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
- Registration Number
- NCT04908475
- Lead Sponsor
- AbbVie
- Brief Summary
Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in disease symptoms will be monitored.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
- Candidates for systemic therapy with moderate chronic plaque psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as:
- 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).
- Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risankizumab 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). Apremilast 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. Apremilast Risankizumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A) Week 16 The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) Week 52 The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) Week 16 The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) Week 16 The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) Week 52 The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).
Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) Week 52 The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.
Trial Locations
- Locations (54)
Epiphany Dermatology of Kansas LLC /ID# 229221
🇺🇸Overland Park, Kansas, United States
Center for Clinical Studies - Houston (Binz) /ID# 229272
🇺🇸Houston, Texas, United States
UC Davis Health /ID# 229133
🇺🇸Sacramento, California, United States
Renstar Medical Research /ID# 228946
🇺🇸Ocala, Florida, 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
Arlington Dermatology /ID# 228945
🇺🇸Rolling Meadows, Illinois, United States
Michigan Center for Research Company /ID# 229136
🇺🇸Clarkston, Michigan, United States
DermAssociates, LLC /ID# 229016
🇺🇸Rockville, Maryland, United States
MediSearch Clinical Trials /ID# 229269
🇺🇸Saint Joseph, Missouri, United States
Physician Research Collaboration, LLC /ID# 229225
🇺🇸Lincoln, 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
Bellaire Dermatology Associates /ID# 230118
🇺🇸Bellaire, Texas, United States
Arlington Research Center, Inc /ID# 229264
🇺🇸Arlington, Texas, United States
Premier Clinical Research /ID# 229220
🇺🇸Spokane, Washington, United States
Center for Clinical Studies - Houston (Binz) /ID# 229263
🇺🇸Houston, Texas, United States
Dermatrials Research /ID# 230119
🇨🇦Hamilton, Ontario, Canada
Dr. S.K. Siddha Medicine Professional Corporation /ID# 230416
🇨🇦Newmarket, Ontario, Canada
Innovaderm Research Inc. /ID# 230334
🇨🇦Montréal, Quebec, Canada
Universitaetsklinikum Erlangen /ID# 229433
🇩🇪Erlangen, Bayern, Germany
Universitaetsklinikum Frankfurt /ID# 229431
🇩🇪Frankfurt am Main, Hessen, Germany
Universitaetsklinikum Muenster /ID# 229432
🇩🇪Munster, Niedersachsen, Germany
Fachklinik Bad Bentheim /ID# 231504
🇩🇪Bad Bentheim, Germany
MENSINGDERMA research GmbH /ID# 229435
🇩🇪Hamburg, Germany
SRH Wald-Klinikum Gera /ID# 229445
🇩🇪Gera, Germany
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 230245
🇩🇪Bochum, Germany
Dermatologische Gemeinschaftspraxis Mahlow /ID# 229434
🇩🇪Mahlow, Germany
Rambam Health Care Campus /ID# 229620
🇮🇱Haifa, H_efa, Israel
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229053
🇵🇱Gdansk, Pomorskie, Poland
DermaKiel Allergie und Haut Centrum /ID# 229630
🇩🇪Kiel, Schleswig-Holstein, Germany
Advanced Research Associates - Glendale /ID# 229266
🇺🇸Glendale, Arizona, United States
High-Med Przychodnia Specjalistyczna /ID# 229023
🇵🇱Warszawa, Mazowieckie, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 228971
🇵🇱Elblag, Warminsko-mazurskie, Poland
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 230478
🇨🇦Québec, Quebec, Canada
Rabin Medical Center /ID# 229074
🇮🇱Haifa, H_efa, Israel
HaEmek Medical Center /ID# 231901
🇮🇱Afula, HaDarom, Israel
The Chaim Sheba Medical Center /ID# 229075
🇮🇱Ramat Gan, Tel-Aviv, Israel
Dermed Centrum Medyczne Sp. z o.o /ID# 229051
🇵🇱Lodz, Lodzkie, Poland
Royalderm Agnieszka Nawrocka /ID# 228973
🇵🇱Warszawa, Mazowieckie, Poland
Dr. Chih-ho Hong Medical Inc. /ID# 230337
🇨🇦Surrey, British Columbia, Canada
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 229022
🇵🇱Rzeszow, Podkarpackie, Poland
Alliance Dermatology and MOHs Center, PC /ID# 229224
🇺🇸Phoenix, Arizona, United States
Dawes Fretzin, LLC /ID# 229010
🇺🇸Indianapolis, Indiana, United States
Henry Ford Medical Center /ID# 229215
🇺🇸Detroit, Michigan, United States
K. Papp Clinical Research /ID# 230336
🇨🇦Waterloo, Ontario, Canada
Total Skin and Beauty Dermatology Center /ID# 233793
🇺🇸Birmingham, Alabama, United States
Oregon Dermatology and Research Center /ID# 233462
🇺🇸Portland, Oregon, United States
Advanced Dermatology of the Midlands /ID# 229009
🇺🇸Omaha, Nebraska, United States
ForCare Clinical Research /ID# 229135
🇺🇸Tampa, Florida, United States
Beacon Dermatology Inc /ID# 230121
🇨🇦Calgary, Alberta, Canada
Enverus Medical Research /ID# 230480
🇨🇦Surrey, British Columbia, Canada
Karma Clinical Trials /ID# 230339
🇨🇦St. John's, Newfoundland and Labrador, Canada