BI 655066/ABBV-066 (risankizumab) compared to placebo and active comparator (ustekinumab) in patients with moderate to severe chronic plaque psoriasis

Phase 1

• Conditions: 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: EUCTR2014-005117-23-CZ
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-12
• Last Update Posted: 6 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Male or female patients with age = 18 years at screening.

Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.

Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):
-Have an involved body surface area (BSA) = 10% and
-Have a Psoriasis Area and Severity Index (PASI) score = 12 and
- Have a static Physician Global Assessment (sPGA) score of = 3.

Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator.

Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 425
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Patients with
a. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
b. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
c. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator¿s judgment

Previous exposure to BI 655066

Previous exposure to ustekinumab (Stelara®)

Study & Design

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