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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003625-34 | EudraCT Number | ||
| 1311.5 | Other Identifier | Boehringer Ingelheim |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066/ABBV-066/risankizumab in adult patients with psoriatic arthritis in order to select doses for further clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks. |
|
| Risankizumab 150 mg Every 4 Weeks | Experimental | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks. |
|
| Risankizumab 150 mg Weeks 0, 4, and 16 | Experimental | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16. |
|
| Risankizumab 150 mg Weeks 0 and 12 | Experimental | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12. |
|
| Risankizumab 75 mg Week 0 | Experimental | Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risankizumab | Drug | Risankizumab administered by SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16 | Response defined by ACR20 criteria (improvement from baseline) at Week 16: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters:
Nonresponder imputation (NRI) was used for missing data. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16 | Response defined by ACR50 criteria (improvement from baseline) at Week 16: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters:
NRI was used for missing data. |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36178584 | Derived | Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30. | |
| 35931879 | Derived | Mease PJ, Kellner H, Morita A, Kivitz AJ, Aslanyan S, Padula SJ, Topp AS, Eldred A, Behrens F, Papp KA. Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial. Rheumatol Ther. 2022 Oct;9(5):1361-1375. doi: 10.1007/s40744-022-00474-5. Epub 2022 Aug 5. |
| Label | URL |
|---|---|
| Related Info | View source |
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This study included a 6-week screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks. |
| FG001 | Risankizumab 150 mg Every 4 Weeks | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks. |
| FG002 | Risankizumab 150 mg Weeks 0, 4, and 16 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16. |
| FG003 | Risankizumab 150 mg Weeks 0 and 12 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12. |
| FG004 | Risankizumab 75 mg Week 0 | Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks. |
| BG001 | Risankizumab 150 mg Every 4 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Achieving American College of Rheumatology 20% (ACR20) Response at Week 16 | Response defined by ACR20 criteria (improvement from baseline) at Week 16: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters:
Nonresponder imputation (NRI) was used for missing data. | FAS | Posted | Number | 90% Confidence Interval | percentage of participants | Week 16 |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
Not provided
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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 | Placebo | Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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 | Oct 12, 2016 | Dec 19, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2017 | Dec 19, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
Not provided
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo for risankizumab | Drug | Placebo for risankizumab administered by SC injection |
|
| Week 16 |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16 | Response defined by ACR70 criteria (improvement from baseline) at Week 16: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters:
NRI was used for missing data. | Week 16 |
| Tender Joint Count (TJC68): Change From Baseline to Week 16 | Sixty-eight joints were assessed and classified as either tender (1) or not tender (0). A negative change represents a decrease in the number of tender joints. | Baseline, Week 16 |
| Swollen Joint Count (SJC): Change From Baseline to Week 16 | Sixty-six joints were assessed and classified as either swollen (1) or not swollen (0). A negative change represents a decrease in the number of tender joints. | Baseline, Week 16 |
| Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change From Baseline to Week 16 | The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. A negative change from Baseline indicates improvement. | Baseline, Week 16 |
| Short Form-36 Health Status Survey (SF-36) Physical Component: Change From Baseline to Week 16 | The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. | Baseline, Week 16 |
| SF-36 Mental Component: Change From Baseline to Week 16 | The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. | Baseline, Week 16 |
| Dactylitis Count: Change From Baseline to Week 16 in Participants With Dactylitis at Baseline | The number of fingers and toes with dactylitis (ranging from 0 to 20). A negative change represents a decrease in the number of fingers and toes affected by dactylitis. | Baseline, Week 16 |
| Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Change From Baseline to Week 16 in Participants With Enthesitis at Baseline | Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was classified as either absent (0) or present (1) to yield total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (16 sites with tenderness). A negative change from Baseline indicates improvement. | Baseline, Week 16 |
| Modified Nail Psoriasis Severity Index (mNAPSI): Change From Baseline to Week 16 | mNAPSI grades each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail); pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (>50 pits present); nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling); and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. mNAPSI is calculated as the sum of all the components for all of the participants fingernails, for a minimal - maximal total score of 0 to 130. A negative change from Baseline indicates improvement. | Baseline, Week 16 |
| Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 | 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 severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 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. The percentage of participants achieving PASI90 at Week 16 are provided. NRI was used for missing data. | Week 16 |
| Lost to Follow-up |
|
| Subject Withdrawal |
|
| Other |
|
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
| BG002 | Risankizumab 150 mg Weeks 0, 4, and 16 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16. |
| BG003 | Risankizumab 150 mg Weeks 0 and 12 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12. |
| BG004 | Risankizumab 75 mg Week 0 | Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| OG001 | Risankizumab 150 mg Every 4 Weeks | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks. |
| OG002 | Risankizumab 150 mg Weeks 0, 4, and 16 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16. |
| OG003 | Risankizumab 150 mg Weeks 0 and 12 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12. |
| OG004 | Risankizumab 75 mg Week 0 | Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0. |
| OG005 | Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16. |
| OG006 | Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12. |
|
|
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16 | Response defined by ACR50 criteria (improvement from baseline) at Week 16: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters:
NRI was used for missing data. | FAS | Posted | Number | 90% Confidence Interval | percentage of participants | Week 16 |
|
|
|
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16 | Response defined by ACR70 criteria (improvement from baseline) at Week 16: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters:
NRI was used for missing data. | FAS | Posted | Number | 90% Confidence Interval | percentage of participants | Week 16 |
|
|
|
|
| Secondary | Tender Joint Count (TJC68): Change From Baseline to Week 16 | Sixty-eight joints were assessed and classified as either tender (1) or not tender (0). A negative change represents a decrease in the number of tender joints. | Participants in the FAS with available data at Baseline and Week 16. | Posted | Least Squares Mean | 90% Confidence Interval | tender joints | Baseline, Week 16 |
|
|
|
|
| Secondary | Swollen Joint Count (SJC): Change From Baseline to Week 16 | Sixty-six joints were assessed and classified as either swollen (1) or not swollen (0). A negative change represents a decrease in the number of tender joints. | Participants in the FAS with available data at Baseline and Week 16. | Posted | Least Squares Mean | 90% Confidence Interval | swollen joints | Baseline, Week 16 |
|
|
|
|
| Secondary | Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change From Baseline to Week 16 | The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. A negative change from Baseline indicates improvement. | Participants in the FAS with available data at Baseline and Week 16. | Posted | Least Squares Mean | 90% Confidence Interval | units on a scale | Baseline, Week 16 |
|
|
|
|
| Secondary | Short Form-36 Health Status Survey (SF-36) Physical Component: Change From Baseline to Week 16 | The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. | Participants in the FAS with available data at Baseline and Week 16. | Posted | Least Squares Mean | 90% Confidence Interval | units on a scale | Baseline, Week 16 |
|
|
|
|
| Secondary | SF-36 Mental Component: Change From Baseline to Week 16 | The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. | Participants in the FAS with available data at Baseline and Week 16. | Posted | Least Squares Mean | 90% Confidence Interval | units on a scale | Baseline, Week 16 |
|
|
|
|
