A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Study Purpose
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.
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:
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.
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. |
NCT04607980 |
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, Lithuania, Poland, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Plaque Psoriasis |
Study Website: | View Trial Website |
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.
Arms
Experimental: 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.
Experimental: 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.
Interventions
Drug: - ABP 654
Participants will receive SC injection of ABP 654.
Drug: - Ustekinumab
Participants will receive SC injection of ustekinumab.
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
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, 35205
Status
Recruiting
Address
Alliance Dermatology and Mohs Center
Phoenix, Arizona, 85032
Status
Recruiting
Address
First OC Dermatology
Fountain Valley, California, 92708
Status
Recruiting
Address
University Clinical Trials, Inc.
San Diego, California, 92123
Status
Recruiting
Address
San Luis Dermatology and Laser Clinic - Dermatology
San Luis Obispo, California, 93405
Status
Recruiting
Address
Clinical Science Institute
Santa Monica, California, 90404
Status
Recruiting
Address
Unison Clinical Trials
Sherman Oaks, California, 91403
Status
Recruiting
Address
Revival Research
Doral, Florida, 33122
Status
Recruiting
Address
International Dermatology Research, Inc
Miami, Florida, 33144
Status
Recruiting
Address
Renstar Medical Research
Ocala, Florida, 34471
Status
Recruiting
Address
Moore Clinical Research Inc.
Tampa, Florida, 33609-2230
Status
Recruiting
Address
NorthShore University HealthSystem
Skokie, Illinois, 60077
Status
Recruiting
Address
Springfield Clinic
Springfield, Illinois, 62703-2403
Status
Recruiting
Address
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250-2041
Status
Recruiting
Address
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, 66210
Status
Recruiting
Address
DelRicht Research
Baton Rouge, Louisiana, 70809
Status
Recruiting
Address
ALLCUTIS Research, Inc.
Beverly, Massachusetts, 01915
Status
Recruiting
Address
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135
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
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
Status
Recruiting
Address
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
Status
Recruiting
Address
Bexley Dermatology Research
Bexley, Ohio, 43209-2421
Status
Recruiting
Address
Dermatologists of Southwest Ohio
Mason, Ohio, 45040-4520
Status
Recruiting
Address
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Status
Recruiting
Address
Oregon Medical Research Center
Portland, Oregon, 97223
Status
Recruiting
Address
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341
Status
Recruiting
Address
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Status
Recruiting
Address
The Skin Wellness Center PC
Knoxville, Tennessee, 37922
Status
Recruiting
Address
Studies in Dermatology, LLC
Cypress, Texas, 77433
Status
Recruiting
Address
Modern Research Associates
Dallas, Texas, 75231
Status
Recruiting
Address
Austin Institute for Clinical Research - Dermatology
Houston, Texas, 77056
Status
Recruiting
Address
Progressive Clinical Research [Texas]
San Antonio, Texas, 78213
Status
Recruiting
Address
Acclaim Dermatology
Sugar Land, Texas, 77479
International Sites
Status
Recruiting
Address
Beacon Dermatology
Calgary, Alberta, T3A 2N1
Status
Recruiting
Address
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
Status
Recruiting
Address
CCA Medical Research
Ajax, Ontario, L1S 7K8
Status
Recruiting
Address
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9
Status
Recruiting
Address
Dermatrials Research Inc
Hamilton, Ontario, L8N1Y2
Status
Recruiting
Address
Lynderm Research Inc
Markham, Ontario, L3P 1X2
Status
Recruiting
Address
DermEdge Research Inc.
Mississauga, Ontario, L5H 1G9
Status
Recruiting
Address
North Bay Dermatology Centre Inc.
North Bay, Ontario, P1B 3Z7
Status
Recruiting
Address
JRB Research Inc.
