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.
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.
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There are 53 Locations for this study
Birmingham Alabama, 35205, United States
Glendale Arizona, 85308, United States
Phoenix Arizona, 85032, United States
Sacramento California, 95816, United States
Coral Gables Florida, 33134, United States
Largo Florida, 33770, United States
Ocala Florida, 34470, United States
Tampa Florida, 33613, United States
Rolling Meadows Illinois, 60008, United States
Indianapolis Indiana, 46256, United States
Overland Park Kansas, 66210, United States
Rockville Maryland, 20850, United States
Clarkston Michigan, 48346, United States
Detroit Michigan, 48202, United States
Saint Joseph Missouri, 64506, United States
Lincoln Nebraska, 68516, United States
Omaha Nebraska, 68144, United States
East Windsor New Jersey, 08520, United States
Cleveland Ohio, 44106, United States
Fairborn Ohio, 45324, United States
Portland Oregon, 97210, United States
Arlington Texas, 76011, United States
Bellaire Texas, 77401, United States
Houston Texas, 77004, United States
Houston Texas, 77004, United States
Spokane Washington, 99202, United States
Calgary Alberta, T3E 0, Canada
Surrey British Columbia, V3R 6, Canada
Surrey British Columbia, V3V 0, Canada
St. John's Newfoundland and Labrador, A1A 4, Canada
Hamilton Ontario, L8N 1, Canada
Newmarket Ontario, L3Y 5, Canada
Waterloo Ontario, N2J 1, Canada
Montréal Quebec, H2X 2, Canada
Québec Quebec, G1V 4, Canada
Erlangen Bayern, 91054, Germany
Frankfurt am Main Hessen, 60590, Germany
Munster Niedersachsen, 48149, Germany
Kiel Schleswig-Holstein, 24148, Germany
Bad Bentheim , 48455, Germany
Bochum , 44793, Germany
Gera , 07548, Germany
Hamburg , 22391, Germany
Mahlow , 15831, Germany
Haifa H_efa, 31096, Israel
Haifa H_efa, 49414, Israel
Afula HaDarom, 18341, Israel
Ramat Gan Tel-Aviv, 52656, Israel
Lodz Lodzkie, 90-26, Poland
Warszawa Mazowieckie, 01-81, Poland
Warszawa Mazowieckie, 02-96, Poland
Rzeszow Podkarpackie, 35-05, Poland
Gdansk Pomorskie, 80-54, Poland
Elblag Warminsko-mazurskie, 82-30, Poland
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