Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003184-25 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A (ABP 654) | Experimental | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP 654 | Drug | Participants will receive SC injection of ABP 654. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PASI Percent Change From Baseline to 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. | Baseline (Day 1 [Week 0]) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| PASI Percent Change at Other Timepoints | 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. |
Not provided
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Stable moderate to severe plaque psoriasis for at least 6 months
Baseline score of PASI >= 12, involvement of >= 10% BSA, and sPGA >= 3 at screening and at baseline
Candidate for phototherapy or systemic therapy
Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
Female participants should have negative serum pregnancy test during screening and a negative urine pregnancy test at baseline
No known history of latent or active tuberculosis (TB), and has a negative test for TB during screening (with negative purified protein derivative (PPD), and Negative Quantiferon®/T-spot test)
Participants with a positive purified protein derivative and a history of Bacillus Calmette-Guérin (BCG) vaccination are allowed with a negative Quantiferon®/T-spot®
Participants with a positive PPD test (without history of BCG vaccination) or participants with a positive or indeterminate Quantiferon®/T-spot test are allowed if they have all of the following:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center PC | Birmingham | Alabama | 35205 | United States | ||
| Alliance Dermatology and Mohs Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39442018 | Derived | Blauvelt A, Papp K, Trivedi M, Barragan C, Chow V, Mytych DT, Yamauchi P, Crowley J, Franklin J. Efficacy and safety of the ustekinumab biosimilar ABP 654 in patients with moderate-to-severe plaque psoriasis: a randomized double-blinded active-controlled comparative clinical study over 52 weeks. Br J Dermatol. 2025 Apr 28;192(5):826-836. doi: 10.1093/bjd/ljae402. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
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.
Of the 648 participants screened, 563 participants were enrolled and randomized in a 1:1 ratio to receive ABP 654 or ustekinumab.
This study was conducted at 84 centers in Canada, Estonia, Germany, Hungary, Latvia, Lithuania, Poland, and the United States between 11 November 2020 and 03 June 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group A (ABP 654) | Participants received SC injection of ABP 654, 45 mg (Baseline body weight [BW] less than or equal to [<=] 100 kg) or 90 mg (Baseline BW greater than [>] 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) every 12 weeks (Q12W) at Weeks 28 and 40 or depending on Psoriasis Area and Severity Index (PASI) score, received dose intensification every 8 weeks (Q8W) at Weeks 28, 36, and 44 (as per protocol). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2020 | Nov 23, 2023 |
Not provided
Not provided
Not provided
Not provided
The Investigators, study personnel with the exception of the clinical research organization's unblinded biostatistician and unblinded programmers; and the data monitoring committee, and the study participants will remain blinded to treatment allocation.
| Ustekinumab | Drug | Participants will receive SC injection of ustekinumab. |
|
|
| 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]) |
| Percentage of Participants With PASI 75 Response Throughout the Study | 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. | 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) |
| Percentage of Participants With PASI 100 Response Throughout the Study | 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. | 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) |
| Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52 | 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. | Week 12 and Week 52 (EOS) |
| Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52 | 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. | Baseline (Day 1 [Week 0]), Week 12 and Week 52 (EOS) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | TEAEs were summarized by actual treatment received. For each category, participants were included only once, even if they experienced multiple events in that category. | Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) |
| Number of Participants With Events of Interests (EOIs) | 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. | Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) |
| Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654 | A participant was considered to have developed ADAs if they:
| Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| University Clinical Trials, Inc. | San Diego | California | 92123 | United States |
| San Luis Dermatology and Laser Clinic - Dermatology | San Luis Obispo | California | 93405 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Unison Clinical Trials | Sherman Oaks | California | 91403 | United States |
