A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
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
1 other identifier
interventional
157
2 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2019
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedStudy Start
First participant enrolled
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2020
CompletedResults Posted
Study results publicly available
March 16, 2021
CompletedMarch 16, 2021
February 1, 2021
9 months
March 13, 2019
February 19, 2021
February 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
At Week 16
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.
At Week 16
Secondary Outcomes (2)
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
At Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16
At Week 16
Other Outcomes (1)
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16
Baseline, Week 4, and Week 16
Study Arms (2)
Risankizumab
EXPERIMENTALSubcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
Placebo
PLACEBO COMPARATORSubcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
Interventions
Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously
Placebo solution in prefilled syringes, self-administered subcutaneously
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (43)
Total Skin and Beauty Derm Ctr /ID# 210366
Birmingham, Alabama, 35205, United States
Alliance Dermatology and MOHs /ID# 210645
Phoenix, Arizona, 85032, United States
Hull Dermatology, PA /ID# 210305
Rogers, Arkansas, 72758, United States
Anaheim Clinical Trials LLC /ID# 212559
Anaheim, California, 92801-2658, United States
Wallace Medical Group, Inc. /ID# 210403
Beverly Hills, California, 90211, United States
Dermatology Res. Assoc., CA /ID# 210402
Los Angeles, California, 90045, United States
Integrative Skin Science and Research /ID# 212551
Sacramento, California, 95815-4500, United States
Mosaic Dermatology /ID# 210780
Santa Monica, California, 90404, United States
Skin Care Research, LLC /ID# 210514
Boca Raton, Florida, 33486-2269, United States
ACCEL Research Sites /ID# 212709
DeLand, Florida, 32720, United States
Multi-Speciality Research Associates /ID# 211625
Lake City, Florida, 32055-8835, United States
GSI Clinical Research, LLC /ID# 210330
Margate, Florida, 33063, United States
Suncoast Clinical Research /ID# 210874
New Port Richey, Florida, 34652, United States
Ormond Medical Arts Pharmaceutical Research Center /ID# 212781
Ormond Beach, Florida, 32174-6302, United States
Progressive Medical Research /ID# 210877
Port Orange, Florida, 32127, United States
Precision Clinical Research /ID# 212921
Sunrise, Florida, 33351-7311, United States
Lenus Research & Medical Group /ID# 212584
Sweetwater, Florida, 33172, United States
Treasure Valley Dermatology /ID# 212707
Boise, Idaho, 83713-0997, United States
Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562
Normal, Illinois, 61761, United States
The Indiana Clinical Trials Center /ID# 210205
Plainfield, Indiana, 46168, United States
Forefront Dermatology /ID# 210520
Louisville, Kentucky, 40202-2862, United States
DS Research /ID# 210272
Louisville, Kentucky, 40241-6162, United States
David Fivenson, MD, PLC /ID# 210193
Ann Arbor, Michigan, 48103, United States
Clarkston Skin Research /ID# 210197
Clarkston, Michigan, 48346, United States
Henry Ford Medical Center /ID# 211598
Detroit, Michigan, 48202-3046, United States
Cleaver Dermatology /ID# 210300
Kirksville, Missouri, 63501-5362, United States
Advanced Dermatology of the Midlands /ID# 212763
Omaha, Nebraska, 68144-1105, United States
Skin Specialists, PC /ID# 211490
Omaha, Nebraska, 68144, United States
Psoriasis Treatment Ctr NJ /ID# 210837
East Windsor, New Jersey, 08520, United States
Skin Laser and Surgery Specialists of NY and NJ /ID# 210208
Hackensack, New Jersey, 07601-1997, United States
DermResearchCenter of NY, Inc. /ID# 210652
Stony Brook, New York, 11790, United States
WDC Cosmetic and Research, PLLC /ID# 210372
Wilmington, North Carolina, 28403, United States
Lynn Health Science Institute (LHSI) /ID# 213216
Oklahoma City, Oklahoma, 73112, United States
Clinical Partners, LLC /ID# 210642
Johnston, Rhode Island, 02919, United States
Palmetto Clinical Trial Services /ID# 210368
Fountain Inn, South Carolina, 29644-1928, United States
Coastal Carolina Research Ctr /ID# 213069
Mt. Pleasant, South Carolina, 29464, United States
Arlington Research Center, Inc /ID# 210344
Arlington, Texas, 76011, United States
Center for Clinical Studies - Houston (Binz) /ID# 210361
Houston, Texas, 77004-8097, United States
Progressive Clinical Research /ID# 210359
San Antonio, Texas, 78229, United States
Acclaim Dermatology /ID# 212252
Sugar Land, Texas, 77479-2645, United States
Dr. Samuel Sanchez, PSC /ID# 211142
Caguas, 00727, Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 212445
Rio Piedras, 00935, Puerto Rico
Clinical Research Puerto Rico /ID# 211144
San Juan, 0090, Puerto Rico
Related Publications (1)
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.
PMID: 33947295DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2019
First Posted
March 14, 2019
Study Start
May 13, 2019
Primary Completion
February 20, 2020
Study Completion
July 15, 2020
Last Updated
March 16, 2021
Results First Posted
March 16, 2021
Record last verified: 2021-02
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.
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.