NCT04908475

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

A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Risankizumab	Subcutaneous injection
DRUG	Apremilast	Oral Tablets

Timeline

• Start date: 2021-06-09
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2021-06-01
• Last updated: 2024-04-30
• Results posted: 2024-04-30

Locations

54 sites across 5 countries: United States, Canada, Germany, Israel, Poland

Regulatory

• FDA-regulated drug study