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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004932-12 | EudraCT Number |
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The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Experimental | Participants randomized to risankizumab receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France). |
|
| Secukinumab | Active Comparator | Participants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risankizumab | Drug | Subcutaneous (SC) injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data. | Week 16 |
| Percentage of Participants With a PASI 90 at Week 52 | The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Associates - Glendale /ID# 204335 | Glendale | Arizona | 85308 | United States | ||
| Alliance Dermatology and MOHs /ID# 204336 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35050485 | Derived | Crowley JJ, Langley RG, Gordon KB, Pinter A, Ferris LK, Rubant S, Photowala H, Xue Z, Wu T, Zhan T, Beeck S, Shah M, Warren RB. Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study. Dermatol Ther (Heidelb). 2022 Feb;12(2):561-575. doi: 10.1007/s13555-021-00679-6. Epub 2022 Jan 20. |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Eligible participants were randomized to receive risankizumab or secukinumab in a 1:1 ratio. The randomization was stratified by weight (≤ 100 kg vs. > 100 kg) and prior systemic biologic for psoriasis (0 vs. ≥ 1).
A total of 327 participants were randomized from 53 sites across 9 countries including Canada, France, Germany, Italy, The Netherlands, Poland, Spain, the United Kingdom, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab | Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48. |
| FG001 | Risankizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 16, 2019 | Jun 21, 2021 |
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| secukinumab | Drug | Subcutaneous (SC) injection |
|
|
| Week 52 |
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all 3; Almost clear (1) = mean > 0, < 1.5; Mild (2) = mean ≥ 1.5, < 2.5; Moderate (3) = mean ≥ 2.5, < 3.5; and Severe (4) = mean ≥ 3.5. | Week 52 |
| Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52 | The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Week 52 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Bakersfield Derma & Skin Cance /ID# 202115 | Bakersfield | California | 93309 | United States |
| Center for Dermatology Clin Res /ID# 202116 | Fremont | California | 94538 | United States |
| Dermatology Res. Assoc., CA /ID# 202170 | Los Angeles | California | 90045 | United States |
| UC Davis Health /ID# 202263 | Sacramento | California | 95816 | United States |
| Medderm Associates /ID# 202162 | San Diego | California | 92103 | United States |
| UConn Health Main /ID# 201745 | Farmington | Connecticut | 06032 | United States |
| Tory P Sullivan, MD PA /ID# 202177 | North Miami Beach | Florida | 33162-4708 | United States |
| Renstar Medical Research /ID# 202113 | Ocala | Florida | 34470 | United States |
| Progressive Medical Research /ID# 202183 | Port Orange | Florida | 32127 | United States |
| Integrated Clinical Research LLC /ID# 202152 | West Palm Beach | Florida | 33406-6063 | United States |
| Dermatology Specialists Resear /ID# 202145 | Louisville | Kentucky | 40241 | United States |
| Dermatology and Skin Cancer Specialists, LLC /ID# 203938 | Rockville | Maryland | 20850 | United States |
| ORA, Inc. /ID# 204342 | Andover | Massachusetts | 01810 | United States |
| Beth Israel Deaconess Medical Center /ID# 204340 | Boston | Massachusetts | 02215-5400 | United States |
| Minnesota Clinical Study Center /ID# 202369 | New Brighton | Minnesota | 55112 | United States |
| Central Dermatology, PC /ID# 202156 | St Louis | Missouri | 63117 | United States |
| Psoriasis Treatment Ctr of Central NJ /ID# 202107 | East Windsor | New Jersey | 08520 | United States |
| Synexus Research Cincinnati /ID# 202161 | Cincinnati | Ohio | 45236 | United States |
| Oregon Derm & Res. Ctr /ID# 201652 | Portland | Oregon | 97210 | United States |
| Oregon Medical Res Center PC /ID# 201651 | Portland | Oregon | 97223 | United States |
| Clinical Partners, LLC /ID# 201736 | Johnston | Rhode Island | 02919 | United States |
| Center for Clinical Studies - Houston (Binz) /ID# 202178 | Houston | Texas | 77004-8097 | United States |
| Progressive Clinical Research /ID# 202155 | San Antonio | Texas | 78229 | United States |
| Center for Clinical Studies - Webster TX /ID# 202154 | Webster | Texas | 77598 | United States |
| University of Utah /ID# 204035 | Salt Lake City | Utah | 84112-5500 | United States |
| Froedtert Mem Lutheran Hosp /ID# 204896 | Milwaukee | Wisconsin | 53226 | United States |
| Beacon Dermatology Inc /ID# 203054 | Calgary | Alberta | T3E 0B2 | Canada |
| Enverus Medical Research /ID# 203043 | Surrey | British Columbia | V3V 0C6 | Canada |
| Dr. Irina Turchin PC Inc. /ID# 203052 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Eastern Canada Cutaneous Resea /ID# 203045 | Halifax | Nova Scotia | B3H 1Z2 | Canada |
