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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005205-42 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continued-use Group (Ustekinumab) | Active Comparator | Participants will receive subcutaneous injection of ustekinumab up to Week 52. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | Participants will receive subcutaneous (SC) injection of ustekinumab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Zenith Research Inc. |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Participants with moderate to severe plaque psoriasis were randomized at week 28 to 1 of 2 treatment groups following a run-in period. Randomization was stratified by prior biologic use for psoriasis at baseline, geographic region, and body weight group at baseline. Dosage was weight-based to ensure similar concentration by body weight received.
Participants were enrolled at 87 study centers in 8 countries, including Canada, Estonia, Georgia, Germany, Hungary, Latvia, Poland, and the United States, and participated from 24 March 2021 to 28 February 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Run-in: Ustekinumab Reference Product (RP) | Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) on day 1 (week 0), week 4, and week 16. At week 28, eligible participants with a 50% improvement in Psoriasis Area and Severity Index (PASI 50) response or better were randomized to the continued use group (ustekinumab RP) or the switching group (ustekinumab RP and ABP 654). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-in Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2021 | Jan 10, 2024 |
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The investigators, study personnel (with the exception of the Data Monitoring Committee (DMC), and unblinded Parexel staff supporting DMC activities and randomization list activities) and the study participants will remain blinded to treatment allocation. ABP 654 and ustekinumab will be coded and labeled in a manner that protects blinding.
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| ABP 654 | Drug | Participants will receive SC injection of ABP 654. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline (pre-dose day 1), week 4, week 16, week 28, week 40, week 52 and week 64 |
| Beverly Hills |
| California |
| 90212 |
| United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Quest Dermatology Research | Northridge | California | 91324-4669 | 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 | 33028-1013 | 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 0C6 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Dr. Irina Turchin PC Inc. | Fredericton | New Brunswick | E3B 1G9 | Canada |
| CCA Medical Research | Ajax | Ontario | L1S 7K8 | Canada |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M 7G1 | Canada |
| Guelph Dermatology Research | Guelph | Ontario | N1L 0B7 | Canada |
| Dr Wei Jing Loo Medicine Professional Corporation | London | Ontario | N6H 5L5 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1X3 | Canada |
| DermEdge Research Inc. | Mississauga | Ontario | L4Y 4C5 | Canada |
| Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office | Newmarket | Ontario | L3Y 5G8 | Canada |
| North York Research Inc. - Dermatology | North York | Ontario | M2M 4J5 | Canada |
| Dermatology Ottawa Research Centre | Ottawa | Ontario | K2C 3N2 | Canada |
| Research Toronto | Toronto | Ontario | M4W 2N4 | Canada |
| K. Papp Clinical Research Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| Confido Private Medical Clinic - General Practice/Medicine | Tallinn | Harju | 10138 | Estonia |
| Clinical Research Center | Tartu | Tartu | 50106 | Estonia |
| Tartu University Hospital | Tartu | Tartu | 50417 | Estonia |
| Innomedica OÜ | Tallinn | 10117 | Estonia |
| Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine | Tbilisi | K'alak'i T'bilisi | 0112 | Georgia |
| LTD Israeli-Georgian Medical Research Clinic Helsicore | Tbilisi | K'alak'i T'bilisi | 0112 | Georgia |
| ,,Tbilisi Cancer center"LTD | Tbilisi | K'alak'i T'bilisi | 0159 | Georgia |
| LTD Aversi Clinic | Tbilisi | K'alak'i T'bilisi | 0160 | Georgia |
| ,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC | Tbilisi | 0159 | Georgia |
| Derma-Study-Center-FN | Friedrichshafen | Baden-Wurttemberg | 88045 | Germany |
| Dermazentrum Augsburg | Augsburg | Bavaria | 86179 | Germany |
| Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling | Mahlow | Brandenburg | 15831 | Germany |
| Universitätsklinikum Frankfurt am Main - Klinik für Dermatol | Frankfurt am Main | Hesse | 60590 | Germany |
| Fachklinik Bad Bentheim | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Praxis Hoffmann | Witten | North Rhine-Westphalia | 58453 | Germany |
| Klinische Forschung Dresden GmbH | Dresden | Saxony | 01069 | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | Saxony | 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 County | 1036 | Hungary |
| UNOMEDICALTRIALS Kft | Budapest | Pest County | 1152 | Hungary |
| Riga 1st hospital, Clinic of Dermatology and STD | Riga | Rga | LV1001 | Latvia |
| J.Kisis LtD | Riga | Rga | LV1003 | Latvia |
| Smite Aija doctor practice in dermatology, venereology | Talsi | LV3201 | Latvia |
| Centrum Medyczne ALL-MED Badania Kliniczne | Krakow | Maopolskie | 30-033 | Poland |
| Centrum Medyczne Plejady | Krakow | Maopolskie | 30-363 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | Masovian Voivodeship | 00-874 | Poland |
