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 |
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.
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, Georgia, 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 |
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
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.
Status
Recruiting
Address
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Status
Recruiting
Address
Zenith Research Inc.
Beverly Hills, California, 90212
Status
Recruiting
Address
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Status
Recruiting
Address
Quest Dermatology Research
Northridge, California, 91324-4669
Status
Recruiting
Address
Southern California Dermatology, Inc
Santa Ana, California, 92701
Status
Recruiting
Address
Clearlyderm Dermatology
Boca Raton, Florida, 33428
Status
Recruiting
Address
Encore Research Group-Jacksonville Center for Clinical Resea
Jacksonville, Florida, 32216
Status
Recruiting
Address
International Dermatology Research, Inc.
Miami, Florida, 33144
Status
Recruiting
Address
Altus Research, Inc.
Palm Springs, Florida, 33461
Status
Recruiting
Address
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, 33028-1013
Status
Recruiting
Address
Olympian Clinical Research
Tampa, Florida, 33614
Status
Recruiting
Address
Hamilton Research, LLC
Alpharetta, Georgia, 30022
Status
Recruiting
Address
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Status
Recruiting
Address
Dundee Dermatology
West Dundee, Illinois, 60118
Status
Recruiting
Address
DS Research
Clarksville, Indiana, 47129
Status
Recruiting
Address
DS Research
Corydon, Indiana, 47112-2174
Status
Recruiting
Address
Integrated Clinical Trial Services Inc.
West Des Moines, Iowa, 50265
Status
Recruiting
Address
Kansas Medical Clinic, PA
Topeka, Kansas, 66614
Status
Recruiting
Address
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
Status
Recruiting
Address
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Status
Recruiting
Address
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Status
Recruiting
Address
Skin Specialists PC
Omaha, Nebraska, 68144
Status
Recruiting
Address
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, 03801
Status
Recruiting
Address
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Status
Recruiting
Address
The Dermatology Group, PC
Verona, New Jersey, 07044
Status
Recruiting
Address
Buffalo Medical Group, PC
Buffalo, New York, 14221
Status
Recruiting
Address
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28209
Status
Recruiting
Address
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
Status
Recruiting
Address
Oregon Medical Research Center
Portland, Oregon, 97223
Status
Recruiting
Address
Austin Institute for Clinical Research, Inc.
Dripping Springs, Texas, 78620
Status
Recruiting
Address
Austin Institute for Clinical Research, Inc - Dermatology
Pflugerville, Texas, 78660
Status
Recruiting
Address
Stephen Miller, MD, PA
San Antonio, Texas, 78249
Status
Recruiting
Address
Center for Clinical Studies, LTD., LLP
Webster, Texas, 77598
Status
Recruiting
Address
Dermatology of Seattle
Burien, Washington, 98168
International Sites
Status
Recruiting
Address
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
Status
Recruiting
Address
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
Status
Recruiting
Address
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, E3B 1G9
Status
Recruiting
Address
CCA Medical Research
Ajax, Ontario, L1S 7K8
Status
Recruiting
Address
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Status
Recruiting
Address
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
Status
Recruiting
Address
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, N6H 5L5
Status
Recruiting
Address
Lynderm Research Inc
Markham, Ontario, L3P 1X3
Status
Recruiting
Address
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Status
Recruiting
Address
Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office
Newmarket, Ontario, L3Y 5G8
Status
Recruiting
Address
North York Research Inc. - Dermatology
North York, Ontario, M2M 4J5
Status
Recruiting
Address
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2
Status
Recruiting
Address
Research Toronto
Toronto, Ontario, M4W 2N4
Status
Recruiting
Address
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
Status
Recruiting
Address
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 0H6
Status
Recruiting
Address
Confido Private Medical Clinic - General Practice/Medicine
Tallinn, Harjumaa, 10138
Status
Recruiting
Address
Clinical Research Center
Tartu, Tartumaa, 50106
Status
Recruiting
Address
Innomedica OÜ
Tallinn, , 10117
Status
Recruiting
Address
Tartu University Hospital
Tartu, , 50417
Status
Recruiting
Address
Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
Tbilisi, T'bilisi, 0112
Status
Recruiting
Address
LTD Aversi Clinic
Tbilisi, T'bilisi, 0160
Status
Recruiting
Address
LTD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, , 0112
Status
Recruiting
Address
,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC
Tbilisi, , 0159
Status
Recruiting
Address
,,Tbilisi Cancer center"LTD
Tbilisi, , 0159
Status
Recruiting
Address
Derma-Study-Center-FN
Friedrichshafen, Baden-Württemberg, 88045
Status
Recruiting
Address
Licca Clinical Research Institute
Augsburg, Bayern, 86179
Status
Recruiting
Address
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
Mahlow, Brandenburg, 15831
Status
Recruiting
Address
Universitätsklinikum Frankfurt am Main - Klinik für Dermatol
Frankfurt/Main, Hessen, 60590
Status
Recruiting
Address
Fachklinik Bad Bentheim
Bad Bentheim, Niedersachsen, 48455
Status
Recruiting
Address
Praxis Hoffmann
Witten, Nordrhein-Westfalen, 58453
Status
Recruiting
Address
Klinische Forschung Dresden GmbH
Dresden, Sachsen, 01069
Status
Recruiting
Address
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen, 01307
Status
Recruiting
Address
UK-SH - Lübeck
Lübeck, Schleswig-Holstein, 23538
Status
Recruiting
Address
Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
Berlin, , 10117
Status
Recruiting
Address
Rothhaar Studien GmbH
Berlin, , 10783
Status
Recruiting
Address
Debreceni Egyetem Klinikai Központ Nagyerdei Campus
Debrecen, Hajdú-Bihar, 4032
Status
Recruiting
Address
Brgyógyászati és Allergológiai Magánrendelés
Szolnok, Jász-Nagykun-Szolnok, 5000
Status
Recruiting
Address
Qualiclinic Kft
Budapest, Pest, 1036
Status
Recruiting
Address
UNOMEDICALTRIALS Kft
Budapest, Pest, 1135
Status
Recruiting
Address
Riga 1st hospital, Clinic of Dermatology and STD
Riga, Rga, LV1001
Status
Recruiting
Address
Smite Aija doctor practice in dermatology, venereology
Talsi, , LV3201
Status
Recruiting
Address
Centrum Medyczne ALL-MED
Krakow, Maopolskie, 30-033
Status
Recruiting
Address
Centrum Medyczne Plejady
Krakow, Maopolskie, 30-363
Status
Recruiting
Address
Medycyna Kliniczna
Warszawa, Mazowieckie, 00-874
Status
Recruiting
Address
RENEW CLINIC Spolka Jawna
Bialystok, , 15-794
Status
Recruiting
Address
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, , 85-065
Status
Recruiting
Address
Centrum Medyczne PRATIA Bydgoszcz
Bydgoszcz, , 85-796
Status
Recruiting
Address
Centrum Medyczne Pratia Gdynia
Gdynia, , 81-338
Status
Recruiting
Address
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , 31-501
Status
Recruiting
Address
Centrum Medyczne PROMED
Krakow, , 31-513
Status
Recruiting
Address
Barbara Rewerska Diamond Clinic
Krakow, , 31-559
Status
Recruiting
Address
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , 71-434
Status
Recruiting
Address
Centrum Medyczne Evimed
Warszawa, , 02-625
Status
Recruiting
Address
DermMedica Sp. z o.o.
Wroclaw, , 51-318
Status
Recruiting
Address
Hospital Universitario Reina Sofia
Córdoba, Andalucía, 14004
Status
Recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, , 28041