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

Completed · Phase 4

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT04908475

Run by

AbbVie

People needed

352

Starts

2021-06-09

Expected to finish

2023-04-20

Last updated by the study team

2024-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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
• Total Skin and Beauty Dermatology Center /ID# 233793 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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