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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511738-11 | Registry Identifier | EU Clinical Trials | |
| U1111-1306-6697 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab | Experimental | Study participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period. |
|
| Risankizumab | Active Comparator | Study participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Study participants will receive bimekizumab at pre-specified time points. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology 50 (ACR50) at Week 16 | The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
| Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Disease Activity (MDA) at Week 16 | A study participant is considered as having MDA if 5 or more of the following 7 criteria are fulfilled:
| Week 16 |
| Percentage of participants reaching the composite endpoint composed of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 in the subgroup of study participants with PSO involving at least 3% body surface area (BSA) at Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pa0016 50662 | Gilbert | Arizona | 85297 | United States | ||
| Pa0016 50062 |
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
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| Risankizumab |
| Drug |
Study participants will receive risankizumab at pre-specified time points. |
|
| Placebo | Drug | Study participants will receive placebo at pre-specified time points. |
|
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline. The PASI100 response is based on at least 100% improvement in the PASI score. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Week 16 |
| American College of Rheumatology 50 (ACR50) at Week 4 | The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
| Week 4 |
| Incidence of Participants With Treatment-emergent adverse events (TEAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. | From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks) |
| Incidence of Participants With Treatment-emergent serious AEs | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
| From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks) |
| Incidence of Participants With TEAEs leading to withdrawal from investigational medicinal product (IMP) | An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. | From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks) |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Pa0016 50058 | Phoenix | Arizona | 85032 | United States |
| Pa0016 50131 | Sun City | Arizona | 85351 | United States |
| Pa0016 50654 | Covina | California | 91722 | United States |
| Pa0016 50663 | San Diego | California | 92128 | United States |
| Pa0016 50672 | Santa Monica | California | 90404 | United States |
| Pa0016 50630 | Clearwater | Florida | 33765 | United States |
| Pa0016 50679 | Cutler Bay | Florida | 33189 | United States |
| Pa0016 50685 | Fort Lauderdale | Florida | 33309 | United States |
| Pa0016 50059 | Ormond Beach | Florida | 32174 | United States |
| Pa0016 50324 | Plantation | Florida | 33324 | United States |
| Pa0016 50678 | Zephyrhills | Florida | 33542 | United States |
| Pa0016 50651 | Skokie | Illinois | 60076 | United States |
| Pa0016 50650 | Willowbrook | Illinois | 60527 | United States |
| Pa0016 50686 | Hagerstown | Maryland | 21740 | United States |
| Pa0016 50665 | Lansing | Michigan | 48910 | United States |
| Pa0016 50551 | Saint Clair Shores | Michigan | 48081 | United States |
| Pa0016 50689 | Eagan | Minnesota | 55123 | United States |
| Pa0016 50682 | Kansas City | Missouri | 64111 | United States |
| Pa0016 50016 | St Louis | Missouri | 63141 | United States |
| Pa0016 50653 | Albuquerque | New Mexico | 87102 | United States |
| Pa0016 50666 | Brooklyn | New York | 11201 | United States |
| Pa0016 50664 | Middletown | Ohio | 45044 | United States |
| Pa0016 50680 | Vandalia | Ohio | 45377 | United States |
| Pa0016 50652 | Duncansville | Pennsylvania | 16635 | United States |
| Pa0016 50006 | Wyomissing | Pennsylvania | 19610 | United States |
