2023-509738-20-00RecruitingPhase 4
A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded-Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects with Moderate Plaque Psoriasis who are Candidates for Systemic Therapy
AbbVie Deutschland GmbH & Co. KG29 sites in 7 countries150 target enrollmentStarted: July 3, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 29
- Primary Endpoint
- Period A: Achievement of PASI 100 at Week 16
Study Overview
Brief Summary
The primary efficacy objective in Period A is to demonstrate superiority of risankizumab to deucravacitinib in achieving a) PASI 90 (defined as ≥ 90% reduction from Baseline in PASI) and b) sPGA 0 or 1 with at least 2-grade improvement from Baseline after 16 weeks of treatment with risankizumab when compared to deucravacitinib.
The primary efficacy objective in Period B is to demonstrate superiority of switching to risankizumab to continuing deucravacitinib in achieving PASI 90 at Week 52 among subjects who fail to achieve PASI 90 at 16 weeks of deucravacitinib treatment.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Treatment Period - Period B (Week 16 to Week 52)
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female adults (18 years or above) who are candidates for systemic therapy with a diagnosis of moderate chronic plaque PsO (with or without PsA) for at least 6 months prior to Baseline (Day 1), who have not previously been treated with biologics and at Screening and Baseline have been defined as: • BSA ≥ 10% and ≤ 15%; • PASI ≥ 12; and • sPGA = 3 (moderate) based on a 5-point scale (0 to 4)
Exclusion Criteria
- •Employees of the sponsor and/or study sites and their family members may not be enrolled in this study.
- •Subjects with evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Human immunodeficiency virus (HIV), Active TB, Active systemic infection/Clinically important infection during the last 2 weeks prior to Baseline visit as assessed by the investigator.
- •Subjects with any of the following medical diseases or disorders: recent (within past 6 months) cerebrovascular accident or myocardial infarction; history of an organ transplant which requires continued immunosuppression; active or suspected malignancy or history of any malignancy within the last 5 years; prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent and randomization, hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
- •Subjects with concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study.
- •Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug.
- •Subjects with any form of PsO other than chronic plaque PsO.
- •Subjects with a history of current drug-induced PsO or a drug-induced exacerbation of pre-existing PsO.
- •Subjects with a history of active ongoing inflammatory skin diseases other than PsO.
- •Subjects with a history of severe renal insufficiency defined as creatinine clearance < 30 mL/min and/or requiring hemodialysis or peritoneal dialysis.
- •Subjects with a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
- •Subjects with a history of an allergic reaction or significant sensitivity to constituents of the study drugs (and its excipients) and/or other products in the same class.
- •Subjects who have had major surgery performed within 12 weeks prior to randomization or planned during the conduct of the study.
Outcomes
Primary Outcomes
Period A: Achievement of PASI 100 at Week 16
Period A: Achievement of PASI 100 at Week 16
Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16
Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16
Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 90 at Week 52
Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 90 at Week 52
Secondary Outcomes
- Period A: Achievement of PASI 100 at Week 16
- Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16
- Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 100 at Week 52, among subjects
- Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 52, among subjects
Investigators
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
Study Sites (29)
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