Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate Plaque Psoriasis who are Candidates for Systemic Therapy

Phase 1

• Conditions: Moderate plaque psoriasis.; MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-005512-21-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-07
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Candidates for systemic therapy with moderate 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 >= 12%; and
- Static Physician Global Assessment = 3 (moderate) based on a 5-point scale (0 to 4)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 285
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Participant has other form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
2. History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
3. 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).
4. Prior exposure to risankizumab or apremilast.

Study & Design

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