Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement
NCT ID: NCT04713592
Last Updated: 2024-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
174 participants
INTERVENTIONAL
2021-02-26
2023-04-20
Brief Summary
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Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world.
Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Placebo for Risankizumab
Subcutaneous (SC) Injection
Risankizumab
Subcutaneous (SC) Injection
Risankizumab
Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Risankizumab
Subcutaneous (SC) Injection
Interventions
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Placebo for Risankizumab
Subcutaneous (SC) Injection
Risankizumab
Subcutaneous (SC) Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles.
* Must be a candidate for systemic therapy as assessed by the investigator.
* Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.
Exclusion Criteria
* History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
* Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments.
* Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline.
* Prior exposure to risankizumab.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Advanced Research Associates - Glendale /ID# 219197
Glendale, Arizona, United States
Burke Pharmaceutical Research /ID# 223349
Hot Springs, Arkansas, United States
NW Arkansas Clinical Trials Center /ID# 231602
Rogers, Arkansas, United States
Dermatology Research Associates /ID# 219195
Los Angeles, California, United States
Integrative Skin Science and Research /ID# 219216
Sacramento, California, United States
Medderm Associates /ID# 219210
San Diego, California, United States
Colorado Center for Dermatology, PLLC /ID# 219223
Centennial, Colorado, United States
Skin Care Research - Hollywood /ID# 219184
Hollywood, Florida, United States
GSI Clinical Research, LLC /ID# 219175
Margate, Florida, United States
Savin Medical Group, LLC /ID# 227754
Miami Lakes, Florida, United States
Lenus Research & Medical Group /ID# 219202
Sweetwater, Florida, United States
Hamilton Research, LLC /ID# 219224
Alpharetta, Georgia, United States
Arlington Dermatology /ID# 219211
Rolling Meadows, Illinois, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220
Skokie, Illinois, United States
Dawes Fretzin, LLC /ID# 219219
Indianapolis, Indiana, United States
The Dermatology Center PSC - New Albany /ID# 219183
New Albany, Indiana, United States
Epiphany Dermatology of Kansas LLC /ID# 219208
Overland Park, Kansas, United States
Allcutis Research LLC /ID# 222272
Methuen, Massachusetts, United States
David Fivenson, MD, PLC /ID# 219180
Ann Arbor, Michigan, United States
Henry Ford Medical Center /ID# 219205
Detroit, Michigan, United States
Advanced Dermatology of the Midlands /ID# 219207
Omaha, Nebraska, United States
Psoriasis Treatment Center of Central New Jersey /ID# 219201
East Windsor, New Jersey, United States
Forest Hills Dermatology Group /ID# 219200
Kew Gardens, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 219206
New York, New York, United States
ClinOhio Research Services /ID# 222298
Columbus, Ohio, United States
University of Pittsburgh MC /ID# 219203
Pittsburgh, Pennsylvania, United States
Velocity Clinical Research-Providence /ID# 223350
East Greenwich, Rhode Island, United States
Palmetto Clinical Trial Services /ID# 222275
Fountain Inn, South Carolina, United States
Palmetto Clinical Trial Services /ID# 222299
Fountain Inn, South Carolina, United States
International Clinical Research - Tennessee LLC /ID# 220930
Murfreesboro, Tennessee, United States
Menter Dermatology Res Inst /ID# 219161
Dallas, Texas, United States
Center for Clinical Studies - Houston (Binz) /ID# 219221
Houston, Texas, United States
Advanced Clinical Research - Woseth Dermatology /ID# 224750
Salt Lake City, Utah, United States
Virginia Clinical Research, Inc. /ID# 219181
Norfolk, Virginia, United States
Beacon Dermatology Inc /ID# 220940
Calgary, Alberta, Canada
Dr. Chih-ho Hong Medical Inc. /ID# 220941
Surrey, British Columbia, Canada
Dr. Irina Turchin PC Inc. /ID# 220938
Fredericton, New Brunswick, Canada
NewLab Clinical Research Inc. /ID# 220934
St. John's, Newfoundland and Labrador, Canada
Dr. S.K. Siddha Medicine Professional Corporation /ID# 220936
Newmarket, Ontario, Canada
Research Toronto /ID# 220939
Toronto, Ontario, Canada
Innovaderm Research Inc. /ID# 222126
Montreal, Quebec, Canada
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 220935
Québec, Quebec, Canada
Dr. Samuel Sanchez PSC /ID# 218789
Caguas, , Puerto Rico
Alma M. Cruz Santana, MD-Private practice /ID# 218790
Carolina, , Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 218788
Rio Piedras, , Puerto Rico
Clinical Research Puerto Rico /ID# 218787
San Juan, , Puerto Rico
GCM Medical Group, PSC /ID# 218786
San Juan, , Puerto Rico
Hospital Universitario Basurto /ID# 220904
Bilbao, Vizcaya, Spain
Hospital Universitario de la Princesa /ID# 224911
Madrid, , Spain
Hospital Universitario Ramon y Cajal /ID# 220908
Madrid, , Spain
Hospital Regional Universitario de Malaga /ID# 220900
Málaga, , Spain
Hospital Universitario Virgen del Rocio /ID# 220907
Seville, , Spain
Hospital General Universitario de Valencia /ID# 220898
Valencia, , Spain
Hospital Universitario y Politecnico La Fe /ID# 220903
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa /ID# 222492
Zaragoza, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2020-000581-42
Identifier Type: -
Identifier Source: secondary_id
M15-994
Identifier Type: -
Identifier Source: org_study_id
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