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

Phase 1

Recruiting

• Conditions: Plaque Psoriasis; MedDRA version: 20.0Level: LLTClassification code: 10071117Term: Plaque psoriasis Class: 10040785; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-509738-20-00
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-22
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 336

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified