A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT04607980
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 563
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
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
- Participants likely not to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group B (Ustekinumab - ABP 654) 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. Treatment Group A (ABP 654) 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. Treatment Group B (Ustekinumab - ABP 654) Ustekinumab 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.
- Primary Outcome Measures
Name Time Method PASI Percent Change From Baseline to Week 12 Baseline (Day 1 [Week 0]) and Week 12 The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
- Secondary Outcome Measures
Name Time Method PASI Percent Change at Other Timepoints Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (End of Study [EOS]) The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
Percentage of Participants With PASI 75 Response Throughout the Study Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (EOS) Reduction in disease was measured by PASI score. The PASI 75 response is a 75% or greater improvement (reduction in disease \[PASI 75\]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654 Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) A participant was considered to have developed ADAs if they:
* had a positive post-baseline binding or neutralizing antibody result with a negative or no result at Baseline or
* had a positive post-baseline binding or neutralizing antibody result with a negative or no result prior to the first dose in the post Week 28 study period.Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52 Baseline (Day 1 [Week 0]), Week 12 and Week 52 (EOS) The percentage of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represents roughly 1% of the body's surface.
Number of Participants With Events of Interests (EOIs) Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) The EOIs pre-specified for this study included serious systemic hypersensitivity reactions, facial palsy, pustular psoriasis, erythrodermic psoriasis, serious infections (including mycobacterial and salmonella infections), malignancy, cardiovascular events, reversible posterior leukoencephalopathy syndrome, serious depression including suicidality, and venous thromboembolism.
Percentage of Participants With PASI 100 Response Throughout the Study Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (EOS) Reduction in disease was measured by PASI score. The PASI 100 response is a 100% improvement (reduction in disease \[PASI 100\]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52 Week 12 and Week 52 (EOS) The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response was defined as a sPGA value of clear (score 0) or almost clear (score 1). Higher scores represent worse symptom severity.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) TEAEs were summarized by actual treatment received. For each category, participants were included only once, even if they experienced multiple events in that category.
Trial Locations
- Locations (84)
Toronto Research Centre - Dermatology
🇨🇦Toronto, Ontario, Canada
First OC Dermatology
🇺🇸Fountain Valley, California, United States
DermEdge Research Inc.
🇨🇦Mississauga, Ontario, Canada
Austin Institute for Clinical Research - Dermatology
🇺🇸Houston, Texas, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
University Clinical Trials, Inc.
🇺🇸San Diego, California, United States
XLR8 Medical Research Inc.
🇨🇦Windsor, Ontario, Canada
Confido Private Medical Clinic - General Practice/Medicine
🇪🇪Tallinn, Harjumaa, Estonia
Epiphany Dermatology of Kansas, LLC
🇺🇸Overland Park, Kansas, United States
Kingsway Clinical Research
🇨🇦Etobicoke, Ontario, Canada
North Bay Dermatology Centre Inc.
🇨🇦North Bay, Ontario, Canada
Psoriasis Treatment Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States
UNOMEDICALTRIALS Kft
🇭🇺Budapest, Pest, Hungary
J.Kisis LtD
🇱🇻Riga, Rga, Latvia
The Skin Wellness Center PC
🇺🇸Knoxville, Tennessee, United States
Moore Clinical Research Inc.
🇺🇸Tampa, Florida, United States
Beacon Dermatology
🇨🇦Calgary, Alberta, Canada
Dr. Chih-ho Hong Medical Inc.
🇨🇦Surrey, British Columbia, Canada
Revival Research
🇺🇸Doral, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Vahlberg & Pild OÜ
🇪🇪Tallinn, Harjumaa, Estonia
CentroDerm GmbH
🇩🇪Wuppertal, Nordrhein-Westfalen, Germany
Health Centre 4 Ltd., Diagnostics Centre
🇱🇻Riga, Rga, Latvia
Medycyna Kliniczna
🇵🇱Warszawa, Mazowieckie, Poland
Centrum Zdrowia i Urody Maxxmed
🇵🇱Lublin, Poland
Nasz Lekarz Osrodek Badan Klinicznych
🇵🇱Torun, Poland
DelRicht Research
🇺🇸Baton Rouge, Louisiana, United States
Alliance Dermatology and Mohs Center
🇺🇸Phoenix, Arizona, United States
Health and Aesthetics Ltd
🇱🇻Riga, Latvia
Centrum Medyczne ALL-MED
🇵🇱Krakow, Maopolskie, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c.