| Pa0016 50001 | Jackson | Tennessee | 38305 | United States |
| Pa0016 50673 | Fort Worth | Texas | 76109 | United States |
| Pa0016 50048 | Katy | Texas | 77449 | United States |
| Pa0016 50657 | Lubbock | Texas | 79424 | United States |
| Pa0016 50655 | Tomball | Texas | 77375 | United States |
| Pa0016 50061 | Spokane Valley | Washington | 99216 | United States |
| Pa0016 50674 | Glendale | Wisconsin | 53217 | United States |
| Pa0016 30002 | Clayton | Australia |
| Pa0016 30034 | Footscray | Australia |
| Pa0016 30033 | Heidelberg | Australia |
| Pa0016 30003 | Maroochydore | Australia |
| Pa0016 30032 | Parramatta | Australia |
| Pa0016 30009 | Westmead | Australia |
| Pa0016 40313 | Pleven | Bulgaria |
| Pa0016 40006 | Plovdiv | Bulgaria |
| Pa0016 40813 | Plovdiv | Bulgaria |
| Pa0016 40818 | Plovdiv | Bulgaria |
| Pa0016 40820 | Plovdiv | Bulgaria |
| Pa0016 40656 | Rousse | Bulgaria |
| Pa0016 40823 | Rousse | Bulgaria |
| Pa0016 40314 | Sofia | Bulgaria |
| Pa0016 40380 | Sofia | Bulgaria |
| Pa0016 40811 | Sofia | Bulgaria |
| Pa0016 40819 | Sofia | Bulgaria |
| Pa0016 50041 | Québec | Canada |
| Pa0016 50044 | Trois-Rivières | Canada |
| Pa0016 40065 | Brno | Czechia |
| Pa0016 40062 | Moravska Ostrava A Privoz | Czechia |
| Pa0016 40802 | Ostrava | Czechia |
| Pa0016 40066 | Prague | Czechia |
| Pa0016 40801 | Prague | Czechia |
| Pa0016 40010 | Uherské Hradiště | Czechia |
| Pa0016 40012 | Zlín | Czechia |
| Pa0016 40073 | Bad Nauheim | Germany |
| Pa0016 40025 | Berlin | Germany |
| Pa0016 40138 | Bonn | Germany |
| Pa0016 40808 | Cologne | Germany |
| Pa0016 40072 | Freiburg im Breisgau | Germany |
| Pa0016 40029 | Hamburg | Germany |
| Pa0016 40810 | Herne | Germany |
| Pa0016 40724 | München | Germany |
| Pa0016 40800 | Ratingen | Germany |
| Pa0016 40081 | Budapest | Hungary |
| Pa0016 40804 | Budapest | Hungary |
| Pa0016 40809 | Hódmezővásárhely | Hungary |
| Pa0016 40031 | Szeged | Hungary |
| Pa0016 20035 | Bunkyō City | Japan |
| Pa0016 20043 | Itabashi-ku | Japan |
| Pa0016 20045 | Kita-gun | Japan |
| Pa0016 20049 | Kitakyushu | Japan |
| Pa0016 20069 | Meguro-ku | Japan |
| Pa0016 20336 | Mitaka-shi | Japan |
| Pa0016 20041 | Osaka | Japan |
| Pa0016 20046 | Osaka | Japan |
| Pa0016 20031 | Sapporo | Japan |
| Pa0016 40789 | Bialystok | Poland |
| Pa0016 40791 | Bialystok | Poland |
| Pa0016 40824 | Bialystok | Poland |
| Pa0016 40119 | Bydgoszcz | Poland |
| Pa0016 40798 | Bydgoszcz | Poland |
| Pa0016 40038 | Elblag | Poland |
| Pa0016 40795 | Katowice | Poland |
| Pa0016 40092 | Krakow | Poland |
| Pa0016 40490 | Krakow | Poland |
| Pa0016 40502 | Krakow | Poland |
| Pa0016 40792 | Krakow | Poland |
| Pa0016 40037 | Lublin | Poland |
| Pa0016 40483 | Nadarzyn | Poland |
| Pa0016 40091 | Nowa Sól | Poland |
| Pa0016 40796 | Olsztyn | Poland |
| Pa0016 40794 | Opole | Poland |
| Pa0016 40044 | Poznan | Poland |
| Pa0016 40090 | Poznan | Poland |
| Pa0016 40807 | Poznan | Poland |
| Pa0016 40790 | Sochaczew | Poland |
| Pa0016 40788 | Torun | Poland |
| Pa0016 40094 | Warsaw | Poland |
| Pa0016 40394 | Warsaw | Poland |
| Pa0016 40539 | Warsaw | Poland |
| Pa0016 40604 | Warsaw | Poland |
| Pa0016 40793 | Warsaw | Poland |
| Pa0016 40797 | Warsaw | Poland |
| Pa0016 40043 | Wroclaw | Poland |
| Pa0016 40095 | Wroclaw | Poland |
| Pa0016 40805 | Wroclaw | Poland |
| Pa0016 40806 | A Coruña | Spain |
| Pa0016 40269 | Bilbao | Spain |
| Pa0016 40231 | Madrid | Spain |
| Pa0016 40102 | Málaga | Spain |
| Pa0016 40803 | Sabadell | Spain |
| Pa0016 40753 | Santiago de Compostela | Spain |
| Pa0016 40049 | Seville | Spain |
| Pa0016 40799 | Seville | Spain |
| Pa0016 40833 | Barnet | United Kingdom |
| Pa0016 40281 | Leeds | United Kingdom |
| Pa0016 40827 | Luton | United Kingdom |
| Pa0016 40237 | Manchester | United Kingdom |
| Pa0016 40306 | Newcastle upon Tyne | United Kingdom |
| Pa0016 40828 | Reading | United Kingdom |
| Pa0016 40108 | Salford | United Kingdom |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
| C000601773 | risankizumab |
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