A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the safety and efficacy of two different dose regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
Safety and efficacy data through 14 December 2017 are included in the interim analysis, which was conducted after all participants completed the Week 28 visit or discontinued from the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Risankizumab 75 mg Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. |
Drug: risankizumab
risankizumab administered by subcutaneous injection
Other Names:
|
| Experimental: Risankizumab 150 mg Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. |
Drug: risankizumab
risankizumab administered by subcutaneous injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 [Week 16]
GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, white blood count [WBC], serum C-reactive protein [CRP], and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria. Nonresponder imputation (NRI) was used for missing data.
- Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 [Week 16]
EP Clinical Response, defined as at least "Minimally Improved" in Clinical Global Impression-Global Improvement (CGI-GI) for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse). NRI was used for missing data.
Secondary Outcome Measures
- Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52 [Week 52]
GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to JDA total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, WBC, serum CRP, and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria.
- Percentage of Participants With EP Achieving EP Clinical Response at Week 52 [Week 52]
EP Clinical Response, defined as at least "Minimally Improved" in CGI-GI for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse).
- Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 [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.
- Percentage of Participants With EP Achieving PASI90 at Week 16 [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. NRI was used for missing data.
- Percentage of Participants With GPP Achieving PASI90 at Week 52 [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 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.
- Percentage of Participants With EP Achieving PASI90 at Week 52 [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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
For GPP
-
Have a diagnosis of GPP for at least 60 days prior to informed consent based on the diagnostic criteria of the Japanese Dermatological Association (JDA). Subjects not fulfilling one of the diagnostic criteria i.e., "accompanying systemic symptoms including fever or malaise" at the time of screening can be entered.
-
Subjects with an erythema area with pustules accounting for ≥ 10% of the body surface area (BSA), and with a severity assessment criteria score (JDA total score) specified by the JDA of less than 14.
-
Must be candidates for systemic therapy or phototherapy for GPP, as assessed by the investigator.
For EP
-
Have a diagnosis of EP prior to informed consent.
-
Subjects with an inflammatory erythema area accounting for ≥ 80% of the BSA at screening and at the time of the first administration of the study drug.
-
Must be candidates for systemic therapy or phototherapy for EP, as assessed by the investigator.
Exclusion Criteria:
-
Previous exposure to risankizumab.
-
Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted).
For GPP
- Subjects with active ongoing inflammatory diseases other than GPP that might confound trial evaluations according to investigator's judgment.
For EP
-
Subjects with active ongoing inflammatory diseases other than EP that might confound trial evaluations according to investigator's judgment.
-
Subject diagnosed with medication-induced or medication-exacerbated EP.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nagoya City University Hospital | Nagoya-shi | Aichi | Japan | 467-8602 |
| 2 | Juntendo Univ Urayasu Hosp | Urayasu Shi | Chiba | Japan | 279-0021 |
| 3 | Takagi Dermatological Clinic | Obihiro | Hokkaido | Japan | 080-0013 |
| 4 | Mie University Hospital | Tsu-shi | Mie | Japan | 514-8507 |
| 5 | Kansai Medical University Hospital | Hirakata-shi | Osaka | Japan | 573-1191 |
| 6 | Shizuoka General Hospital | 静岡市 | Shizuoka | Japan | 〒420-8527 |
| 7 | Tokyo Medical University Hosp | Shinjuku-ku | Tokyo | Japan | 160-0023 |
| 8 | Fukuoka University Hospital | Fukuoka | Japan | 814-0180 | |
| 9 | The University of Tokyo Hosp | Tokyo | Japan | 113-0033 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- M15-988
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 18 subjects were enrolled; 1 subject failed screening and are excluded from the analyses. |
| Arm/Group Title | Risankizumab 75 mg | Risankizumab 150 mg |
|---|---|---|
| Arm/Group Description | Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. |
| Period Title: Overall Study | ||
| STARTED | 9 | 8 |
| COMPLETED | 8 | 6 |
| NOT COMPLETED | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Risankizumab 75 mg | Risankizumab 150 mg | Total |
|---|---|---|---|
| Arm/Group Description | Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Total of all reporting groups |
| Overall Participants | 9 | 8 | 17 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
52.1
(20.76)
|
44.1
(20.13)
|
48.40
(20.24)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
11.1%
|
2
25%
|
3
17.6%
|
| Male |
8
88.9%
|
6
75%
|
14
82.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
9
100%
|
8
100%
|
17
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
9
100%
|
8
100%
|
17
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 |
|---|---|
| Description | GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, white blood count [WBC], serum C-reactive protein [CRP], and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria. Nonresponder imputation (NRI) was used for missing data. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | GPP Risankizumab 75 mg | GPP Risankizumab 150 mg |
|---|---|---|
| Arm/Group Description | Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. |
| Measure Participants | 4 | 4 |
| Number [percentage of participants] |
100
1111.1%
|
100
1250%
|
| Title | Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 |
|---|---|
