Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis

Study Overview
=================
Brief Summary
-----------------
Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to severe psoriasis.

Official Title
-----------------
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Rising i.v. (Stage 1) and s.c. (Stage 2) Doses of BI 655066 in Male and Female Patients With Moderate to Severe Psoriasis (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: BI 655066 (very high i.v. dose)
* Drug: Placebo, i.v.
* Drug: BI 655066 (high s.c. dose)
* Drug: BI 655066 (low i.v. dose)
* Drug: BI 655066 (high medium i.v. dose)
* Drug: BI 655066 (very low i.v. dose)
* Drug: BI 655066 (low s.c. dose)
* Drug: BI 655066 (high i.v. dose)
* Drug: Placebo, s.c.
* Drug: BI 655066 (low medium i.v. dose)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female patients aged 18-75 years (inclusive) Chronic moderate to severe plaque psoriasis lasting =>6 months with involvement of Body Surface Area (BSA) =>10%, Psoriasis Area and Severity Index (PASI) =>12 and Static Physician Global Assessment (sPGA) score of moderate and above Body Mass Index (BMI) =>18.5 and <40 kg/m2 Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation Female patients must not be of childbearing potential (i.e., must be postmenopausal or surgically sterilized) and must have a negative pregnancy test at screening. Exclusion criteria: Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and Electrocardiogram (ECG)), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied (Psoriatic arthritis is not considered an exclusion.) Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders, chronic or relevant acute infections including hepatitis and tuberculosis (or a positive interferon-gamma release assay at screening) or history of orthostatic hypotension, fainting spells or blackouts, that in the investigator's judgement, could jeopardize the safe conduct of the study History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients Use of biologic agents or psoralen and ultraviolet A (PUVA) within 12 weeks prior to Visit 2, ultraviolet B (UVB) phototherapy and oral anti-psoriatic medications within 4 weeks prior to Visit 2, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to Visit 2 Use of ustekinumab within 24 weeks prior to Visit 2 Had a prior treatment of psoriasis with biologics with inadequate clinical response to therapy as assessed by a dermatologist or the investigator Intake of restricted medications or drugs considered likely to interfere with the safe conduct of the study Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 10 days prior to administration or during the trial Participation in another trial with an investigational drug within 4 weeks or 5 half-lives (whichever is greater) preceding Visit 2 History of alcohol abuse within last 12 months (intake of more than 30 g/day) History of drug abuse within last 12 months or positive drug screen at screening or Visit 2 Any blood donation or significant blood loss within 4 weeks prior to Visit 2 Unwilling or not capable to abstain from alcoholic beverages one day prior and two days after Visit 2 Excessive physical activities (within 1 week prior to Visit 2) Any laboratory value at the screening visit outside the reference range that is of clinical relevance based on physician investigator judgement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i.v. BI 655066<br>A subject to receive a single i.v. dose of BI 655066 | Drug: BI 655066 (very high i.v. dose)<br>* Single very high i.v. dose BI 655066<br>* Other names: risankizumab;Drug: BI 655066 (low i.v. dose)<br>* Single low i.v. dose BI 655066<br>* Other names: risankizumab;Drug: BI 655066 (high medium i.v. dose)<br>* Single high medium i.v. dose BI 655066<br>* Other names: risankizumab;Drug: BI 655066 (very low i.v. dose)<br>* Single very low i.v. dose BI 655066<br>* Other names: risankizumab;Drug: BI 655066 (high i.v. dose)<br>* Single high i.v. dose BI 655066<br>* Other names: risankizumab;Drug: BI 655066 (low medium i.v. dose)<br>* Single low medium i.v. dose BI 655066<br>* Other names: risankizumab;|
| Placebo Comparator: i.v. placebo<br>A subject to receive a single i.v. dose of placebo | Drug: Placebo, i.v.<br>* Single i.v. administration of placebo<br>|
| Experimental: s.c. BI 655066<br>A subject to receive a single s.c. dose of BI 655066 | Drug: BI 655066 (high s.c. dose)<br>* Single high s.c. dose BI 655066<br>* Other names: risankizumab;Drug: BI 655066 (low s.c. dose)<br>* Single low s.c. dose BI 655066<br>* Other names: risankizumab;|
| Placebo Comparator: s.c. placebo<br>A subject to receive a single s.c. dose of placebo | Drug: Placebo, s.c.<br>* Single s.c. administration of placebo<br>* Other names: risankizumab;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with good and satisfactory assessment of global tolerability by investigator |  | 24 weeks | 
| Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator |  | up to 1 week | 
| Number of participants with adverse events |  | up to 24 weeks | 
| Number of participants with clinically relevant findings in vital signs |  | up to 24 weeks | 
| Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results |  | up to 24 weeks | 
| Number of participants with significant changes from baseline laboratory measurements |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index (absolute score) |  | up to 24 weeks | 
| Percentage of participants with Static Physicians Global Assessment (clear and almost clear) |  | up to 24 weeks | 
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 24 weeks | 
| tmax (time from dosing to maximum measured concentration) |  | up to 24 weeks | 
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | 24 weeks | 
| Psoriasis Area and Severity Index (percentage change from baseline) |  | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ABBV-066, BI 655066, risankizumab