7, Canada

Location

Dr Wei Jing Loo Medicine Professional Corporation

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research Inc.

Mississauga, Ontario, L4Y 4C5, Canada

Location

Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office

Newmarket, Ontario, L3Y 5G8, Canada

Location

North York Research Inc. - Dermatology

North York, Ontario, M2M 4J5, Canada

Location

Dermatology Ottawa Research Centre

Ottawa, Ontario, K2C 3N2, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N4, Canada

Location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

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

Innomedica OÜ

Tallinn, 10117, Estonia

Location

Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine

Tbilisi, K'alak'i T'bilisi, 0112, Georgia

Location

LTD Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, K'alak'i T'bilisi, 0112, Georgia

Location

,,Tbilisi Cancer center"LTD

Tbilisi, K'alak'i T'bilisi, 0159, Georgia

Location

LTD Aversi Clinic

Tbilisi, K'alak'i T'bilisi, 0160, Georgia

Location

,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC

Tbilisi, 0159, Georgia

Location

Derma-Study-Center-FN

Friedrichshafen, Baden-Wurttemberg, 88045, Germany

Location

Dermazentrum Augsburg

Augsburg, Bavaria, 86179, Germany

Location

Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling

Mahlow, Brandenburg, 15831, Germany

Location

Universitätsklinikum Frankfurt am Main - Klinik für Dermatol

Frankfurt am Main, Hesse, 60590, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Praxis Hoffmann

Witten, North Rhine-Westphalia, 58453, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Saxony, 01069, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

UK-SH - Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie

Berlin, 10117, Germany

Location

Rothhaar Studien GmbH

Berlin, 10783, Germany

Location

Debreceni Egyetem Klinikai Központ Nagyerdei Campus

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Brgyógyászati és Allergológiai Magánrendelés

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

Qualiclinic Kft

Budapest, Pest County, 1036, Hungary

Location

UNOMEDICALTRIALS Kft

Budapest, Pest County, 1152, Hungary

Location

Riga 1st hospital, Clinic of Dermatology and STD

Riga, Rga, LV1001, Latvia

Location

J.Kisis LtD

Riga, Rga, LV1003, Latvia

Location

Smite Aija doctor practice in dermatology, venereology

Talsi, LV3201, Latvia

Location

Centrum Medyczne ALL-MED Badania Kliniczne

Krakow, Maopolskie, 30-033, Poland

Location

Centrum Medyczne Plejady

Krakow, Maopolskie, 30-363, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

RENEW CLINIC Spolka Jawna

Bialystok, 15-794, Poland

Location

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, 85-065, Poland

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, 85-796, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

Location

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, 31-501, Poland

Location

Centrum Medyczne PROMED

Krakow, 31-513, Poland

Location

Barbara Rewerska Diamond Clinic

Krakow, 31-559, Poland

Location

ETG Siedlce

Siedlce, 08-110, Poland

Location

RCMed Oddzial Sochaczew

Sochaczew, 96-500, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

RCMed Oddzia Warszawa

Warsaw, 00-892, Poland

Location

Centrum Medyczne Evimed

Warsaw, 02-625, Poland

Location

DermMedica Sp. z o.o.

Wroclaw, 51-318, Poland

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; 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

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigators, study personnel (with the exception of the Data Monitoring Committee (DMC), and unblinded Parexel staff supporting DMC activities and randomization list activities) and the study participants will remain blinded to treatment allocation. ABP 654 and ustekinumab will be coded and labeled in a manner that protects blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: March 24, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2024-01

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

HU (4); LA (3); GE (5); US (31); ES (4); CA (14); PL (16); DE (11)