Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

- 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).

Exclusion Criteria:

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 is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

352

Study ID:

NCT04908475

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 53 Locations for this study

See Locations Near You

Total Skin and Beauty Dermatology Center /ID# 233793
Birmingham Alabama, 35205, United States
Advanced Research Associates - Glendale /ID# 229266
Glendale Arizona, 85308, United States
Alliance Dermatology and MOHs Center, PC /ID# 229224
Phoenix Arizona, 85032, United States
UC Davis Health /ID# 229133
Sacramento California, 95816, United States
Florida Academic Centers Research and Education /ID# 229235
Coral Gables Florida, 33134, United States
Olympian Clinical Research - Largo /ID# 233792
Largo Florida, 33770, United States
Renstar Medical Research /ID# 228946
Ocala Florida, 34470, United States
ForCare Clinical Research /ID# 229135
Tampa Florida, 33613, United States
Arlington Dermatology /ID# 228945
Rolling Meadows Illinois, 60008, United States
Dawes Fretzin, LLC /ID# 229010
Indianapolis Indiana, 46256, United States
Epiphany Dermatology of Kansas LLC /ID# 229221
Overland Park Kansas, 66210, United States
DermAssociates, LLC /ID# 229016
Rockville Maryland, 20850, United States
Michigan Center for Research Company /ID# 229136
Clarkston Michigan, 48346, United States
Henry Ford Medical Center /ID# 229215
Detroit Michigan, 48202, United States
MediSearch Clinical Trials /ID# 229269
Saint Joseph Missouri, 64506, United States
Physician Research Collaboration, LLC /ID# 229225
Lincoln Nebraska, 68516, United States
Advanced Dermatology of the Midlands /ID# 229009
Omaha Nebraska, 68144, United States
Psoriasis Treatment Center of Central New Jersey /ID# 228943
East Windsor New Jersey, 08520, United States
University Hospitals Case Medical Center /ID# 229240
Cleveland Ohio, 44106, United States
Wright State Physicians - Fairborn /ID# 230051
Fairborn Ohio, 45324, United States
Oregon Dermatology and Research Center /ID# 233462
Portland Oregon, 97210, United States
Arlington Research Center, Inc /ID# 229264
Arlington Texas, 76011, United States
Bellaire Dermatology Associates /ID# 230118
Bellaire Texas, 77401, United States
Center for Clinical Studies - Houston (Binz) /ID# 229263
Houston Texas, 77004, United States
Center for Clinical Studies - Houston (Binz) /ID# 229272
Houston Texas, 77004, United States
Premier Clinical Research /ID# 229220
Spokane Washington, 99202, United States
Beacon Dermatology Inc /ID# 230121
Calgary Alberta, T3E 0, Canada
Dr. Chih-ho Hong Medical Inc. /ID# 230337
Surrey British Columbia, V3R 6, Canada
Enverus Medical Research /ID# 230480
Surrey British Columbia, V3V 0, Canada
Karma Clinical Trials /ID# 230339
St. John's Newfoundland and Labrador, A1A 4, Canada
Dermatrials Research /ID# 230119
Hamilton Ontario, L8N 1, Canada
Dr. S.K. Siddha Medicine Professional Corporation /ID# 230416
Newmarket Ontario, L3Y 5, Canada
K. Papp Clinical Research /ID# 230336
Waterloo Ontario, N2J 1, Canada
Innovaderm Research Inc. /ID# 230334
Montréal Quebec, H2X 2, Canada
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 230478
Québec Quebec, G1V 4, Canada
Universitaetsklinikum Erlangen /ID# 229433
Erlangen Bayern, 91054, Germany
Universitaetsklinikum Frankfurt /ID# 229431
Frankfurt am Main Hessen, 60590, Germany
Universitaetsklinikum Muenster /ID# 229432
Munster Niedersachsen, 48149, Germany
DermaKiel Allergie und Haut Centrum /ID# 229630
Kiel Schleswig-Holstein, 24148, Germany
Fachklinik Bad Bentheim /ID# 231504
Bad Bentheim , 48455, Germany
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 230245
Bochum , 44793, Germany
SRH Wald-Klinikum Gera /ID# 229445
Gera , 07548, Germany
MENSINGDERMA research GmbH /ID# 229435
Hamburg , 22391, Germany
Dermatologische Gemeinschaftspraxis Mahlow /ID# 229434
Mahlow , 15831, Germany
Rambam Health Care Campus /ID# 229620
Haifa H_efa, 31096, Israel
Rabin Medical Center /ID# 229074
Haifa H_efa, 49414, Israel
HaEmek Medical Center /ID# 231901
Afula HaDarom, 18341, Israel
The Chaim Sheba Medical Center /ID# 229075
Ramat Gan Tel-Aviv, 52656, Israel
Dermed Centrum Medyczne Sp. z o.o /ID# 229051
Lodz Lodzkie, 90-26, Poland
High-Med Przychodnia Specjalistyczna /ID# 229023
Warszawa Mazowieckie, 01-81, Poland
Royalderm Agnieszka Nawrocka /ID# 228973
Warszawa Mazowieckie, 02-96, Poland
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 229022
Rzeszow Podkarpackie, 35-05, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229053
Gdansk Pomorskie, 80-54, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 228971
Elblag Warminsko-mazurskie, 82-30, Poland

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

352

Study ID:

NCT04908475

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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