| Dermatrials Research /ID# 203051 | Hamilton | Ontario | L8N 1Y2 | Canada |
| Dre Angelique Gagne-Henley M.D. inc. /ID# 203053 | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| Dermatologique du Quebec /ID# 203050 | Québec | G1V 4X7 | Canada |
| Charles Nicolle CHU Rouen /ID# 203590 | Rouen | Seine-Maritime | 76031 | France |
| Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591 | Nice | 06202 | France |
| Hopital Saint-Louis /ID# 203586 | Paris | 75010 | France |
| Polyclinique Courlancy /ID# 203588 | Reims | 51100 | France |
| Hopital Larrey - CHU de Toulouse /ID# 203587 | Toulouse | 31059 | France |
| TU Uniklinik Munchen /ID# 203919 | Munich | 80802 | Germany |
| Policlinico A. Gemelli /ID# 203009 | Rome | Lazio | 00168 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982 | Milan | Lombardy | 20122 | Italy |
| Radboud Universitair Medisch Centrum /ID# 202560 | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Bravis Ziekenhuis /ID# 205232 | Bergen op Zoom | North Brabant | 4624 VT | Netherlands |
| Academisch Medical center Amsterdam /ID# 202556 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Klinika Dermatologii Pod Fortem /ID# 204180 | Krakow | Lesser Poland Voivodeship | 31-302 | Poland |
| Przychodnia Specjalistyczna High-Med /ID# 203183 | Warsaw | Masovian Voivodeship | 01-817 | Poland |
| Klinika Ambroziak Sp. z o.o. /ID# 203928 | Warsaw | Masovian Voivodeship | 02-758 | Poland |
| KSW nr1 w Rzeszowie /ID# 203776 | Rzeszów | Podkarpackie Voivodeship | 35-055 | Poland |
| Osteo-Medic S.C. /ID# 203742 | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| Dermed Centrum Medyczne Sp. z o.o /ID# 203171 | Lodz | Łódź Voivodeship | 90-265 | Poland |
| Hospital de Manises /ID# 203757 | Manises | Valencia | 46940 | Spain |
| Hospital General Universitario Alicante /ID# 203764 | Alicante | 03010 | Spain |
| Hospital Universitario Clinico San Cecilio /ID# 203760 | Granada | 18016 | Spain |
| Hospital Universitario de la Princesa /ID# 203754 | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre /ID# 203756 | Madrid | 28041 | Spain |
| Hospital Universitario Arnau Vilanova /ID# 203763 | Valencia | 46015 | Spain |
| Whipps Cross Univ Hospital /ID# 204723 | London | London, City of | E11 1NR | United Kingdom |
| Guy's and St Thomas' NHS Found /ID# 204721 | London | London, City of | SE1 9RT | United Kingdom |
| The University of Manchester /ID# 204720 | Salford | M6 8HD | United Kingdom |
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France). |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab | Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48. |
| BG001 | Risankizumab | Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France). |
| 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, Customized | Count of Participants | Participants |
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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 (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data. | Intent to Treat (ITT) analysis set: all participants who were randomized at Baseline. Non-responder imputation (NRI) was used for missing data. | Posted | Number | percentage of participants | Week 16 |
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| Primary | Percentage of Participants With a PASI 90 at Week 52 | The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all 3; Almost clear (1) = mean > 0, < 1.5; Mild (2) = mean ≥ 1.5, < 2.5; Moderate (3) = mean ≥ 2.5, < 3.5; and Severe (4) = mean ≥ 3.5. | ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52 | The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data. | Posted | Number | percentage of participants | Week 52 |
|
Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secukinumab | Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48 and received at least one dose of study drug. | 0 | 163 | 6 | 163 | 71 | 163 |
| EG001 | Risankizumab | Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France) and received at least one dose of study drug . | 0 | 164 | 9 | 164 | 66 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ARRHYTHMIA SUPRAVENTRICULAR | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| BASEDOW'S DISEASE | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
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| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| HISTIOCYTIC NECROTISING LYMPHADENITIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| TOXIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
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| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
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| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2019 | Jun 21, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Not provided
| ID | Term |
|---|---|
| C000601773 | risankizumab |
| C555450 | secukinumab |
Not provided
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| Title | Measurements |
|---|---|
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| >/= 65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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