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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500408-22-00 | Other Identifier | EU CT |
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Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study M19-977.
Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the pediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide.
Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Experimental | Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Subcutaneous (SC) injection. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. | Up to approximately 224 weeks |
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Inclusion Criteria:
--Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.
Exclusion Criteria:
--Participants who have developed any discontinuation criteria as defined in Study M19-977.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Department of Dermatology /ID# 252305 | Birmingham | Alabama | 35233 | United States | ||
| First OC Dermatology /ID# 226942 |
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| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Fountain Valley |
| California |
| 92708 |
| United States |
| Integrative Skin Science and Research /ID# 226108 | Sacramento | California | 95815 | United States |
| University of California San Diego - Rady Children's Hospital San Diego /ID# 252348 | San Diego | California | 92123 | United States |
| Solutions Through Adv Rch /ID# 226104 | Jacksonville | Florida | 32256 | United States |
| Olympian Clinical Research- St. Petersburg /ID# 226106 | St. Petersburg | Florida | 33709-1405 | United States |
| Advanced Clinical Research Institute /ID# 248827 | Tampa | Florida | 33607 | United States |
| University Dermatology and Vein Clinic, LLC /ID# 226100 | Darien | Illinois | 60561 | United States |
| Arlington Dermatology /ID# 226097 | Rolling Meadows | Illinois | 60008 | United States |
| Skin Cancer and Dermatology Institute - Reno /ID# 248828 | Reno | Nevada | 89509 | United States |
| Univ Hosp Cleveland /ID# 248825 | Cleveland | Ohio | 44106 | United States |
| Apex Clinical Research Center /ID# 248830 | Mayfield Heights | Ohio | 44124 | United States |
| Medical University of South Carolina /ID# 248831 | Charleston | South Carolina | 29425 | United States |
| West Virginia University Hospitals /ID# 263438 | Morgantown | West Virginia | 26506 | United States |
| Wisconsin Medical Center /ID# 263437 | Milwaukee | Wisconsin | 53226 | United States |
| Karma Clinical Trials /ID# 233985 | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| Hospital for Sick Children /ID# 233986 | Toronto | Ontario | M5G 1X8 | Canada |
| Fachklinik Bad Bentheim /ID# 243904 | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Universitaetsklinikum Bonn /ID# 243910 | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Universitaetsklinikum Muenster /ID# 243905 | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitaetsmedizin Mainz /ID# 243907 | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden /ID# 243908 | Dresden | Saxony | 01307 | Germany |
| Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883 | Kiel | Schleswig-Holstein | 24105 | Germany |
| Nagoya City University Hospital /ID# 248429 | Nagoya | Aichi-ken | 467-8602 | Japan |
| Mie University Hospital /ID# 263008 | Tsu | Mie-ken | 514-8507 | Japan |
| Kansai Medical University Hirakata Hospital /ID# 252332 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Tokyo Medical University Hospital /ID# 252331 | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| High-Med Przychodnia Specjalistyczna /ID# 243846 | Warsaw | Masovian Voivodeship | 01-817 | Poland |
| Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 243850 | Rzeszów | Podkarpackie Voivodeship | 35-055 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849 | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Dermed Centrum Medyczne Sp. z o.o /ID# 243847 | Lodz | Łódź Voivodeship | 90-265 | Poland |
| Dermoklinika Medical Center /ID# 243848 | Lodz | Łódź Voivodeship | 90-436 | Poland |
| Hospital Sant Joan de Deu /ID# 241103 | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 241099 | Madrid | 28007 | Spain |
| Hospital Universitario Infanta Leonor /ID# 241100 | Madrid | 28031 | Spain |
| Hospital Universitario 12 de Octubre /ID# 241102 | Madrid | 28041 | Spain |
| Complejo Hospitalario Universitario de Pontevedra /ID# 241101 | Pontevedra | 36071 | Spain |
| Royal Devon & Exeter Hospital /ID# 245101 | Exeter | Devon | EX2 5DW | United Kingdom |
| Derriford Hospital and the Royal Eye Infirmary /ID# 245104 | Plymouth | Devon | PL6 8DH | United Kingdom |
| Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 245100 | London | Greater London | SE1 9RT | United Kingdom |
| Chelsea and Westminster Hospital /ID# 245102 | London | Greater London | SW10 9NH | United Kingdom |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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