| RENEW CLINIC Spolka Jawna | Bialystok | 15-794 | Poland |
| MICS Centrum Medyczne Bydgoszcz | Bydgoszcz | 85-065 | Poland |
| Centrum Medyczne Pratia Bydgoszcz | Bydgoszcz | 85-796 | Poland |
| Centrum Medyczne Pratia Gdynia | Gdynia | 81-338 | Poland |
| Krakowskie Centrum Medyczne Sp. z o.o. | Krakow | 31-501 | Poland |
| Centrum Medyczne PROMED | Krakow | 31-513 | Poland |
| Barbara Rewerska Diamond Clinic | Krakow | 31-559 | Poland |
| ETG Siedlce | Siedlce | 08-110 | Poland |
| RCMed Oddzial Sochaczew | Sochaczew | 96-500 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| RCMed Oddzia Warszawa | Warsaw | 00-892 | Poland |
| Centrum Medyczne Evimed | Warsaw | 02-625 | Poland |
| DermMedica Sp. z o.o. | Wroclaw | 51-318 | Poland |
| FG001 | Post-randomization Switching: Ustekinumab RP and ABP 654 | At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg [baseline body weight ≤ 100 kg] or 90 mg [baseline body weight > 100 kg]) were administered by SC injection using a pre-filled syringe. |
| FG002 | Post-randomization Continued-use: Ustekinumab RP | At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe. |
| COMPLETED |
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| NOT COMPLETED |
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| Post-randomization Period |
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Baseline characteristics are presented for the full analysis set which included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Post-randomization Switching: Ustekinumab RP and ABP 654 | At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg [baseline body weight ≤ 100 kg] or 90 mg [baseline body weight > 100 kg]) were administered by SC injection using a pre-filled syringe. |
| BG001 | Post-randomization Continued-use: Ustekinumab RP | At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | The PK parameter analysis set consisted of all randomized participants who received all 3 doses of the assigned investigational product between week 28 and week 52 and who had an evaluable ABP 654 or ustekinumab serum concentration-time profile between week 52 and week 64. Participants with data available are presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*mcg/mL | 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 |
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| Primary | 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. | The PK parameter analysis set consisted of all randomized participants who received all 3 doses of the assigned investigational product between week 28 and week 52 and who had an evaluable ABP 654 or ustekinumab serum concentration-time profile between week 52 and week 64. Participants with data available are presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 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 |
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| Secondary | 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. | The PK parameter analysis set consisted of all randomized participants who received all 3 doses of the assigned investigational product between week 28 and week 52 and who had an evaluable ABP 654 or ustekinumab serum concentration-time profile between week 52 and week 64. Participants with data available are presented. | Posted | Median | Full Range | hours | 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 |
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| Secondary | 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. | The PK parameter analysis set consisted of all randomized participants who received all 3 doses of the assigned investigational product between week 28 and week 52 and who had an evaluable ABP 654 or ustekinumab serum concentration-time profile between week 52 and week 64. Participants with data available at each time point are presented and all participants in the overall number of participants analyzed contributed to the data in the endpoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Blood samples were taken pre-dose week 28, week 40, and week 52 |
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| Secondary | 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. | The per-protocol efficacy analysis set included all participants who were randomized and received all 3 doses of the assigned interventional product between week 28 and week 52 and who did not experience an important protocol deviation during the study that could affect the evaluation of the efficacy endpoints. The overall number of participants analyzed includes those imputed by MI as well as those with observed data. | Posted | Mean | Standard Deviation | Percentage change | Baseline (day 1) and week 64 |
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| Secondary | 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. | The per-protocol efficacy analysis set included all participants who were randomized and received all 3 doses of the assigned interventional product between week 28 and week 52 and who did not experience an important protocol deviation during the study that could affect the evaluation of the efficacy endpoints. The overall number of participants analyzed includes those imputed by NRI as well as those with observed data. | Posted | Number | 95% Confidence Interval | Percentage of responders | Baseline (day 1) and week 64 |
