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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
- Sexually active participants and their partners who are of childbearing potential and not agreeing to use adequate protocol defined contraception methods while participating in the study and for 5 months after the last dose of investigational product

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04761627
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Estonia, Germany, Hungary, Latvia, Poland, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Additional Details

This is a multi-center study and will enroll approximately 480 participants. After eligibility confirmation, all participants will be randomized in a 1:1 ratio into 2 treatment arms: continued use of ustekinumab or multiple switches between ustekinumab and ABP 654 at Week 28. The randomization will be stratified by prior biologic use for psoriasis (yes versus [vs] no) at baseline (Week 0), geographic region, and baseline (Week 0) body weight. All participants will receive an initial 3 doses of ustekinumab on Day 1 (Week 0), Week 4 and Week 16. At Week 28, participants will be randomized to continue on ustekinumab or switching between ABP 654 and ustekinumab every 12 weeks. At Week 28, efficacy assessments will be conducted including evaluation of Psoriasis and Area Severity Index (PASI). Participants who do not achieve PASI 50 response or better improvement at Week 28 will be considered as run-in failures and will not be randomized at Week 28; these participants will complete End of Study procedures at Week 28. The run-in period will occur from Day 1 until randomization at Week 28. Those unable to complete the Week 28 visit or did not have a PASI assessment completed at Week 28 will be discontinued from the study. The total duration of study participation for each participant will be 68 weeks, with up to 4 weeks for screening and 64 weeks after the first investigational product administration.

Arms & Interventions

Arms

Active Comparator: Continued-use Group (Ustekinumab)

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

Experimental: Switching Group (Ustekinumab - ABP 654)

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.

Interventions

Drug: - Ustekinumab

Participants will receive subcutaneous (SC) injection of ustekinumab.

Drug: - ABP 654

Participants will receive SC injection of ABP 654.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Burke Pharmaceutical Research, Hot Springs, Arkansas

Status

Recruiting

Address

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913

Zenith Research Inc., Beverly Hills, California

Status

Recruiting

Address

Zenith Research Inc.

Beverly Hills, California, 90212

Fremont, California

Status

Recruiting

Address

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538

Quest Dermatology Research, Northridge, California

Status

Recruiting

Address

Quest Dermatology Research

Northridge, California, 91324-4669

Southern California Dermatology, Inc, Santa Ana, California

Status

Recruiting

Address

Southern California Dermatology, Inc

Santa Ana, California, 92701

Clearlyderm Dermatology, Boca Raton, Florida

Status

Recruiting

Address

Clearlyderm Dermatology

Boca Raton, Florida, 33428

International Dermatology Research, Inc., Miami, Florida

Status

Recruiting

Address

International Dermatology Research, Inc.

Miami, Florida, 33144

Altus Research, Inc., Palm Springs, Florida

Status

Recruiting

Address

Altus Research, Inc.

Palm Springs, Florida, 33461

Pembroke Pines, Florida

Status

Recruiting

Address

Riverchase Dermatology and Cosmetic Surgery

Pembroke Pines, Florida, 33028-1013

Olympian Clinical Research, Tampa, Florida

Status

Recruiting

Address

Olympian Clinical Research

Tampa, Florida, 33614

Hamilton Research, LLC, Alpharetta, Georgia

Status

Recruiting

Address

Hamilton Research, LLC

Alpharetta, Georgia, 30022

Advanced Medical Research PC, Sandy Springs, Georgia

Status

Recruiting

Address

Advanced Medical Research PC

Sandy Springs, Georgia, 30328

Dundee Dermatology, West Dundee, Illinois

Status

Recruiting

Address

Dundee Dermatology

West Dundee, Illinois, 60118

Integrated Clinical Trial Services Inc., West Des Moines, Iowa

Status

Recruiting

Address

Integrated Clinical Trial Services Inc.

West Des Moines, Iowa, 50265

Kansas Medical Clinic, PA, Topeka, Kansas

Status

Recruiting

Address

Kansas Medical Clinic, PA

Topeka, Kansas, 66614

Clinical Pharmacology Study Group, Worcester, Massachusetts

Status

Recruiting

Address

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605

Hamzavi Dermatology, Fort Gratiot, Michigan

Status

Recruiting

Address

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059

Skin Specialists PC, Omaha, Nebraska

Status

Recruiting

Address

Skin Specialists PC

Omaha, Nebraska, 68144

ActivMed Practices & Research, LLC., Portsmouth, New Hampshire

Status

Recruiting

Address

ActivMed Practices & Research, LLC.

