Back to resultsA Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Risankizumab
Autoinjector
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Risankizumab, Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit
Participant meets following disease activity criteria:
- Stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 12 at Screening and baseline visit
- Candidate for systemic therapy as assessed by the investigator
Exclusion Criteria:
- Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis
- Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- Participant has previous exposure to risankizumab
Sites / Locations
- Advanced Research Associates /ID# 210634
- Cognitive Clinical Trials /ID# 210770
- Burke Pharmaceutical Research /ID# 211386
- Bakersfield Derma & Skin Cance /ID# 210773
- Encino Research Center / T. Jo /ID# 211735
- Tien Q Nguyen MD, Inc /ID# 210775
- UC Davis Health /ID# 210411
- Dermatology Physicians of CT /ID# 210637
- Florida Academic Centers Research /ID# 210337
- Medallion Clinical Research Institute, LLC /ID# 210329
- Renstar Medical Research /ID# 210878
- Epiphany Dermatology /ID# 211493
- DermAssociates /ID# 210838
- Great Lakes Research, Inc. /ID# 210192
- Somerset Skin Centre /ID# 211596
- Central Dermatology, PC /ID# 210301
- AllCutis Research Inc /ID# 211429
- Medication Management, LLC /ID# 213217
- Oregon Medical Res Center PC /ID# 210334
- University of Pittsburgh MC /ID# 210839
- Center for Clinical Studies /ID# 211565
- Center for Clinical Studies /ID# 210362
- Suzanne Bruce and Associates /ID# 212210
- Austin Institute for Clinical Research /ID# 212203
- Premier Clinical Research /ID# 212209
- Froedtert Mem Lutheran Hosp /ID# 210194
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Risankizumab
Arm Description
Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Outcomes
Primary Outcome Measures
Percentage of Participants With an Observer Rating of Successful Participant Self-administration
Successful participant self-administration is defined as successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the autoinjector. The steps are "chose an appropriate injection site"; "removed cap from autoinjector"; "activated the injection"; and "performed a complete injection".
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
The Psoriasis Area and Severity Index (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. PASI 90 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 Week 16) / PASI score at Baseline * 100.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
The Psoriasis Area and Severity Index (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. PASI 100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16
The Psoriasis Area and Severity Index (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. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.
Percentage of Participants Who Had No Potential Hazards as Measured by an Observer
Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with the autoinjector. Hazards include injection at incorrect site; administration delayed because of cap removal difficulties; slip hazard during cap disposal attempt; small component swallowed after incorrect disposal of cap; patient received less medication than intended; needle shield did not deploy and resulted in sharps exposure; and pen not discarded properly and resulted in a biohazard for others.
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)
Participants completed the Self-Injection Assessment Questionnaire (SIAQ), an instrument previously validated in those with rheumatoid arthritis, on an electronic patient-report outcome (ePRO) device. The POST module includes four principal causal domains: feelings about injections, self-confidence, pain and reaction during or after the injection, and ease of use, plus two additional domains on satisfaction with self-injection and self-image. Participants rate each item of the SIAQ 20 to 40 minutes following injections, and the ratings are transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Higher domain scores indicate wider acceptability by subjects to use the autoinjector.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03875508
Brief Title
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Official Title
Plaque Psoriasis: Usability of the Risankizumab Autoinjector Combination Product in Adults With Moderate to Severe Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
April 24, 2020 (Actual)
Study Completion Date
August 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.
Detailed Description
This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 was self-administered at home.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Risankizumab, Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risankizumab
Arm Type
Experimental
Arm Description
Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
ABBV-066, BI 655066
Intervention Description
Risankizumab to be injected subcutaneously (SC)
Intervention Type
Device
Intervention Name(s)
Autoinjector
Intervention Description
Single dose pre-filled autoinjector containing risankizumab for SC injection
Primary Outcome Measure Information:
Title
Percentage of Participants With an Observer Rating of Successful Participant Self-administration
Description
Successful participant self-administration is defined as successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the autoinjector. The steps are "chose an appropriate injection site"; "removed cap from autoinjector"; "activated the injection"; and "performed a complete injection".
Time Frame
Day 1 and Week 28
Title
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
Description
The Psoriasis Area and Severity Index (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. PASI 90 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 Week 16) / PASI score at Baseline * 100.
Time Frame
At Week 16
Title
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16
Description
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
Time Frame
At Week 16
Title
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
Description
The Psoriasis Area and Severity Index (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. PASI 100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.
Time Frame
At Week 16
Title
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16
Description
The Psoriasis Area and Severity Index (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. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.
Time Frame
At Week 16
Title
Percentage of Participants Who Had No Potential Hazards as Measured by an Observer
Description
Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with the autoinjector. Hazards include injection at incorrect site; administration delayed because of cap removal difficulties; slip hazard during cap disposal attempt; small component swallowed after incorrect disposal of cap; patient received less medication than intended; needle shield did not deploy and resulted in sharps exposure; and pen not discarded properly and resulted in a biohazard for others.
Time Frame
Day 1 and Week 28
Title
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)
Description
Participants completed the Self-Injection Assessment Questionnaire (SIAQ), an instrument previously validated in those with rheumatoid arthritis, on an electronic patient-report outcome (ePRO) device. The POST module includes four principal causal domains: feelings about injections, self-confidence, pain and reaction during or after the injection, and ease of use, plus two additional domains on satisfaction with self-injection and self-image. Participants rate each item of the SIAQ 20 to 40 minutes following injections, and the ratings are transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Higher domain scores indicate wider acceptability by subjects to use the autoinjector.
Time Frame
Day 1, Week 4, Week 16, Week 28
Other Pre-specified Outcome Measures:
Title
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16
Description
The Psoriasis Area and Severity Index (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. Negative values indicate an improvement from baseline.
Time Frame
Baseline, Week 4, and Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit
Participant meets following disease activity criteria:
Stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 12 at Screening and baseline visit
Candidate for systemic therapy as assessed by the investigator
Exclusion Criteria:
Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis
Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
Participant has previous exposure to risankizumab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Research Associates /ID# 210634
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Cognitive Clinical Trials /ID# 210770
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258-4446
Country
United States
Facility Name
Burke Pharmaceutical Research /ID# 211386
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913-6404
Country
United States
Facility Name
Bakersfield Derma & Skin Cance /ID# 210773
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Encino Research Center / T. Jo /ID# 211735
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Tien Q Nguyen MD, Inc /ID# 210775
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-3701
Country
United States
Facility Name
UC Davis Health /ID# 210411
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Dermatology Physicians of CT /ID# 210637
City
Shelton
State/Province
Connecticut
ZIP/Postal Code
06484-6211
Country
United States
Facility Name
Florida Academic Centers Research /ID# 210337
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Medallion Clinical Research Institute, LLC /ID# 210329
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Renstar Medical Research /ID# 210878
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Epiphany Dermatology /ID# 211493
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
DermAssociates /ID# 210838
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Great Lakes Research, Inc. /ID# 210192
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Somerset Skin Centre /ID# 211596
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Central Dermatology, PC /ID# 210301
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
AllCutis Research Inc /ID# 211429
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Medication Management, LLC /ID# 213217
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Oregon Medical Res Center PC /ID# 210334
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
University of Pittsburgh MC /ID# 210839
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Center for Clinical Studies /ID# 211565
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
Center for Clinical Studies /ID# 210362
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Suzanne Bruce and Associates /ID# 212210
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Austin Institute for Clinical Research /ID# 212203
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Premier Clinical Research /ID# 212209
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Froedtert Mem Lutheran Hosp /ID# 210194
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Learn more about this trial
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
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