Ottawa, Ontario, K1H 7X3
Status
Recruiting
Address
Skin Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Status
Recruiting
Address
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Status
Recruiting
Address
Toronto Research Centre - Dermatology
Toronto, Ontario, M3H 5Y8
Status
Recruiting
Address
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
Status
Recruiting
Address
XLR8 Medical Research Inc.
Windsor, Ontario, N8W 1E6
Status
Recruiting
Address
Centre de Recherche dermatolog
Quebec city, Quebec, G1V 4X7
Status
Recruiting
Address
Vahlberg & Pild OÜ
Tallinn, Harjumaa, 10134
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
Tartu University Hospital
Tartu, , 50406
Status
Recruiting
Address
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
Mahlow, Brandenburg, 15831
Status
Recruiting
Address
Derma Zentrum Osnabrueck Nord
Bramsche, Niedersachsen, 49565
Status
Recruiting
Address
Hautzentrum im Jahrhunderthaus
Bochum, Nordrhein-Westfalen, 44793
Status
Recruiting
Address
CentroDerm GmbH
Wuppertal, Nordrhein-Westfalen, 42287
Status
Recruiting
Address
Brgyógyászati és Allergológiai Magánrendelés
Szolnok, Jász-Nagykun-Szolnok, 5000
Status
Recruiting
Address
UNOMEDICALTRIALS Kft
Budapest, Pest, 1135
Status
Recruiting
Address
Riga 1st hospital, Clinic of Dermatology and STD - Dermatology
Riga, Rga, LV 1001
Status
Recruiting
Address
Health Centre 4 Ltd., Diagnostics Centre
Riga, Rga, LV-1003
Status
Recruiting
Address
Health and Aesthetics Ltd
Riga, , LV-1009
Status
Recruiting
Address
Smite Aija doctor practice in dermatology, venereology
Talsi, , LV-3201
Status
Recruiting
Address
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
Kaunas, Kauno Apskritis, 50161
Status
Recruiting
Address
Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras
Vilnius, Vilniaus Apskritis, LT-08411
Status
Recruiting
Address
DermMedica Sp. z o.o.
Wroclaw, Dolnolskie, 51-318
Status
Recruiting
Address
Nasz Lekarz Osrodek Badan Klinicznych
Torun, Kujawsko-pomorskie, 87-100
Status
Recruiting
Address
Centrum Medyczne Angelius Provita
Katowice, Lskie, 40-611
Status
Recruiting
Address
Centrum Medyczne Pratia Katowice
Tychy, Lskie, 43-100
Status
Recruiting
Address
MAXXMED Centrum Zdrowia i Urody
Lublin, Lubelskie, 20-080
Status
Recruiting
Address
Centrum Medyczne ALL-MED
Krakow, Maopolskie, 30-033
Status
Recruiting
Address
Barbara Rewerska Diamond Clinic
Krakow, Maopolskie, 31-559
Status
Recruiting
Address
Medycyna Kliniczna
Warszawa, Mazowieckie, 00-660
Status
Recruiting
Address
ETG Warszawa
Warszawa, Mazowieckie, 02-793
Status
Recruiting
Address
Ambroziak Dermatologia
Warszawa, Mazowieckie, 02-953
Status
Recruiting
Address
Royalderm Agnieszka Nawrocka
Warszawa, Mazowieckie, 04-141
Status
Recruiting
Address
Zespol Naukowo-Leczn. Dermatol.Centrum Uzdrowiskowe IWOLANG
Iwonicz Zdroj, Podkarpackie, 38-440
Status
Recruiting
Address
Specderm Poznanska Sp. j.
Bialystok, Podlaskie, 15-017
Status
Recruiting
Address
ClinicMed Daniluk, Nowak Sp. J.
Bialystok, Podlaskie, 15-879
Status
Recruiting
Address
Solumed
Poznan, Wielkopolskie, 60-529
Status
Recruiting
Address
WroMedica I. Bielicka, A. Strzalkowska s.c.
Wroclaw, , 50-368
Status
Recruiting
Address
ETG Skierniewice
Skierniewice, Ódzkie, 96-100