Psoriasis Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

494

Study ID:

NCT04761627

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 84 Locations for this study

See Locations Near You

Burke Pharmaceutical Research
Hot Springs Arkansas, 71913, United States
Zenith Research Inc.
Beverly Hills California, 90212, United States
Center for Dermatology Clinical Research, Inc.
Fremont California, 94538, United States
Quest Dermatology Research
Northridge California, 91324, United States
Southern California Dermatology, Inc
Santa Ana California, 92701, United States
Encore Research Group-Jacksonville Center for Clinical Resea
Jacksonville Florida, 32216, United States
Altus Research, Inc.
Lake Worth Florida, 33461, United States
International Dermatology Research, Inc.
Miami Florida, 33144, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach Florida, 32174, United States
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines Florida, 33028, United States
Olympian Clinical Research
Tampa Florida, 33614, United States
Hamilton Research, LLC
Alpharetta Georgia, 30022, United States
Advanced Medical Research PC
Sandy Springs Georgia, 30328, United States
Dundee Dermatology
West Dundee Illinois, 60118, United States
DS Research
Clarksville Indiana, 47129, United States
Integrated Clinical Trial Services Inc.
West Des Moines Iowa, 50265, United States
Kansas Medical Clinic, PA
Topeka Kansas, 66614, United States
Clinical Pharmacology Study Group
Worcester Massachusetts, 01605, United States
Hamzavi Dermatology
Fort Gratiot Michigan, 48059, United States
Minnesota Clinical Study Center
New Brighton Minnesota, 55112, United States
MediSearch Clinical Trials
Saint Joseph Missouri, 64506, United States
Skin Specialists PC
Omaha Nebraska, 68144, United States
ActivMed Practices & Research, LLC.
Portsmouth New Hampshire, 03801, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
The Dermatology Group, PC
Verona New Jersey, 07044, United States
Wilmington Dermatology Center
Wilmington North Carolina, 28405, United States
Oregon Medical Research Center
Portland Oregon, 97223, United States
Austin Institute for Clinical Research, Inc.
Dripping Springs Texas, 78620, United States
Austin Institute for Clinical Research, Inc - Dermatology
Pflugerville Texas, 78660, United States
Progressive Clinical Research [Texas]
San Antonio Texas, 78213, United States
Center for Clinical Studies, LTD., LLP
Webster Texas, 77598, United States
Enverus Medical Research
Surrey British Columbia, V3V 0, Canada
Wiseman Dermatology Research Inc.
Winnipeg Manitoba, R3M 3, Canada
Dr. Irina Turchin PC Inc.
Fredericton New Brunswick, E3B 1, Canada
CCA Medical Research
Ajax Ontario, L1S 7, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie Ontario, L4M 7, Canada
Guelph Dermatology Research
Guelph Ontario, N1L 0, Canada
Dr Wei Jing Loo Medicine Professional Corporation
London Ontario, N6H 5, Canada
Lynderm Research Inc
Markham Ontario, L3P 1, Canada
DermEdge Research Inc.
Mississauga Ontario, L4Y 4, Canada
Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office
Newmarket Ontario, L3Y 5, Canada
North York Research Inc. - Dermatology
North York Ontario, M2M 4, Canada
Dermatology Ottawa Research Centre
Ottawa Ontario, K2C 3, Canada
Research Toronto
Toronto Ontario, M4W 2, Canada
K. Papp Clinical Research Inc.
Waterloo Ontario, N2J 1, Canada
Confido Private Medical Clinic - General Practice/Medicine
Tallinn Harjumaa, 10138, Estonia
Clinical Research Center
Tartu Tartumaa, 50106, Estonia
Tartu University Hospital
Tartu Tartumaa, 50417, Estonia
Innomedica OÜ
Tallinn , 10117, Estonia
Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
Tbilisi T'bilisi, 0112, Georgia
LTD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi T'bilisi, 0112, Georgia
,,Tbilisi Cancer center"LTD
Tbilisi T'bilisi, 0159, Georgia
LTD Aversi Clinic
Tbilisi T'bilisi, 0160, Georgia
,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC
Tbilisi , 0159, Georgia
Derma-Study-Center-FN
Friedrichshafen Baden-Württemberg, 88045, Germany
Dermazentrum Augsburg
Augsburg Bayern, 86179, Germany
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
Mahlow Brandenburg, 15831, Germany
Universitätsklinikum Frankfurt am Main - Klinik für Dermatol
Frankfurt/Main Hessen, 60590, Germany
Fachklinik Bad Bentheim
Bad Bentheim Niedersachsen, 48455, Germany
Praxis Hoffmann
Witten Nordrhein-Westfalen, 58453, Germany
Klinische Forschung Dresden GmbH
Dresden Sachsen, 01069, Germany
Universitätsklinikum Carl Gustav Carus
Dresden Sachsen, 01307, Germany
UK-SH - Lübeck
Lübeck Schleswig-Holstein, 23538, Germany
Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
Berlin , 10117, Germany
Rothhaar Studien GmbH
Berlin , 10783, Germany
Debreceni Egyetem Klinikai Központ Nagyerdei Campus
Debrecen Hajdú-Bihar, 4032, Hungary
Brgyógyászati és Allergológiai Magánrendelés
Szolnok Jász-Nagykun-Szolnok, 5000, Hungary
Qualiclinic Kft
Budapest Pest, 1036, Hungary
UNOMEDICALTRIALS Kft
Budapest Pest, 1152, Hungary
Riga 1st hospital, Clinic of Dermatology and STD
Riga Rga, LV100, Latvia
J.Kisis LtD
Riga Rga, LV100, Latvia
Smite Aija doctor practice in dermatology, venereology
Talsi , LV320, Latvia
Centrum Medyczne ALL-MED Badania Kliniczne
Krakow Maopolskie, 30-03, Poland
Centrum Medyczne Plejady
Krakow Maopolskie, 30-36, Poland
MICS Centrum Medyczne Warszawa
Warszawa Mazowieckie, 00-87, Poland
RENEW CLINIC Spolka Jawna
Bialystok , 15-79, Poland
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz , 85-06, Poland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz , 85-79, Poland
Centrum Medyczne Pratia Gdynia
Gdynia , 81-33, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow , 31-50, Poland
Centrum Medyczne PROMED
Krakow , 31-51, Poland
Barbara Rewerska Diamond Clinic
Krakow , 31-55, Poland
ETG Siedlce
Siedlce , 08-11, Poland
RCMed Oddzial Sochaczew
Sochaczew , 96-50, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin , 71-43, Poland
RCMed Oddzia Warszawa
Warszawa , 00-89, Poland
Centrum Medyczne Evimed
Warszawa , 02-62, Poland
DermMedica Sp. z o.o.
Wroclaw , 51-31, Poland

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

494

Study ID:

NCT04761627

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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