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| Secondary | 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. | The per-protocol efficacy analysis set included all participants who were randomized and received all 3 doses of the assigned interventional product between week 28 and week 52 and who did not experience an important protocol deviation during the study that could affect the evaluation of the efficacy endpoints. The overall number of participants analyzed includes those imputed by NRI as well as those with observed data. | Posted | Number | 95% Confidence Interval | Percentage of responders | Baseline (day 1) and week 64 |
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| Secondary | 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. | The safety analysis set included all randomized participants who received at least 1 dose of investigational product post randomization. | Posted | Count of Participants | Participants | Week 28 to week 64 |
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| Secondary | 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. | Participants in the safety analysis set who completed all planned doses of investigational product in the post-randomization period up to week 52. The safety analysis set included all randomized participants who received at least 1 dose of investigational product post randomization. | Posted | Count of Participants | Participants | Week 28 to week 64 |
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| Secondary | 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. | The safety analysis set included all randomized participants who received at least 1 dose of investigational product post randomization. | Posted | Count of Participants | Participants | Baseline (pre-dose day 1), week 4, week 16, week 28, week 40, week 52 and week 64 |
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All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in: Ustekinumab RP | Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) on day 1 (week 0), week 4, and week 16. | 2 | 494 | 14 | 494 | 116 | 494 |
| EG001 | Post-randomization Switching: Ustekinumab RP and ABP 654 | Participants were randomized to the switching group at week 28 and completed all planned doses of ABP 654 and ustekinumab RP up to week 52, including ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. | 0 | 217 | 3 | 217 | 55 | 217 |
| EG002 | Post-randomization Continued-use: Ustekinumab RP | Participants were randomized to the continued-use group at week 28 and completed all planned doses of ustekinumab RP up to week 52, including 3 doses at weeks 28, 40, and 52. | 0 | 216 | 2 | 216 | 58 | 216 |
| EG003 | Post-randomization Switching: ABP 654/Ustekinumab RP/Missing | Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG004 | Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing | Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG005 | Post-randomization Switching: ABP 654/Missing/Missing | Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG006 | Post-randomization Continued-use: Ustekinumab RP/Missing/Missing | Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52. | 0 | 3 | 0 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Facial paralysis | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dermatillomania | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Erythrodermic psoriasis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal wall wound | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Brain neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Scleroedema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2023 | Jan 10, 2024 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Pregnancy |
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| Study site closure |
|
| Family planning |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Black or African American |
|
| Other |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Not allowed to collect |
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| OG001 | Post-randomization Continued-use: Ustekinumab RP | At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe. |
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| OG001 | Post-randomization Continued-use: Ustekinumab RP | At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe. |
|
|
|
| OG001 | Post-randomization Continued-use: Ustekinumab RP | At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe. |
|
|
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| OG002 | Post-randomization Switching: ABP 654/Ustekinumab RP/Missing | Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52. |
| OG003 | Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing | Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52. |
| OG004 | Post-randomization Switching: ABP 654/Missing/Missing | Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52. |
| OG005 | Post-randomization Continued-use: Ustekinumab RP/Missing/Missing | Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52. |
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| OG002 | Post-randomization Switching: ABP 654/Ustekinumab RP/Missing | Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52. |
| OG003 | Post-randomization Continued-use: Ustekinumab RP/Ustekinumab RP/Missing | Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52. |
| OG004 | Post-randomization Switching: ABP 654/Missing/Missing | Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52. |
| OG005 | Post-randomization Continued-use: Ustekinumab RP/Missing/Missing | Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52. |
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