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 | Completed Phase 3 Results DMC

• 1 other identifier: M15-988
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 9

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).

Conditions

Psoriasis

Keywords

Generalized Pustular Psoriasis; Erythrodermic Psoriasis; risankizumab; Japanese

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Week 16

Secondary Outcomes (6)

• Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52

  Week 52

• Percentage of Participants With EP Achieving EP Clinical Response at Week 52

  Week 52

• 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 With EP Achieving PASI90 at Week 16

  Week 16

• Percentage of Participants With GPP Achieving PASI90 at Week 52

  Week 52

Study Arms (2)

Risankizumab 75 mg

EXPERIMENTAL

Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.

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.

Drug: risankizumab

Interventions

risankizumab DRUG

risankizumab administered by subcutaneous injection

Also known as: ABBV-066 BI 655066

Risankizumab 150 mg; Risankizumab 75 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (9)

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Juntendo Univ Urayasu Hosp

Urayasu Shi, Chiba, 279-0021, Japan

Location

Takagi Dermatological Clinic

Obihiro, Hokkaido, 080-0013, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

Location

Shizuoka General Hospital

Shizuoka, Shizuoka, 〒420-8527, Japan

Location

Tokyo Medical University Hosp

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

The University of Tokyo Hosp

Tokyo, 113-0033, Japan

Location

Related Publications (1)

• 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.

  PMID: 31667790 DERIVED

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 16, 2017
• Study Start: January 26, 2017
• Primary Completion: September 17, 2017
• Study Completion: November 19, 2020
• Last Updated: November 18, 2021
• Results First Posted: February 6, 2019

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

JP (9)