🇵🇱Wroclaw, Poland
International Dermatology Research, Inc
🇺🇸Miami, Florida, United States
ALLCUTIS Research, LLC.
🇺🇸Beverly, Massachusetts, United States
Skin Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
Metro Boston Clinical Partners
🇺🇸Brighton, Massachusetts, United States
Tartu University Hospital
🇪🇪Tartu, Tartumaa, Estonia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
🇱🇹Kaunas, Kauno Apskritis, Lithuania
Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras
🇱🇹Vilnius, Vilniaus Apskritis, Lithuania
ETG Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Zespol Naukowo-Leczniczy Iwolang sp. z.o.o.
🇵🇱Iwonicz Zdroj, Podkarpackie, Poland
Specderm Poznanska Sp. j.
🇵🇱Bialystok, Podlaskie, Poland
Barbara Rewerska Diamond Clinic
🇵🇱Krakow, Poland
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
ActivMed Practices & Research, LLC.
🇺🇸Portsmouth, New Hampshire, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Centre de Recherche dermatolog
🇨🇦Quebec city, Quebec, Canada
Clinical Research Center
🇪🇪Tartu, Tartumaa, Estonia
Riga 1st hospital, Clinic of Dermatology and STD
🇱🇻Riga, Rga, Latvia
ClinicMed Daniluk, Nowak Sp. J.
🇵🇱Bialystok, Podlaskie, Poland
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
Total Skin and Beauty Dermatology Center PC
🇺🇸Birmingham, Alabama, United States
San Luis Dermatology and Laser Clinic - Dermatology
🇺🇸San Luis Obispo, California, United States
Unison Clinical Trials
🇺🇸Sherman Oaks, California, United States
NorthShore University HealthSystem
🇺🇸Skokie, Illinois, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Wilmington Dermatology Center
🇺🇸Wilmington, North Carolina, United States
Bexley Dermatology Research
🇺🇸Bexley, Ohio, United States
Dermatology Consulting Services, PLLC
🇺🇸High Point, North Carolina, United States
Dermatologists of Southwest Ohio
🇺🇸Mason, Ohio, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
The Pennsylvania Centre for Dermatology, LLC
🇺🇸Exton, Pennsylvania, United States
Center for Clinical Studies
🇺🇸Cypress, Texas, United States
Modern Research Associates
🇺🇸Dallas, Texas, United States
CCA Medical Research
🇨🇦Ajax, Ontario, Canada
Acclaim Dermatology
🇺🇸Sugar Land, Texas, United States
Progressive Clinical Research [Texas]
🇺🇸San Antonio, Texas, United States
Dermatrials Research Inc
🇨🇦Hamilton, Ontario, Canada
JRB Research Inc.
🇨🇦Ottawa, Ontario, Canada
K. Papp Clinical Research Inc.
🇨🇦Waterloo, Ontario, Canada
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
🇩🇪Mahlow, Brandenburg, Germany
Derma Zentrum Osnabrueck Nord
🇩🇪Bramsche, Niedersachsen, Germany
Hautzentrum im Jahrhunderthaus
🇩🇪Bochum, Nordrhein-Westfalen, Germany
Brgyógyászati és Allergológiai Magánrendelés
🇭🇺Szolnok, Jász-Nagykun-Szolnok, Hungary
Smite Aija doctor practice in dermatology, venereology
🇱🇻Talsi, Latvia
Royalderm Agnieszka Nawrocka
🇵🇱Warszawa, Mazowieckie, Poland
Centrum Medyczne Pratia Katowice
🇵🇱Katowice, Poland
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
ETG Lublin
🇵🇱Lublin, Poland
Solumed
🇵🇱Poznan, Poland
DermMedica Sp. z o.o.
🇵🇱Wroclaw, Poland
Klinika Ambroziak Dermatologia
🇵🇱Warszawa, Poland
ETG Skierniewice
🇵🇱Skierniewice, Ódzkie, Poland
Clinical Science Institute
🇺🇸Santa Monica, California, United States