Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
NCT ID: NCT04908475
Last Updated: 2024-04-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
352 participants
INTERVENTIONAL
2021-06-09
2023-04-20
Brief Summary
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Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally.
The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab.
There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and 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
SINGLE
Study Groups
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Risankizumab
Risankizumab 150 mg as a single subcutaneous (SC) injection at at Baseline (Day 1) and Week 4 (Period A) and at Weeks 16, 28, and 40 (Period B).
Risankizumab
Subcutaneous injection
Apremilast
Participants receive apremilast 30 mg orally twice daily (BID) in Period A and re-randomized to receive either risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32 in Period B or apremilast 30 mg orally BID from Week 16 up to Week 52 in Period B. For those taking apremilast in Period B, non-responders at Week 28 and Week 40 will be offered to receive risankizumab as rescue medication.
Risankizumab
Subcutaneous injection
Apremilast
Oral Tablets
Interventions
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Risankizumab
Subcutaneous injection
Apremilast
Oral Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Surface Area (BSA) \>= 10% and \<= 15%; and
* Psoriasis Area and Severity Index (PASI) \>= 12; and
* Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4).
Exclusion Criteria
* History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
* History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
* Prior exposure to risankizumab or apremilast.
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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Total Skin and Beauty Dermatology Center /ID# 233793
Birmingham, Alabama, United States
Advanced Research Associates - Glendale /ID# 229266
Glendale, Arizona, United States
Alliance Dermatology and MOHs Center, PC /ID# 229224
Phoenix, Arizona, United States
UC Davis Health /ID# 229133
Sacramento, California, United States
Florida Academic Centers Research and Education /ID# 229235
Coral Gables, Florida, United States
Olympian Clinical Research - Largo /ID# 233792
Largo, Florida, United States
Renstar Medical Research /ID# 228946
Ocala, Florida, United States
ForCare Clinical Research /ID# 229135
Tampa, Florida, United States
Arlington Dermatology /ID# 228945
Rolling Meadows, Illinois, United States
Dawes Fretzin, LLC /ID# 229010
Indianapolis, Indiana, United States
Epiphany Dermatology of Kansas LLC /ID# 229221
Overland Park, Kansas, United States
DermAssociates, LLC /ID# 229016
Rockville, Maryland, United States
Michigan Center for Research Company /ID# 229136
Clarkston, Michigan, United States
Henry Ford Medical Center /ID# 229215
Detroit, Michigan, United States
MediSearch Clinical Trials /ID# 229269
Saint Joseph, Missouri, United States
Physician Research Collaboration, LLC /ID# 229225
Lincoln, Nebraska, United States
Advanced Dermatology of the Midlands /ID# 229009
Omaha, Nebraska, United States
Psoriasis Treatment Center of Central New Jersey /ID# 228943
East Windsor, New Jersey, United States
University Hospitals Case Medical Center /ID# 229240
Cleveland, Ohio, United States
Wright State Physicians - Fairborn /ID# 230051
Fairborn, Ohio, United States
Oregon Dermatology and Research Center /ID# 233462
Portland, Oregon, United States
Arlington Research Center, Inc /ID# 229264
Arlington, Texas, United States
Bellaire Dermatology Associates /ID# 230118
Bellaire, Texas, United States
Center for Clinical Studies - Houston (Binz) /ID# 229263
Houston, Texas, United States
Center for Clinical Studies - Houston (Binz) /ID# 229272
Houston, Texas, United States
Premier Clinical Research /ID# 229220
Spokane, Washington, United States
Beacon Dermatology Inc /ID# 230121
Calgary, Alberta, Canada
Dr. Chih-ho Hong Medical Inc. /ID# 230337
Surrey, British Columbia, Canada
Enverus Medical Research /ID# 230480
Surrey, British Columbia, Canada
Karma Clinical Trials /ID# 230339
St. John's, Newfoundland and Labrador, Canada
Dermatrials Research /ID# 230119
Hamilton, Ontario, Canada
Dr. S.K. Siddha Medicine Professional Corporation /ID# 230416
Newmarket, Ontario, Canada
K. Papp Clinical Research /ID# 230336
Waterloo, Ontario, Canada
Innovaderm Research Inc. /ID# 230334
Montreal, Quebec, Canada
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 230478
Québec, Quebec, Canada
Universitaetsklinikum Erlangen /ID# 229433
Erlangen, Bavaria, Germany
Universitaetsklinikum Frankfurt /ID# 229431
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Muenster /ID# 229432
Munster, Lower Saxony, Germany
DermaKiel Allergie und Haut Centrum /ID# 229630
Kiel, Schleswig-Holstein, Germany
Fachklinik Bad Bentheim /ID# 231504
Bad Bentheim, , Germany
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 230245
Bochum, , Germany
SRH Wald-Klinikum Gera /ID# 229445
Gera, , Germany
MENSINGDERMA research GmbH /ID# 229435
Hamburg, , Germany
Dermatologische Gemeinschaftspraxis Mahlow /ID# 229434
Mahlow, , Germany
Rambam Health Care Campus /ID# 229620
Haifa, H_efa, Israel
Rabin Medical Center /ID# 229074
Haifa, H_efa, Israel
HaEmek Medical Center /ID# 231901
Afula, Southern District, Israel
The Chaim Sheba Medical Center /ID# 229075
Ramat Gan, Tel Aviv, Israel
High-Med Przychodnia Specjalistyczna /ID# 229023
Warsaw, Masovian Voivodeship, Poland
Royalderm Agnieszka Nawrocka /ID# 228973
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 229022
Rzeszów, Podkarpackie Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229053
Gdansk, Pomeranian Voivodeship, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 228971
Elblag, Warmian-Masurian Voivodeship, Poland
Dermed Centrum Medyczne Sp. z o.o /ID# 229051
Lodz, Łódź Voivodeship, Poland
Countries
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References
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Stein Gold LF, Bagel J, Tyring SK, Hong HC, Pavlovsky L, Vender R, Pinter A, Reich A, Drogaris L, Wu T, Patel M, Soliman AM, Photowala H, Stakias V, Richter S, Papp KA. Comparison of risankizumab and apremilast for the treatment of adults with moderate plaque psoriasis eligible for systemic therapy: results from a randomized, open-label, assessor-blinded phase IV study (IMMpulse). Br J Dermatol. 2023 Oct 25;189(5):540-552. doi: 10.1093/bjd/ljad252.
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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2020-005512-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M20-326
Identifier Type: -
Identifier Source: org_study_id
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