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

Brief 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.

Interventional study

Status:
Active, not recruiting
Conditions:
Psoriasis
Enrollment:
351 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M20-326
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

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.

All the cities where the clinical studies are located

Calgary - T3E 0B2
Surrey - V3R 6A7
Surrey - V3V 0C6
St. John's - A1A 4Y3
Halifax - B3H 1Z2
Hamilton - L8N 1Y2
Newmarket - L3Y 5G8
Waterloo - N2J 1C4
Montréal - H2X 2V1

Alberta

British Columbia

Newfoundland and Labrador

Nova Scotia