PsoriasisPhase 3NCT04761627
A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing Ustekinumab and ABP 654 in people with Psoriasis, run by Amgen at 88 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Ustekinumab and ABP 654
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 88 sitesin 8 countries
- Study dates
- 24 Mar 2021to 28 Feb 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
88 sites in 8 countries.
88 sites in 8 countries
United States31 sites
Hamilton Research, LLC
Alpharetta, Georgia, 30022
Zenith Research Inc.
Beverly Hills, California, 90212
DS Research
Clarksville, Indiana, 47129
Austin Institute for Clinical Research, Inc.
Dripping Springs, Texas, 78620
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Encore Research Group-Jacksonville Center for Clinical Resea
Jacksonville, Florida, 32216
Altus Research, Inc.
Lake Worth, Florida, 33461
International Dermatology Research, Inc.
Miami, Florida, 33144
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Quest Dermatology Research
Northridge, California, 91324-4669
Skin Specialists PC
Omaha, Nebraska, 68144
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach, Florida, 32174
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, 33028-1013
Austin Institute for Clinical Research, Inc - Dermatology
Pflugerville, Texas, 78660
Oregon Medical Research Center
Portland, Oregon, 97223
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, 03801
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Progressive Clinical Research [Texas]
San Antonio, Texas, 78213
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Southern California Dermatology, Inc
Santa Ana, California, 92701
Olympian Clinical Research
Tampa, Florida, 33614
Kansas Medical Clinic, PA
Topeka, Kansas, 66614
The Dermatology Group, PC
Verona, New Jersey, 07044
Center for Clinical Studies, LTD., LLP
Webster, Texas, 77598
Integrated Clinical Trial Services Inc.
West Des Moines, Iowa, 50265
Dundee Dermatology
West Dundee, Illinois, 60118
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
Poland16 sites
RENEW CLINIC Spolka Jawna
Bialystok, 15-794
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, 85-796
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338
Centrum Medyczne ALL-MED Badania Kliniczne
Krakow, Maopolskie, 30-033
Centrum Medyczne Plejady
Krakow, Maopolskie, 30-363
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501
Centrum Medyczne PROMED
Krakow, 31-513
Barbara Rewerska Diamond Clinic
Krakow, 31-559
ETG Siedlce
Siedlce, 08-110
RCMed Oddzial Sochaczew
Sochaczew, 96-500
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
MICS Centrum Medyczne Warszawa
Warsaw, Masovian Voivodeship, 00-874
RCMed Oddzia Warszawa
Warsaw, 00-892
Centrum Medyczne Evimed
Warsaw, 02-625
DermMedica Sp. z o.o.
Wroclaw, 51-318
Canada14 sites
CCA Medical Research
Ajax, Ontario, L1S 7K8
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, E3B 1G9
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, N6H 5L5
Lynderm Research Inc
Markham, Ontario, L3P 1X3
DermEdge Research Inc.
Mississauga, Ontario, L4Y 4C5
Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office
Newmarket, Ontario, L3Y 5G8
North York Research Inc. - Dermatology
North York, Ontario, M2M 4J5
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
Research Toronto
Toronto, Ontario, M4W 2N4
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
Germany11 sites
Dermazentrum Augsburg
Augsburg, Bavaria, 86179
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455
Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
Berlin, 10117
Rothhaar Studien GmbH
Berlin, 10783
Klinische Forschung Dresden GmbH
Dresden, Saxony, 01069
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307
Universitätsklinikum Frankfurt am Main - Klinik für Dermatol
Frankfurt am Main, Hesse, 60590
Derma-Study-Center-FN
Friedrichshafen, Baden-Wurttemberg, 88045
UK-SH - Lübeck
Lübeck, Schleswig-Holstein, 23538
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
Mahlow, Brandenburg, 15831
Praxis Hoffmann
Witten, North Rhine-Westphalia, 58453
Georgia5 sites
Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
Tbilisi, K'alak'i T'bilisi, 0112
LTD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, K'alak'i T'bilisi, 0112
,,Tbilisi Cancer center"LTD
Tbilisi, K'alak'i T'bilisi, 0159
LTD Aversi Clinic
Tbilisi, K'alak'i T'bilisi, 0160
,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC
Tbilisi, 0159
Estonia4 sites
Confido Private Medical Clinic - General Practice/Medicine
Tallinn, Harju, 10138
Innomedica OÜ
Tallinn, 10117
Clinical Research Center
Tartu, Tartu, 50106
Tartu University Hospital
Tartu, Tartu, 50417
Hungary4 sites
Qualiclinic Kft
Budapest, Pest County, 1036
UNOMEDICALTRIALS Kft
Budapest, Pest County, 1152
Debreceni Egyetem Klinikai Központ Nagyerdei Campus
Debrecen, Hajdú-Bihar, 4032
Brgyógyászati és Allergológiai Magánrendelés
Szolnok, Jász-Nagykun-Szolnok, 5000
Latvia3 sites
Riga 1st hospital, Clinic of Dermatology and STD
Riga, Rga, LV1001
J.Kisis LtD
Riga, Rga, LV1003
Smite Aija doctor practice in dermatology, venereology
Talsi, LV3201
About this study
Official title: A Multicenter, Randomized, Double-blinded Study Evaluating the Pharmacokinetics, Efficacy and Safety of Multiple Switches Between Ustekinumab and ABP 654 Compared With Continued Use of Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
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.
Read the detailed 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.