| Revival Research | Doral | Florida | 33122 | United States |
| International Dermatology Research, Inc | Miami | Florida | 33144 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Moore Clinical Research Inc. | Tampa | Florida | 33609-2230 | United States |
| NorthShore University HealthSystem | Skokie | Illinois | 60077 | United States |
| Springfield Clinic | Springfield | Illinois | 62703-2403 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250-2041 | United States |
| Epiphany Dermatology of Kansas, LLC | Overland Park | Kansas | 66210 | United States |
| DelRicht Research | Baton Rouge | Louisiana | 70809 | United States |
| ALLCUTIS Research, LLC. | Beverly | Massachusetts | 01915 | United States |
| Metro Boston Clinical Partners | Brighton | Massachusetts | 02135 | 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 |
| Dermatology Consulting Services, PLLC | High Point | North Carolina | 27262 | United States |
| Wilmington Dermatology Center | Wilmington | North Carolina | 28405 | United States |
| Bexley Dermatology Research | Bexley | Ohio | 43209-2421 | United States |
| Dermatologists of Southwest Ohio | Mason | Ohio | 45040 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| The Pennsylvania Centre for Dermatology, LLC | Exton | Pennsylvania | 19341 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| The Skin Wellness Center PC | Knoxville | Tennessee | 37922 | United States |
| Center for Clinical Studies | Cypress | Texas | 77433 | United States |
| Modern Research Associates | Dallas | Texas | 75231 | United States |
| Austin Institute for Clinical Research - Dermatology | Houston | Texas | 77056 | United States |
| Progressive Clinical Research [Texas] | San Antonio | Texas | 78213 | United States |
| Acclaim Dermatology | Sugar Land | Texas | 77479-2645 | United States |
| Beacon Dermatology | Calgary | Alberta | T3E 0B2 | Canada |
| Dr. Chih-ho Hong Medical Inc. | Surrey | British Columbia | V3R 6A7 | Canada |
| CCA Medical Research | Ajax | Ontario | L1S 7K8 | Canada |
| Kingsway Clinical Research | Etobicoke | Ontario | M8X 1Y9 | Canada |
| Dermatrials Research Inc | Hamilton | Ontario | L8N1Y2 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1X3 | Canada |
| DermEdge Research Inc. | Mississauga | Ontario | L4Y 4C5 | Canada |
| North Bay Dermatology Centre Inc. | North Bay | Ontario | P1B 3Z7 | Canada |
| JRB Research Inc. | Ottawa | Ontario | K1H 7X3 | Canada |
| Skin Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| The Centre for Dermatology | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Toronto Research Centre - Dermatology | Toronto | Ontario | M3H 5Y8 | Canada |
| K. Papp Clinical Research Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| XLR8 Medical Research Inc. | Windsor | Ontario | N8W 1E6 | Canada |
| Centre de Recherche dermatolog | Québec | Quebec | G1V 4X7 | Canada |
| Vahlberg & Pild OÜ | Tallinn | Harju | 10134 | Estonia |
| 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 |
| Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling | Mahlow | Brandenburg | 15831 | Germany |
| Derma Zentrum Osnabrueck Nord | Bramsche | Lower Saxony | 49565 | Germany |
| Hautzentrum im Jahrhunderthaus | Bochum | North Rhine-Westphalia | 44793 | Germany |
| CentroDerm GmbH | Wuppertal | North Rhine-Westphalia | 42287 | Germany |
| Brgyógyászati és Allergológiai Magánrendelés | Szolnok | Jász-Nagykun-Szolnok | 5000 | Hungary |
| UNOMEDICALTRIALS Kft | Budapest | Pest County | 1152 | Hungary |
| Health Centre 4 Ltd., Diagnostics Centre | Riga | Rga | LV-1003 | Latvia |
| Riga 1st hospital, Clinic of Dermatology and STD | Riga | Rga | LV1001 | Latvia |
| J.Kisis LtD | Riga | Rga | LV1003 | Latvia |
| Health and Aesthetics Ltd | Riga | LV-1009 | Latvia |
| Smite Aija doctor practice in dermatology, venereology | Talsi | LV3201 | Latvia |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik | Kaunas | Kaunas County | LT-50161 | Lithuania |
| Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras | Vilnius | Vilnius County | LT-08411 | Lithuania |
| Centrum Medyczne ALL-MED | Krakow | Maopolskie | 30-033 | Poland |
| Medycyna Kliniczna | Warsaw | Masovian Voivodeship | 00-874 | Poland |
| ETG Warszawa | Warsaw | Masovian Voivodeship | 02-793 | Poland |
| Royalderm Agnieszka Nawrocka | Warsaw | Masovian Voivodeship | 02-962 | Poland |
| Zespol Naukowo-Leczniczy Iwolang sp. z.o.o. | Iwonicz-Zdrój | Podkarpackie Voivodeship | 38-440 | Poland |
| Specderm Poznanska Sp. j. | Bialystok | Podlaskie Voivodeship | 15-017 | Poland |
| ClinicMed Daniluk, Nowak Sp. J. | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | 40-081 | Poland |
| Centrum Medyczne Angelius Provita | Katowice | 40-611 | Poland |
| Barbara Rewerska Diamond Clinic | Krakow | 31-559 | Poland |
| Centrum Zdrowia i Urody Maxxmed | Lublin | 20-080 | Poland |
| ETG Lublin | Lublin | 20-412 | Poland |
| Solumed | Poznan | 60-529 | Poland |
| Nasz Lekarz Osrodek Badan Klinicznych | Torun | 87-100 | Poland |
| Klinika Ambroziak Dermatologia | Warsaw | 02-953 | Poland |
