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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
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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
Generalized Pustular Psoriasis Erythrodermic Psoriasis Drug: risankizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 26, 2017
Actual Primary Completion Date : September 17, 2017
Estimated Study Completion Date : January 14, 2021


Arm Intervention/treatment
Experimental: Risankizumab Dose 1
Risankizumab dose 1 administered by subcutaneous injection.
Drug: risankizumab
risankizumab administered by subcutaneous injection.
Other Name: ABBV-066 BI 655066

Experimental: Risankizumab Dose 2
Risankizumab dose 2 administered by subcutaneous injection.
Drug: risankizumab
risankizumab administered by subcutaneous injection.
Other Name: ABBV-066 BI 655066




Primary Outcome Measures :
  1. Subjects 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.

  2. Subjects 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.


Secondary Outcome Measures :
  1. Subjects With GPP Achieving GPP Clinical Response at Week 52 [ Time Frame: Week 52 ]
    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.

  2. Subjects with EP Achieving Clinical Response at Week 52 [ Time Frame: Week 52 ]
    EP Clinical Response, defined as at least "Minimally Improved" in Clinical Global Impression-Global Improvement (CGI-GI) for EP.

  3. Subjects with EP Achieving PASI 90 at Week 52 [ Time Frame: Week 52 ]
    The PASI is used to evaluate a subject's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.

  4. Subjects with EP Achieving PASI 90 at Week 16 [ Time Frame: Week 16 ]
    The PASI is used to evaluate a subject's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.

  5. Subjects with GPP Achieving PASI 90 at Week 52 [ Time Frame: Week 52 ]
    The PASI is used to evaluate a subject's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.

  6. Subjects with GPP Achieving >= 90% Reduction from Baseline Psoriasis Area Severity Index (PASI) score (PASI 90) at Week 16 [ Time Frame: Week 16 ]
    The PASI is used to evaluate a subject's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For generalized pustular psoriasis

  • Have a diagnosis of generalized pustular psoriasis 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 generalized pustular psoriasis, as assessed by the investigator.

For erythrodermic psoriasis

  • Have a diagnosis of erythrodermic psoriasis 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 erythrodermic psoriasis, 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 generalized pustular psoriasis

  • Subjects with active ongoing inflammatory diseases other than generalized pustular psoriasis that might confound trial evaluations according to investigator's judgment.

For erythrodermic psoriasis

  • Subjects with active ongoing inflammatory diseases other than erythrodermic psoriasis that might confound trial evaluations according to investigator's judgment.
  • Subject diagnosed with medication-induced or medication-exacerbated EP.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022045


Locations
Japan
Nagoya City University Hospital
Nagoya-shi, Aichi, Japan, 467-8602
Juntendo Univ Urayasu Hosp
Urayasu Shi, Chiba, Japan, 279-0021
Takagi Dermatological Clinic
Obihiro, Hokkaido, Japan, 080-0013
Mie University Hospital
Tsu-shi, Mie, Japan, 514-8507
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan, 573-1191
Shizuoka General Hospital
静岡市, Shizuoka, Japan, 〒420-8527
Tokyo Medical University Hosp
Shinjuku-ku, Tokyo, Japan, 160-0023
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
The University of Tokyo Hosp
Tokyo, Japan, 113-0033
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03022045     History of Changes
Other Study ID Numbers: M15-988
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Generalized Pustular Psoriasis
Erythrodermic Psoriasis
risankizumab
Japanese

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases