PsoriasisPhase 3NCT03022045

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

A Phase 3 study testing risankizumab in people with Psoriasis, run by AbbVie at 9 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Psoriasis
What is being tested?: risankizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 9 sitesJapan
Study dates: 26 Jan 2017to 19 Nov 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Japan9 sites

Fukuoka University Hospital
Fukuoka, 814-0180
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Takagi Dermatological Clinic
Obihiro, Hokkaido, 080-0013
Tokyo Medical University Hosp
Shinjuku-ku, Tokyo, 160-0023
Shizuoka General Hospital
Shizuoka, Shizuoka, 〒420-8527
The University of Tokyo Hosp
Tokyo, 113-0033
Mie University Hospital
Tsu, Mie-ken, 514-8507
Juntendo Univ Urayasu Hosp
Urayasu Shi, Chiba, 279-0021

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Open-Label 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

Read the 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.

Conditions: Psoriasis
Being tested: risankizumab
Keywords: Generalized Pustular Psoriasis, Erythrodermic Psoriasis, risankizumab, Japanese
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

risankizumabDrug
Also called ABBV-066 BI 655066
risankizumab administered by subcutaneous injection

Study groups in NCT03022045
Study group	Role	What they receive
Risankizumab 75 mg	Experimental	Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. Receives: Drug: risankizumab
Risankizumab 150 mg	Experimental	Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. Receives: Drug: risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Week 16

Secondary outcomes (6)

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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 201719 Nov 2020

First posted16 Jan 2017 (estimated)
Study start26 Jan 2017
Primary completion17 Sep 2017
Study completion19 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03022045
Sponsor's protocol ID: M15-988
Status last verified: Nov 2021
First submitted: 13 Jan 2017
Last updated: 18 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
PubMed 31667790

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Open-Label 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
ClinicalTrials.gov ID: NCT03022045
Acronym / sponsor ID: M15-988
Conditions: Psoriasis
Keywords: Generalized Pustular Psoriasis, Erythrodermic Psoriasis, risankizumab, Japanese
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 26 Jan 2017 (actual)
Primary completion: 17 Sep 2017 (actual)
Study completion: 19 Nov 2020 (actual)
First posted: 16 Jan 2017 (estimated)
Results: Posted 6 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Risankizumab 75 mg	Experimental	Drug: risankizumabParticipants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Risankizumab 150 mg	Experimental	Drug: risankizumabParticipants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
risankizumabAlso: ABBV-066 BI 655066risankizumab administered by subcutaneous injection	Drug	Risankizumab 150 mg, Risankizumab 75 mg

Primary outcome

Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16
Time frame: 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
Time frame: 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.

6 secondary outcomes

Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52
Time frame: Week 52
Percentage of Participants With EP Achieving EP Clinical Response at Week 52
Time frame: Week 52
Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16
Time frame: Week 16
Percentage of Participants With EP Achieving PASI90 at Week 16
Time frame: Week 16
Percentage of Participants With GPP Achieving PASI90 at Week 52
Time frame: Week 52
Percentage of Participants With EP Achieving PASI90 at Week 52
Time frame: Week 52

Results and safety

Results posted to the registry on 6 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Risankizumab 75 mg	9	8
Risankizumab 150 mg	8	6

Primary outcome: Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16

Time frame: Week 16. Number. Unit: percentage of participants

Measure	GPP Risankizumab 75 mg n = 4	GPP Risankizumab 150 mg n = 4
Value	100	100

Primary outcome: Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16

Time frame: Week 16. Number. Unit: percentage of participants

Measure	EP Risankizumab 75 mg n = 5	EP Risankizumab 150 mg n = 4
Value	100	100

6 secondary outcomes are reported in the full results.

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GPP Risankizumab 75 mg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
GPP Risankizumab 150 mg	2 of 4 (50%)	4 of 4 (100%)	0 of 4
EP Risankizumab 75 mg	1 of 5 (20%)	3 of 5 (60%)	0 of 5
EP Risankizumab 150 mg	1 of 4 (25%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31667790Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
clinical study report synopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Related trials for Psoriasis

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Recruiting
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Active, not recruitingPhase 2
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RecruitingPhase 1
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RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc. study director

AbbVie

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risankizumab in people with Psoriasis, run by AbbVie at 9 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03022045, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.