| DermMedica Sp. z o.o. | Wroclaw | 51-318 | Poland |
| WroMedica I. Bielicka, A. Strzalkowska s.c. | Wroclaw | 51-685 | Poland |
| ETG Skierniewice | Skierniewice | Ódzkie | 96-100 | Poland |
| FG001 | Treatment Group B (Ustekinumab) | Participants received 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 were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol). |
| Treated |
|
| Re-randomized to ABP 654 at Week 28 |
|
| Re-randomized to Ustekinumab at Week 28 |
|
| Not Re-randomized at Week 28 and Dose Intensified |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): consisted of all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group A (ABP 654) | Participants received SC injection of ABP 654, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) Q12W at Weeks 28 and 40 or, depending on PASI score, received dose intensification Q8W at Weeks 28, 36, and 44 (as per protocol). |
| BG001 | Treatment Group B (Ustekinumab) | Participants received 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 were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Static Physician Global Assessment of Psoriasis (sPGA) | 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). | Count of Participants | Participants |
| |||||||||||||||
| PASI | 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. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| Psoriasis Body Surface Area (BSA) | 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. | Mean | Standard Deviation | Percentage of BSA |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PASI Percent Change From Baseline to 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. | Results are presented for the FAS with available data; observed data was used for summary statistics. | Posted | Mean | Standard Deviation | Percent Change in PASI score | Baseline (Day 1 [Week 0]) and Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PASI Percent Change at Other Timepoints | 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. | Through Week 28 results are presented for the FAS with available data; last observation carried forward (LOCF) imputation was used. Post Week 28 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (LOCF imputation was used). | Posted | Mean | Standard Deviation | Percent Change in PASI score | 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]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PASI 75 Response Throughout the Study | 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. | Through Week 28 FAS results are presented for the FAS with available data; non-responder imputation (NRI) was used. Post Week 28 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (NRI was used). | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PASI 100 Response Throughout the Study | 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. | Through Week 28 FAS results are presented for the FAS with available data; NRI was used. Post Week 28 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (NRI was used). | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52 | 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. | Week 12 results are presented for the FAS with available data; NRI was used. Week 52 results are presented for dose intensification participants with available data and re-randomized FAS participants with available data (NRI was used). | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 and Week 52 (EOS) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52 | 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. | Week 12 results are presented for the FAS with available data; LOCF imputation was used. Week 52 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (LOCF imputation was used). | Posted | Mean | Standard Deviation | Percentage of BSA | Baseline (Day 1 [Week 0]), Week 12 and Week 52 (EOS) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | TEAEs were summarized by actual treatment received. For each category, participants were included only once, even if they experienced multiple events in that category. | Through Week 28 results are presented for the Safety Analysis Set. Post Week 28 results are presented for the re-randomized Safety Analysis Set and the dose intensification participants. | Posted | Count of Participants | Participants | Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Events of Interests (EOIs) | 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. | Through Week 28 results are presented for the Safety Analysis Set. Post Week 28 results are presented for the re-randomized Safety Analysis Set. | Posted | Count of Participants | Participants | Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654 | A participant was considered to have developed ADAs if they:
| Through Week 28 results are presented for the Safety Analysis Set with available ADA data. Post Week 28 results are presented for the re-randomized Safety Analysis Set and dose intensification participants with available ADA data. | Posted | Count of Participants | Participants | Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS) |
|
Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
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 | Through Week 28: ABP 654 | All participants who were randomized to receive SC injection of ABP 654, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16. | 0 | 280 | 7 | 280 | 21 | 280 |
| EG001 | Through Week 28: Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16. | 1 | 282 | 5 | 282 | 15 | 282 |
| EG002 | Post Week 28: ABP 654 / ABP 654 | All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40. | 0 | 247 | 1 | 247 | 36 | 247 |
| EG003 | Post Week 28: Ustekinumab / ABP654 | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. | 0 | 117 | 1 | 117 | 22 | 117 |
| EG004 | Post Week 28: Ustekinumab / Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40. | 0 | 116 | 3 | 116 | 17 | 116 |
| EG005 | Post Week 28: ABP 654 Dose Intensification | All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44. | 0 | 25 | 1 | 25 | 9 | 25 |
| EG006 | Post Week 28: Ustekinumab Dose Intensification | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44. | 0 | 34 | 0 | 34 | 2 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
Due to non-convergence of the generalized linear model used for pre-specified analyses, ad hoc analyses were conducted for efficacy endpoints of PASI 75 response, PASI 100 response, and sPGA response.
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. | 8665726436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2020 | Nov 23, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| 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
| Preterm newborn infants (gestational age < 37 wks) |
|
| Newborns (0-27 days) |
|
| Infants and toddlers (28 days-23 months) |
|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Adults (18-64 years) |
|
| From 65-84 years |
|
| 85 years and over |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or other Pacific Islander |
|
| White |
|
| Multiple |
|
| Not allowed to collect |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not allowed to collect |
|
| Unknown |
|
| Score 1 (almost clear) |
|
| Score 2 (mild) |
|
| Score 3 (moderate) |
|
| Score 4 (severe) |
|
| Score 5 (very severe) |
|
| OG002 | Post Week 28: ABP 654/ ABP 654 | All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40. |
| OG003 | Post Week 28: Ustekinumab/ ABP 654 | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. |
| OG004 | Post Week 28: Ustekinumab/ Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40. |
|
|
|
Participants received 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 were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol). |
| OG002 | Post Week 28: ABP 654/ ABP 654 | All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40. |
| OG003 | Post Week 28: Ustekinumab/ ABP 654 | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. |
| OG004 | Post Week 28: Ustekinumab/ Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40. |
|
|
|
Participants received 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 were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol). |
| OG002 | Post Week 28: ABP 654/ ABP 654 | All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40. |
| OG003 | Post Week 28: Ustekinumab/ ABP 654 | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. |
| OG004 | Post Week 28: Ustekinumab/ Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40. |
|
|
|
| OG002 | Post Week 28: ABP 654/ ABP 654 | All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40. |
| OG003 | Post Week 28: Ustekinumab/ ABP 654 | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. |
| OG004 | Post Week 28: Ustekinumab/ Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40. |
|
|
|
| OG002 | Post Week 28: ABP 654/ ABP 654 | All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40. |
| OG003 | Post Week 28: Ustekinumab/ ABP 654 | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. |
| OG004 | Post Week 28: Ustekinumab/ Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40. |
|
|
|
| OG003 |
| Post Week 28: Ustekinumab/ ABP 654 |
All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. |
| OG004 | Post Week 28: Ustekinumab/ Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40. |
| OG005 | Post Week 28: ABP 654 Dose Intensification | All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44. |
| OG006 | Post Week 28: Ustekinumab Dose Intensification | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44. |
|
|
| OG003 | Post Week 28: Ustekinumab/ ABP 654 | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. |
| OG004 | Post Week 28: Ustekinumab/ Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40. |
|
|
All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.
| OG003 | Post Week 28: Ustekinumab/ ABP 654 | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. |
| OG004 | Post Week 28: Ustekinumab/ Ustekinumab | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40. |
| OG005 | Post Week 28: ABP 654 Dose Intensification | All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44. |
| OG006 | Post Week 28: Ustekinumab Dose Intensification | All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|