BI 655066/ABBV-066 (risankizumab) compared to placebo andactive comparator (ustekinumab) in patients with moderate tosevere chronic plaque psoriasis
- Conditions
- PsoriasisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-005117-23-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
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
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
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this trial is to assess the efficacy and safety of BI 655066 compared to ustekinumab and placebo in patients with moderate to severe chronic plaque psoriasis.;Secondary Objective: Additionally, this trial will assess PK and the emergence of anti-drug antibodies, as well as the influence of study treatment on disease specific biomarkers, psoriatic arthritis, and metabolic risk factors.;Primary end point(s): • Achievement of = 90% reduction from baseline PASI score (PASI 90) at Week 16<br>• Achievement of a sPGA score of clear or almost clear at Week 16<br>;Timepoint(s) of evaluation of this end point: 16 weeks from first trial medication
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Achievement of = 75% reduction from baseline PASI score (PASI 75) at Week 12<br>• Achievement of a sPGA score of clear or almost clear at Week 12 <br>• Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 16<br>• Achievement of = 90% reduction from baseline PASI score (PASI 90) at Week 52<br>• Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 52<br>• Change from baseline in psoriasis symptoms evaluated using the total score on the PSS at week 16<br>• Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16<br>• Achievement of total score on the PSS of 0 at week 16<br>;Timepoint(s) of evaluation of this end point: 1: 12 weeks from first trial medication<br><br>2: 16 weeks from first trial medication<br><br>3: 52 weeks from first trial medication<br>