| Description | EP Clinical Response, defined as at least "Minimally Improved" in Clinical Global Impression-Global Improvement (CGI-GI) for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse). NRI was used for missing data. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | EP Risankizumab 75 mg | EP Risankizumab 150 mg |
|---|---|---|
| Arm/Group Description | Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. |
| Measure Participants | 5 | 4 |
| Number [percentage of participants] |
100
1111.1%
|
100
1250%
|
| Title | Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52 |
|---|---|
| Description | GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to JDA total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, WBC, serum CRP, and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria. |
| Time Frame | Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Percentage of Participants With EP Achieving EP Clinical Response at Week 52 |
|---|---|
| Description | EP Clinical Response, defined as at least "Minimally Improved" in CGI-GI for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse). |
| Time Frame | Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 |
|---|---|
| Description | 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. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | GPP Risankizumab 75 mg | GPP Risankizumab 150 mg |
|---|---|---|
| Arm/Group Description | Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. |
| Measure Participants | 4 | 4 |
| Number [percentage of participants] |
100
1111.1%
|
75
937.5%
|
| Title | Percentage of Participants With EP Achieving PASI90 at Week 16 |
|---|---|
| Description | 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. NRI was used for missing data. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | EP Risankizumab 75 mg | EP Risankizumab 150 mg |
|---|---|---|
| Arm/Group Description | Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. |
| Measure Participants | 5 | 4 |
| Number [percentage of participants] |
60
666.7%
|
100
1250%
|
| Title | Percentage of Participants With GPP Achieving PASI90 at Week 52 |
|---|---|
| Description | 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. |
| Time Frame | Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Percentage of Participants With EP Achieving PASI90 at Week 52 |
|---|---|
| Description | 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. |
| Time Frame | Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug. | |||||||
| Arm/Group Title | GPP Risankizumab 75 mg | GPP Risankizumab 150 mg | EP Risankizumab 75 mg | EP Risankizumab 150 mg | ||||
| Arm/Group Description | Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. | ||||
All Cause Mortality |
||||||||
| GPP Risankizumab 75 mg | GPP Risankizumab 150 mg | EP Risankizumab 75 mg | EP Risankizumab 150 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 0/4 (0%) | 0/5 (0%) | 0/4 (0%) | ||||
Serious Adverse Events |
||||||||
| GPP Risankizumab 75 mg | GPP Risankizumab 150 mg | EP Risankizumab 75 mg | EP Risankizumab 150 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 2/4 (50%) | 1/5 (20%) | 1/4 (25%) | ||||
| Endocrine disorders | ||||||||
| Adrenal insufficiency | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Alcoholic liver disease | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Infections and infestations | ||||||||
| Urinary tract infection | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Gastric cancer | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Calculus urinary | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| GPP Risankizumab 75 mg | GPP Risankizumab 150 mg | EP Risankizumab 75 mg | EP Risankizumab 150 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/4 (100%) | 4/4 (100%) | 3/5 (60%) | 4/4 (100%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain upper | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Constipation | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Diarrhoea | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Vomiting | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| General disorders | ||||||||
| Inflammation | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Pyrexia | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Hepatic function abnormal | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Infections and infestations | ||||||||
| Bronchitis viral | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Ear infection | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Gastroenteritis | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 2 |
| Otitis media | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/4 (50%) | 2 |
| Pharyngitis | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Upper respiratory tract infection | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Viral upper respiratory tract infection | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 3/5 (60%) | 4 | 3/4 (75%) | 4 |
| Injury, poisoning and procedural complications | ||||||||
| Contusion | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Facial bones fracture | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Investigations | ||||||||
| Alanine aminotransferase increased | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Aspartate aminotransferase increased | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Blood bilirubin increased | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Gamma-glutamyltransferase increased | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Dehydration | 0/4 (0%) | 0 | 2/4 (50%) | 2 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Hypoglycaemia | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Intervertebral disc protrusion | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Osteoarthritis | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Pain in extremity | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Synovial cyst | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Psychiatric disorders | ||||||||
| Depression | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Insomnia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Acne | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Drug eruption | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Erythema | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Haemorrhage subcutaneous | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Rash | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Urticaria | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
- M15-988