Portsmouth, New Hampshire, 03801

East Windsor, New Jersey

Status

Recruiting

Address

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520

The Dermatology Group, PC, Verona, New Jersey

Status

Recruiting

Address

The Dermatology Group, PC

Verona, New Jersey, 07044

Buffalo Medical Group, PC, Buffalo, New York

Status

Recruiting

Address

Buffalo Medical Group, PC

Buffalo, New York, 14221

OnSite Clinical Solutions, LLC, Charlotte, North Carolina

Status

Recruiting

Address

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, 28209

Wilmington Dermatology Center, Wilmington, North Carolina

Status

Recruiting

Address

Wilmington Dermatology Center

Wilmington, North Carolina, 28405

Oregon Medical Research Center, Portland, Oregon

Status

Recruiting

Address

Oregon Medical Research Center

Portland, Oregon, 97223

Dripping Springs, Texas

Status

Recruiting

Address

Austin Institute for Clinical Research, Inc.

Dripping Springs, Texas, 78620

Pflugerville, Texas

Status

Recruiting

Address

Austin Institute for Clinical Research, Inc - Dermatology

Pflugerville, Texas, 78660

Stephen Miller, MD, PA, San Antonio, Texas

Status

Recruiting

Address

Stephen Miller, MD, PA

San Antonio, Texas, 78249

Center for Clinical Studies, LTD., LLP, Webster, Texas

Status

Recruiting

Address

Center for Clinical Studies, LTD., LLP

Webster, Texas, 77598

Dermatology of Seattle, Burien, Washington

Status

Recruiting

Address

Dermatology of Seattle

Burien, Washington, 98168

International Sites

Enverus Medical Research, Surrey, British Columbia, Canada

Status

Recruiting

Address

Enverus Medical Research

Surrey, British Columbia, V3V 0C6

Dr. Irina Turchin PC Inc., Fredericton, New Brunswick, Canada

Status

Recruiting

Address

Dr. Irina Turchin PC Inc.

Fredericton, New Brunswick, E3B 1G9

CCA Medical Research, Ajax, Ontario, Canada

Status

Recruiting

Address

CCA Medical Research

Ajax, Ontario, L1S 7K8

Barrie, Ontario, Canada

Status

Recruiting

Address

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1

Guelph Dermatology Research, Guelph, Ontario, Canada

Status

Recruiting

Address

Guelph Dermatology Research

Guelph, Ontario, N1L 0B7

London, Ontario, Canada

Status

Recruiting

Address

Dr Wei Jing Loo Medicine Professional Corporation

London, Ontario, N6H 5L5

Lynderm Research Inc, Markham, Ontario, Canada

Status

Recruiting

Address

Lynderm Research Inc

Markham, Ontario, L3P 1X2

DermEdge Research Inc., Mississauga, Ontario, Canada

Status

Recruiting

Address

DermEdge Research Inc.

