Back to resultsA Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risankizumab
Placebo solution for risankizumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Risankizumab, Psoriasis, 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 greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 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
- Total Skin and Beauty Derm Ctr /ID# 210366
- Alliance Dermatology and MOHs /ID# 210645
- Hull Dermatology, PA /ID# 210305
- Anaheim Clinical Trials LLC /ID# 212559
- Wallace Medical Group, Inc. /ID# 210403
- Dermatology Res. Assoc., CA /ID# 210402
- Integrative Skin Science and Research /ID# 212551
- Mosaic Dermatology /ID# 210780
- Skin Care Research, LLC /ID# 210514
- ACCEL Research Sites /ID# 212709
- Multi-Speciality Research Associates /ID# 211625
- GSI Clinical Research, LLC /ID# 210330
- Suncoast Clinical Research /ID# 210874
- Ormond Medical Arts Pharmaceutical Research Center /ID# 212781
- Progressive Medical Research /ID# 210877
- Precision Clinical Research /ID# 212921
- Lenus Research & Medical Group /ID# 212584
- Treasure Valley Dermatology /ID# 212707
- Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562
- The Indiana Clinical Trials Center /ID# 210205
- Forefront Dermatology /ID# 210520
- DS Research /ID# 210272
- David Fivenson, MD, PLC /ID# 210193
- Clarkston Skin Research /ID# 210197
- Henry Ford Medical Center /ID# 211598
- Cleaver Dermatology /ID# 210300
- Advanced Dermatology of the Midlands /ID# 212763
- Skin Specialists, PC /ID# 211490
- Psoriasis Treatment Ctr NJ /ID# 210837
- Skin Laser and Surgery Specialists of NY and NJ /ID# 210208
- DermResearchCenter of NY, Inc. /ID# 210652
- WDC Cosmetic and Research, PLLC /ID# 210372
- Lynn Health Science Institute (LHSI) /ID# 213216
- Clinical Partners, LLC /ID# 210642
- Palmetto Clinical Trial Services /ID# 210368
- Coastal Carolina Research Ctr /ID# 213069
- Arlington Research Center, Inc /ID# 210344
- Center for Clinical Studies - Houston (Binz) /ID# 210361
- Progressive Clinical Research /ID# 210359
- Acclaim Dermatology /ID# 212252
- Dr. Samuel Sanchez, PSC /ID# 211142
- Pan American Center for Oncology Trials, LLC /ID# 212445
- Clinical Research Puerto Rico /ID# 211144
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Risankizumab
Placebo
Arm Description
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
Outcomes
Primary Outcome Measures
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. 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 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.
Secondary Outcome Measures
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. PASI100 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 Static Physician Global Assessment (sPGA) of 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03875482
Brief Title
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
July 15, 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
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.
Detailed Description
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 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
Risankizumab, Psoriasis, Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risankizumab
Arm Type
Experimental
Arm Description
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
ABBV-066, BI 655066
Intervention Description
Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo solution for risankizumab
Intervention Description
Placebo solution in prefilled syringes, self-administered subcutaneously
Primary Outcome Measure Information:
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. 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 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
Secondary Outcome Measure Information:
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. PASI100 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 Static Physician Global Assessment (sPGA) of 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
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 greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 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
Total Skin and Beauty Derm Ctr /ID# 210366
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Alliance Dermatology and MOHs /ID# 210645
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Hull Dermatology, PA /ID# 210305
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Anaheim Clinical Trials LLC /ID# 212559
City
Anaheim
State/Province
California
ZIP/Postal Code
92801-2658
Country
United States
Facility Name
Wallace Medical Group, Inc. /ID# 210403
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Dermatology Res. Assoc., CA /ID# 210402
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Integrative Skin Science and Research /ID# 212551
City
Sacramento
State/Province
California
ZIP/Postal Code
95815-4500
Country
United States
Facility Name
Mosaic Dermatology /ID# 210780
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Skin Care Research, LLC /ID# 210514
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486-2269
Country
United States
Facility Name
ACCEL Research Sites /ID# 212709
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Multi-Speciality Research Associates /ID# 211625
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055-8835
Country
United States
Facility Name
GSI Clinical Research, LLC /ID# 210330
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Suncoast Clinical Research /ID# 210874
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Ormond Medical Arts Pharmaceutical Research Center /ID# 212781
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174-6302
Country
United States
Facility Name
Progressive Medical Research /ID# 210877
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Precision Clinical Research /ID# 212921
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351-7311
Country
United States
Facility Name
Lenus Research & Medical Group /ID# 212584
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Treasure Valley Dermatology /ID# 212707
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713-0997
Country
United States
Facility Name
Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
The Indiana Clinical Trials Center /ID# 210205
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Forefront Dermatology /ID# 210520
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-2862
Country
United States
Facility Name
DS Research /ID# 210272
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241-6162
Country
United States
Facility Name
David Fivenson, MD, PLC /ID# 210193
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Clarkston Skin Research /ID# 210197
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Henry Ford Medical Center /ID# 211598
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-3046
Country
United States
Facility Name
Cleaver Dermatology /ID# 210300
City
Kirksville
State/Province
Missouri
ZIP/Postal Code
63501-5362
Country
United States
Facility Name
Advanced Dermatology of the Midlands /ID# 212763
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144-1105
Country
United States
Facility Name
Skin Specialists, PC /ID# 211490
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Psoriasis Treatment Ctr NJ /ID# 210837
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Skin Laser and Surgery Specialists of NY and NJ /ID# 210208
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601-1997
Country
United States
Facility Name
DermResearchCenter of NY, Inc. /ID# 210652
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
WDC Cosmetic and Research, PLLC /ID# 210372
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Lynn Health Science Institute (LHSI) /ID# 213216
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Clinical Partners, LLC /ID# 210642
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Palmetto Clinical Trial Services /ID# 210368
City
Fountain Inn
State/Province
South Carolina
ZIP/Postal Code
29644-1928
Country
United States
Facility Name
Coastal Carolina Research Ctr /ID# 213069
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Arlington Research Center, Inc /ID# 210344
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Center for Clinical Studies - Houston (Binz) /ID# 210361
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-8097
Country
United States
Facility Name
Progressive Clinical Research /ID# 210359
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Acclaim Dermatology /ID# 212252
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479-2645
Country
United States
Facility Name
Dr. Samuel Sanchez, PSC /ID# 211142
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Facility Name
Pan American Center for Oncology Trials, LLC /ID# 212445
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico /ID# 211144
City
San Juan
ZIP/Postal Code
0090
Country
Puerto Rico
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
Citations:
PubMed Identifier
33947295
Citation
Blauvelt A, Gordon KB, Lee P, Bagel J, Sofen H, Lockshin B, Soliman AM, Geng Z, Zhan T, Alperovich G, Stein Gold L. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5.
Results Reference
derived
Links:
URL
http://rxabbvie.com
Description
Related Info.
Learn more about this trial
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
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