BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:12/7/2017
Start Date:February 2016
End Date:August 2017

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BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis (UltIMMa-1)

This is a randomized double blind, double dummy, placebo and active comparator controlled,
parallel design study that is being performed to assess the safety and efficacy of BI
655066/ABBV-066 (risankizumab) to support registration for the treatment of moderate to
severe chronic plaque psoriasis in adult patients.


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.

Exclusion criteria:

- Patients with:

1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)

2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta
blockers, calcium channel blockers, or lithium)

3. 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®).
We found this trial at
29
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