| Secondary | Dactylitis Count: Change From Baseline to Week 16 in Participants With Dactylitis at Baseline | The number of fingers and toes with dactylitis (ranging from 0 to 20). A negative change represents a decrease in the number of fingers and toes affected by dactylitis. | Participants in the FAS with available data at Baseline and Week 16. | Posted | Least Squares Mean | 90% Confidence Interval | fingers and toes with dactylitis | Baseline, Week 16 |
|
|
|
|
| Secondary | Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Change From Baseline to Week 16 in Participants With Enthesitis at Baseline | Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was classified as either absent (0) or present (1) to yield total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (16 sites with tenderness). A negative change from Baseline indicates improvement. | Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16. | Posted | Least Squares Mean | 90% Confidence Interval | units on a scale | Baseline, Week 16 |
|
|
|
|
| Secondary | Modified Nail Psoriasis Severity Index (mNAPSI): Change From Baseline to Week 16 | mNAPSI grades each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail); pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (>50 pits present); nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling); and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. mNAPSI is calculated as the sum of all the components for all of the participants fingernails, for a minimal - maximal total score of 0 to 130. A negative change from Baseline indicates improvement. | Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16. | Posted | Least Squares Mean | 90% Confidence Interval | units on a scale | Baseline, Week 16 |
|
|
|
|
| Secondary | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 | 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 severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 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. The percentage of participants achieving PASI90 at Week 16 are provided. NRI was used for missing data. | FAS | Posted | Number | 90% Confidence Interval | percentage of participants | Week 16 |
|
|
|
|
| 0 |
| 42 |
| 2 |
| 42 |
| 25 |
| 42 |
| EG001 | Risankizumab 150 mg Every 4 Weeks | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks. | 0 | 42 | 3 | 42 | 16 | 42 |
| EG002 | Risankizumab 150 mg Weeks 0, 4, and 16 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16. | 0 | 42 | 0 | 42 | 13 | 42 |
| EG003 | Risankizumab 150 mg Weeks 0 and 12 | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12. | 0 | 39 | 2 | 39 | 19 | 39 |
| EG004 | Risankizumab 75 mg Week 0 | Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0. | 0 | 20 | 3 | 20 | 13 | 20 |
| Cardiac failure congestive | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Ovarian cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nasal septal operation | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
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| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.
| Cochran-Mantel-Haenszel |
| 0.007 |
| Mean Difference (Final Values) |
| 19.0 |
| 2-Sided |
| 90 |
| 7.4 |
| 30.6 |
| Other |
The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.
| Cochran-Mantel-Haenszel |
| <0.001 |
| Mean Difference (Final Values) |
| 15.7 |
| 2-Sided |
| 90 |
| 8.5 |
| 22.9 |
| Other |
The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect. |
| mixed model repeated measures model |
| 0.260 |
| Mean Difference (Final Values) |
| -2.1 |
| 2-Sided |
| 90 |
| -5.3 |
| 1.0 |
| Other |
The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect. |
| mixed model repeated measures model |
| 0.320 |
| Mean Difference (Final Values) |
| -1.1 |
| 2-Sided |
| 90 |
| -2.8 |
| 0.7 |
| Other |
The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect. |
| mixed model repeated measures model |
| 0.181 |
| Mean Difference (Final Values) |
| -0.114 |
| 2-Sided |
| 90 |
| -0.254 |
| 0.027 |
| Other |
The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect. |
| mixed model repeated measures model |
| 0.284 |
| Mean Difference (Final Values) |
| 1.35 |
| 2-Sided |
| 90 |
| -0.73 |
| 3.44 |
| Other |
The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect. |
| mixed model repeated measures model |
| 0.204 |
| Mean Difference (Final Values) |
| 2.06 |
| 2-Sided |
| 90 |
| -0.61 |
| 4.74 |
| Other |
The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect. |
| mixed model repeated measures model |
| 0.906 |
| Mean Difference (Final Values) |
| 0.1 |
| 2-Sided |
| 90 |
| -1.0 |
| 1.1 |
| Other |
The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect. |
| mixed model repeated measures model |
| 0.160 |
| Mean Difference (Final Values) |
| -0.9 |
| 2-Sided |
| 90 |
| -2.1 |
| 0.2 |
| Other |
The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect. |
| mixed model repeated measures model |
| 0.111 |
| Mean Difference (Final Values) |
| -2.8 |
| 2-Sided |
| 90 |
| -5.7 |
| 0.1 |
| Other |
The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use. |
| Cochran-Mantel-Haenszel |
| <0.001 |
| Mean Difference (Final Values) |
| 48.8 |
| 2-Sided |
| 90 |
| 33.1 |
| 64.5 |
| Other |