A Phase 3 interventional study of risankizumab in Psoriasis, sponsored by AbbVie. Completed at 9 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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).
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 18 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
For GPP
For EP
Exclusion Criteria:
For GPP
For EP
Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Drug: risankizumab
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
Also known as: ABBV-066 BI 655066
Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at 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.
Time frame: Week 16
Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at 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.
Time frame: Week 16
Percentage of Participants With GPP Achieving GPP Clinical Response at 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.
Time frame: Week 52
Percentage of Participants With EP Achieving EP Clinical Response at 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).
Time frame: Week 52
Percentage of Participants With GPP 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.
Time frame: Week 16
Percentage of Participants With EP Achieving 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. NRI was used for missing data.
Time frame: Week 16
Percentage of Participants With GPP Achieving PASI90 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 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
Percentage of Participants With EP Achieving PASI90 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 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
| Milestone | Risankizumab 75 mg | Risankizumab 150 mg |
|---|---|---|
| Started | 9 | 8 |
| Completed | 8 | 6 |
| Not completed | 1 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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 | GPP Risankizumab 75 mg | GPP Risankizumab 150 mg |
|---|---|---|
| Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 | 100 | 100 |
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.
| percentage of participants | EP Risankizumab 75 mg | EP Risankizumab 150 mg |
|---|---|---|
| Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 | 100 | 100 |
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.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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 | GPP Risankizumab 75 mg | GPP Risankizumab 150 mg |
|---|---|---|
| Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 | 100 | 75 |
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 | EP Risankizumab 75 mg | EP Risankizumab 150 mg |
|---|---|---|
| Percentage of Participants With EP Achieving PASI90 at Week 16 | 60 | 100 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GPP Risankizumab 75 mg | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| GPP Risankizumab 150 mg | 0/4 (0%) | 2/4 (50%) | 4/4 (100%) |
| EP Risankizumab 75 mg | 0/5 (0%) | 1/5 (20%) | 3/5 (60%) |
| EP Risankizumab 150 mg | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Event | GPP Risankizumab 75 mg | GPP Risankizumab 150 mg | EP Risankizumab 75 mg | EP Risankizumab 150 mg |
|---|---|---|---|---|
| Alcoholic liver diseaseHepatobiliary disorders | 0/4 | 1/4 | 0/5 | 0/4 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/4 | 1/4 | 0/5 | 0/4 |
| Calculus urinaryRenal and urinary disorders | 0/4 | 0/4 | 0/5 | 1/4 |
| Adrenal insufficiencyEndocrine disorders | 0/4 | 0/4 | 1/5 | 0/4 |
| Urinary tract infectionInfections and infestations | 0/4 | 0/4 | 1/5 | 0/4 |
| Event | GPP Risankizumab 75 mg | GPP Risankizumab 150 mg | EP Risankizumab 75 mg | EP Risankizumab 150 mg |
|---|---|---|---|---|
| Viral upper respiratory tract infectionInfections and infestations | 1/4 | 1/4 | 3/5 | 3/4 |
| Otitis mediaInfections and infestations | 0/4 | 0/4 | 0/5 | 2/4 |
| DehydrationMetabolism and nutrition disorders | 0/4 | 2/4 | 0/5 | 0/4 |
| Abdominal pain upperGastrointestinal disorders | 0/4 | 1/4 | 0/5 | 0/4 |
| ConstipationGastrointestinal disorders | 0/4 | 1/4 | 1/5 | 0/4 |
| VomitingGastrointestinal disorders | 0/4 | 1/4 | 0/5 | 0/4 |
| InflammationGeneral disorders | 0/4 | 1/4 | 0/5 | 0/4 |
| PyrexiaGeneral disorders | 0/4 | 1/4 | 0/5 | 0/4 |
| Hepatic function abnormalHepatobiliary disorders | 1/4 | 1/4 | 0/5 | 0/4 |
| Bronchitis viralInfections and infestations | 0/4 | 0/4 | 0/5 | 1/4 |
| Age, Continuous(years) | Risankizumab 75 mg | Risankizumab 150 mg | Total |
|---|---|---|---|
| Mean | 52.1 ± 20.76 | 44.1 ± 20.13 | 48.40 ± 20.24 |
| Sex: Female, Male(Participants) | Risankizumab 75 mg | Risankizumab 150 mg | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 8 | 6 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Risankizumab 75 mg | Risankizumab 150 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 8 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Risankizumab 75 mg | Risankizumab 150 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 9 | 8 | 17 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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