- Conditions
- Psoriasis
- Being tested
- Ustekinumab, ABP 654
- Keywords
- Psoriasis, Biosimilar, Psoriasis area and severity index, Ustekinumab, Skin Diseases, Dermatologic Agents, Papulosquamous
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called Stelara®
Participants will receive subcutaneous (SC) injection of ustekinumab.
ABP 654Drug
Participants will receive SC injection of ABP 654.
| Study group | Role | What they receive |
|---|---|---|
| Continued-use Group (Ustekinumab) | Active comparator | Participants will receive subcutaneous injection of ustekinumab up to Week 52. Receives: Drug: Ustekinumab |
| Switching Group (Ustekinumab - ABP 654) | Experimental | 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. Receives: Drug: Ustekinumab; Drug: ABP 654 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64
AUCtau from time 0 (week 52) over the dosing interval up to week 64 is presented. Pharmacokinetic (PK) parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.
Measured: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64
Cmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.
Measured: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Secondary outcomes (8)
Time of Maximum Serum Concentration (Tmax) Between Week 52 and Week 64
Tmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.
Measured: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52
Ctrough,ss at weeks 28, 40, and 52 are presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.
Measured: Blood samples were taken pre-dose week 28, week 40, and week 52
PASI Percent Improvement From Baseline at Week 64
The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI percent improvement is defined as 100 x (value at baseline - value at post-baseline visit) / value at baseline. A positive value indicates PASI improvement. Baseline data were derived based on observed data and at week 64 were derived based on multiple imputation (MI) data. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.
Measured: Baseline (day 1) and week 64
PASI 75 Response at Week 64
The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting or surpassing a pre-specified threshold for percent improvement in PASI score compared to the baseline PASI score. An improvement of at least 75% qualified a participant as being a PASI 75 responder. Missing PASI 75 responses at week 64 were imputed by non-responder imputation (NRI). Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.
Measured: Baseline (day 1) and week 64
PASI 100 Response at Week 64
The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting or surpassing a pre-specified threshold for percent improvement in PASI score compared to the baseline PASI score. An improvement of 100% qualified a participant as being a PASI 100 responder. Missing PASI 100 responses at week 64 were imputed by NRI. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.
Measured: Baseline (day 1) and week 64
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Post-randomization Period
TEAEs during the post-randomization period were defined as AEs that started on or after the first dose of investigational product post-randomization and prior to the end of study. The number of participants who experienced any TEAE, and who experienced a serious TEAE are presented. A serious TEAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or other medically important serious event.
Measured: Week 28 to week 64
Number of Participants With Events of Interest (EOI): Post-randomization Period
The treatment-emergent EOIs prespecified 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 (RPLS), serious depression including suicidality, and venous thromboembolism.
Measured: Week 28 to week 64
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period
The number of participants developing binding or neutralizing ADAs during the post-randomization period is defined as the number of participants in the safety analysis set who had a positive result post-randomization and had never tested positive (i.e., negative or no results) prior to the first dose of post-randomization investigational product and who have at least one ADA result post randomization. A transient antibody results was defined as a positive result during the post-randomization period with a negative result at the participant's last visit tested within the respective study period. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.
Measured: Baseline (pre-dose day 1), week 4, week 16, week 28, week 40, week 52 and week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start24 Mar 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761627
- Sponsor's protocol ID
- 20200417
- Other IDs
- 2020-005205-42
- Status last verified
- Jan 2024
- First submitted
- 16 Feb 2021
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded Study Evaluating the Pharmacokinetics, Efficacy and Safety of Multiple Switches Between Ustekinumab and ABP 654 Compared With Continued Use of Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04761627
- Acronym / sponsor ID
- 20200417
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Biosimilar, Psoriasis area and severity index, Ustekinumab, Skin Diseases, Dermatologic Agents, Papulosquamous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 11 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continued-use Group (Ustekinumab) | Active comparator | Drug: UstekinumabParticipants will receive subcutaneous injection of ustekinumab up to Week 52. |
| Switching Group (Ustekinumab - ABP 654) | Experimental | Drug: Ustekinumab, Drug: ABP 654Participants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: Stelara®Participants will receive subcutaneous (SC) injection of ustekinumab. | Drug | Continued-use Group (Ustekinumab), Switching Group (Ustekinumab - ABP 654) |
| ABP 654Participants will receive SC injection of ABP 654. | Drug | Switching Group (Ustekinumab - ABP 654) |
Primary outcome
Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64
Time frame: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
AUCtau from time 0 (week 52) over the dosing interval up to week 64 is presented. Pharmacokinetic (PK) parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.
Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64
Time frame: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Cmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.
8 secondary outcomes
Time of Maximum Serum Concentration (Tmax) Between Week 52 and Week 64
Time frame: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52
Time frame: Blood samples were taken pre-dose week 28, week 40, and week 52
PASI Percent Improvement From Baseline at Week 64
Time frame: Baseline (day 1) and week 64
PASI 75 Response at Week 64
Time frame: Baseline (day 1) and week 64
PASI 100 Response at Week 64
Time frame: Baseline (day 1) and week 64
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Post-randomization Period
Time frame: Week 28 to week 64
Number of Participants With Events of Interest (EOI): Post-randomization Period
Time frame: Week 28 to week 64
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period
Time frame: Baseline (pre-dose day 1), week 4, week 16, week 28, week 40, week 52 and week 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
88 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ustekinumab and ABP 654 in people with Psoriasis, run by Amgen at 88 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, Poland, Canada, Germany, Georgia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64 (time frame: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.