Trial · NCT03022045
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
NCT03022045, Phase 3, Completed, AbbVie; results first posted 2019-02-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 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. Trials, record NCT03022045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03022045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03022045
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 18 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Psoriasis
- Interventions
- risankizumab
- First posted
- 2017-01-16
- Last updated
- 2021-11-18
- Results first posted
- 2019-02-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 | Week 16 | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 | Week 16 | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52 | Week 52 | |||
| SECONDARY | Percentage of Participants With EP Achieving EP Clinical Response at Week 52 | Week 52 | |||
| SECONDARY | Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 | Week 16 | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With EP Achieving PASI90 at Week 16 | Week 16 | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With GPP Achieving PASI90 at Week 52 | Week 52 | |||
| SECONDARY | Percentage of Participants With EP Achieving PASI90 at Week 52 | Week 52 |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 | GPP Risankizumab 75 mg | 100 | percentage of participants | ||
| Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 | GPP Risankizumab 150 mg | 100 | percentage of participants | ||
| Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 | EP Risankizumab 75 mg | 100 | percentage of participants | ||
| Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 | EP Risankizumab 150 mg | 100 | percentage of participants | ||
| Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 | GPP Risankizumab 75 mg | 100 | percentage of participants | ||
| Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 | GPP Risankizumab 150 mg | 75 | percentage of participants | ||
| Percentage of Participants With EP Achieving PASI90 at Week 16 | EP Risankizumab 75 mg | 60 | percentage of participants | ||
| Percentage of Participants With EP Achieving PASI90 at Week 16 | EP Risankizumab 150 mg | 100 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Risankizumab 75 mg | 9 | |
| Overall Study | STARTED | Risankizumab 150 mg | 8 | |
| Overall Study | COMPLETED | Risankizumab 75 mg | 8 | |
| Overall Study | COMPLETED | Risankizumab 150 mg | 6 | |
| Overall Study | NOT COMPLETED | Risankizumab 75 mg | 1 | |
| Overall Study | NOT COMPLETED | Risankizumab 150 mg | 2 |
Source ClinicalTrials.gov
Adverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | GPP Risankizumab 75 mg | 0 | 4 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | GPP Risankizumab 150 mg | 1 | 4 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | EP Risankizumab 75 mg | 0 | 5 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | EP Risankizumab 150 mg | 0 | 4 | 0 |
| other | Constipation | Gastrointestinal disorders | GPP Risankizumab 75 mg | 0 | 4 | 0 |
| other | Constipation | Gastrointestinal disorders | GPP Risankizumab 150 mg | 1 | 4 | 1 |
| other | Constipation | Gastrointestinal disorders | EP Risankizumab 75 mg | 1 | 5 | 1 |
| other | Constipation | Gastrointestinal disorders | EP Risankizumab 150 mg | 0 | 4 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | GPP Risankizumab 75 mg | 0 | 4 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | GPP Risankizumab 150 mg | 0 | 4 | 0 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GPP Risankizumab 75 mg | 0 | 4 |
| Total, all-cause mortality | GPP Risankizumab 150 mg | 0 | 4 |
| Total, all-cause mortality | EP Risankizumab 75 mg | 0 | 5 |
| Total, all-cause mortality | EP Risankizumab 150 mg | 0 | 4 |
| Total, other adverse events | GPP Risankizumab 75 mg | 4 | 4 |
| Total, other adverse events | GPP Risankizumab 150 mg | 4 | 4 |
| Total, other adverse events | EP Risankizumab 75 mg | 3 | 5 |
| Total, other adverse events | EP Risankizumab 150 mg | 4 | 4 |
| Total, serious adverse events | GPP Risankizumab 75 mg | 0 | 4 |
| Total, serious adverse events | GPP Risankizumab 150 mg | 2 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31667790 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03022045
GET https://conductscience.org/api/trials/v1/NCT03022045/events?page=2