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

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Risankizumab — DRUG
  Subcutaneous injection
• Apremilast — DRUG
  Oral Tablets

Study Details

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 Dates

Start date

Jun 9, 2021

Status verified

Apr 2024

Primary completion

Apr 20, 2023

Completion

Apr 20, 2023

Study Design

Enrollment

352 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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).
• Experimental: 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.

Primary Outcome Measure

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) [ Time Frame: Week 16 ]

Locations (26)

Find similar trials in Birmingham, AL

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