Mississauga, Ontario, L5H 1G9

North York Research Inc. - Dermatology, North York, Ontario, Canada

Status

Recruiting

Address

North York Research Inc. - Dermatology

North York, Ontario, M2M 4J5

Dermatology Ottawa Research Centre, Ottawa, Ontario, Canada

Status

Recruiting

Address

Dermatology Ottawa Research Centre

Ottawa, Ontario, K2C 3N2

Research Toronto, Toronto, Ontario, Canada

Status

Recruiting

Address

Research Toronto

Toronto, Ontario, M4W 2N4

K. Papp Clinical Research Inc., Waterloo, Ontario, Canada

Status

Recruiting

Address

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4

Tallinn, Harjumaa, Estonia

Status

Recruiting

Address

Confido Private Medical Clinic - General Practice/Medicine

Tallinn, Harjumaa, 10138

Clinical Research Center, Tartu, Tartumaa, Estonia

Status

Recruiting

Address

Clinical Research Center

Tartu, Tartumaa, 50106

Innomedica OÜ, Tallinn, Estonia

Status

Recruiting

Address

Innomedica OÜ

Tallinn, , 10117

Mahlow, Brandenburg, Germany

Status

Recruiting

Address

Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling

Mahlow, Brandenburg, 15831

Fachklinik Bad Bentheim, Bad Bentheim, Niedersachsen, Germany

Status

Recruiting

Address

Fachklinik Bad Bentheim

Bad Bentheim, Niedersachsen, 48455

UK-SH - Lübeck, Lübeck, Schleswig-Holstein, Germany

Status

Recruiting

Address

UK-SH - Lübeck

Lübeck, Schleswig-Holstein, 23538

Szolnok, Jász-Nagykun-Szolnok, Hungary

Status

Recruiting

Address

Brgyógyászati és Allergológiai Magánrendelés

Szolnok, Jász-Nagykun-Szolnok, 5000

Qualiclinic Kft, Budapest, Pest, Hungary

Status

Recruiting

Address

Qualiclinic Kft

Budapest, Pest, 1036

UNOMEDICALTRIALS Kft, Budapest, Pest, Hungary

Status

Recruiting

Address

UNOMEDICALTRIALS Kft

Budapest, Pest, 1135

Derma-B Kft, Debrecen, Hungary

Status

Recruiting

Address

Derma-B Kft

Debrecen, , 4026

Riga, Rga, Latvia

Status

Recruiting

Address

Riga 1st hospital, Clinic of Dermatology and STD

Riga, Rga, LV1001

J.Kisis LtD, Riga, Rga, Latvia

Status

Recruiting

Address

J.Kisis LtD

Riga, Rga, LV1003

Talsi, Latvia

Status

Recruiting

Address

Smite Aija doctor practice in dermatology, venereology

Talsi, , LV3201

Centrum Medyczne ALL-MED, Krakow, Maopolskie, Poland

Status

Recruiting

Address

Centrum Medyczne ALL-MED

Krakow, Maopolskie, 30-033

Centrum Medyczne Plejady, Krakow, Maopolskie, Poland

Status

Recruiting

Address

Centrum Medyczne Plejady

Krakow, Maopolskie, 30-363

ETG Siedlce, Siedlce, Mazowieckie, Poland

Status

Recruiting

Address

ETG Siedlce

Siedlce, Mazowieckie, 08-110

Medycyna Kliniczna, Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

Medycyna Kliniczna

Warszawa, Mazowieckie, 00-874

RENEW CLINIC Spolka Jawna, Bialystok, Poland

Status

Recruiting

Address

RENEW CLINIC Spolka Jawna

Bialystok, , 15-794

Nasz Lekarz Osrodek Badan Klinicznych, Bydgoszcz, Poland

Status

Recruiting

Address

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, , 85-065

Centrum Medyczne PRATIA Bydgoszcz, Bydgoszcz, Poland

Status

Recruiting

Address

Centrum Medyczne PRATIA Bydgoszcz

Bydgoszcz, , 85-796

Centrum Medyczne Pratia Gdynia, Gdynia, Poland

Status

Recruiting

Address

Centrum Medyczne Pratia Gdynia

Gdynia, , 81-338

Centrum Medyczne PROMED, Krakow, Poland

Status

Recruiting

Address

Centrum Medyczne PROMED

Krakow, , 31-513

Barbara Rewerska Diamond Clinic, Krakow, Poland

Status

Recruiting

Address

Barbara Rewerska Diamond Clinic

Krakow, , 31-559

Nowa Sol, Poland

Status

Recruiting

Address

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sol, , 67-100

RCMed, Sochaczew, Poland

Status

Recruiting

Address

RCMed

Sochaczew, , 96-500

Szczecin, Poland

Status

Recruiting

Address

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , 71-434

RCMed Oddzia Warszawa, Warszawa, Poland

Status

Recruiting

Address

RCMed Oddzia Warszawa

Warszawa, , 00-892

DermMedica Sp. z o.o., Wroclaw, Poland

Status

Recruiting

Address

DermMedica Sp. z o.o.

Wroclaw, , 51-318

Hospital Universitario Reina Sofia, Córdoba, Andalucía, Spain

Status

Recruiting

Address

Hospital Universitario Reina Sofia

Córdoba, Andalucía, 14004

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