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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

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ClinicalTrials.gov Identifier: NCT03022045
Recruitment Status : Active, not recruiting
First Posted : January 16, 2017
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: risankizumab
Enrollment 18
Recruitment Details  
Pre-assignment Details 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
Hide 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 [1] 8 6
Not Completed 1 2
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             1             1
[1]
As of the interim analysis data cutoff (14 December 2018)
Arm/Group Title Risankizumab 75 mg Risankizumab 150 mg Total
Hide 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 Number of Baseline Participants 9 8 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 8 participants 17 participants
52.1  (20.76) 44.1  (20.13) 48.40  (20.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
Female 1 2 3
Male 8 6 14
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
Hispanic or Latino 0 0 0
Not Hispanic or Latino 9 8 17
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
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
1.Primary Outcome
Title Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GPP Risankizumab 75 mg GPP Risankizumab 150 mg
Hide 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.
Overall Number of Participants Analyzed 4 4
Measure Type: Number
Unit of Measure: percentage of participants
100 100
2.Primary Outcome
Title Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EP Risankizumab 75 mg EP Risankizumab 150 mg
Hide 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.
Overall Number of Participants Analyzed 5 4
Measure Type: Number
Unit of Measure: percentage of participants
100 100
3.Secondary Outcome
Title Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52
Hide 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 Not Reported
4.Secondary Outcome
Title Percentage of Participants With EP Achieving EP Clinical Response at Week 52
Hide 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 Not Reported
5.Secondary Outcome
Title Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GPP Risankizumab 75 mg GPP Risankizumab 150 mg
Hide 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.
Overall Number of Participants Analyzed 4 4
Measure Type: Number
Unit of Measure: percentage of participants
100 75
6.Secondary Outcome
Title Percentage of Participants With EP Achieving PASI90 at Week 16
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EP Risankizumab 75 mg EP Risankizumab 150 mg
Hide 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.
Overall Number of Participants Analyzed 5 4
Measure Type: Number
Unit of Measure: percentage of participants
60 100
7.Secondary Outcome
Title Percentage of Participants With GPP Achieving PASI90 at Week 52
Hide 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 Not Reported
8.Secondary Outcome
Title Percentage of Participants With EP Achieving PASI90 at Week 52
Hide 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 Not Reported
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/4 (0.00%)      0/5 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide 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 (0.00%)      2/4 (50.00%)      1/5 (20.00%)      1/4 (25.00%)    
Endocrine disorders         
Adrenal insufficiency  1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0
Hepatobiliary disorders         
Alcoholic liver disease  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations         
Urinary tract infection  1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Gastric cancer  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Renal and urinary disorders         
Calculus urinary  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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 (100.00%)      4/4 (100.00%)      3/5 (60.00%)      4/4 (100.00%)    
Gastrointestinal disorders         
Abdominal pain upper  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Constipation  1  0/4 (0.00%)  0 1/4 (25.00%)  1 1/5 (20.00%)  1 0/4 (0.00%)  0
Diarrhoea  1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0
Vomiting  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
General disorders         
Inflammation  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Pyrexia  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Hepatobiliary disorders         
Hepatic function abnormal  1  1/4 (25.00%)  1 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations         
Bronchitis viral  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1
Ear infection  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Gastroenteritis  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  2
Otitis media  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 2/4 (50.00%)  2
Pharyngitis  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1
Upper respiratory tract infection  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1
Viral upper respiratory tract infection  1  1/4 (25.00%)  1 1/4 (25.00%)  1 3/5 (60.00%)  4 3/4 (75.00%)  4
Injury, poisoning and procedural complications         
Contusion  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1
Facial bones fracture  1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0
Aspartate aminotransferase increased  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0
Blood bilirubin increased  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1
Gamma-glutamyltransferase increased  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Dehydration  1  0/4 (0.00%)  0 2/4 (50.00%)  2 0/5 (0.00%)  0 0/4 (0.00%)  0
Hypoglycaemia  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0
Osteoarthritis  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0
Pain in extremity  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Synovial cyst  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1
Psychiatric disorders         
Depression  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Insomnia  1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders         
Acne  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 1/4 (25.00%)  1
Drug eruption  1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0
Erythema  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0
Haemorrhage subcutaneous  1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Rash  1  1/4 (25.00%)  1 1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0
Urticaria  1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03022045     History of Changes
Other Study ID Numbers: M15-988
First Submitted: January 13, 2017
First Posted: January 16, 2017
Results First Submitted: September 6, 2018
Results First Posted: February 6, 2019
Last Update Posted: February 6, 2019