Clinical trial NCT01577550: Single Rising Dose Study of BI 655066 in Patients With Moderate and 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: ABBV-066
BI 655066
risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2012-04-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to severe psoriasis.


Eligibility criteria: Inclusion criteria:

1. Male or female patients aged 18-75 years (inclusive)
2. 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
3. Body Mass Index (BMI) =\>18.5 and \<40 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
5. 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:

1. 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.)
2. 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
3. History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
4. 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
5. Use of ustekinumab within 24 weeks prior to Visit 2
6. Had a prior treatment of psoriasis with biologics with inadequate clinical response to therapy as assessed by a dermatologist or the investigator
7. Intake of restricted medications or drugs considered likely to interfere with the safe conduct of the study
8. 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
9. Participation in another trial with an investigational drug within 4 weeks or 5 half-lives (whichever is greater) preceding Visit 2
10. History of alcohol abuse within last 12 months (intake of more than 30 g/day)
11. History of drug abuse within last 12 months or positive drug screen at screening or Visit 2
12. Any blood donation or significant blood loss within 4 weeks prior to Visit 2
13. Unwilling or not capable to abstain from alcoholic beverages one day prior and two days after Visit 2
14. Excessive physical activities (within 1 week prior to Visit 2)
15. Any laboratory value at the screening visit outside the reference range that is of clinical relevance based on physician investigator judgement

Primary outcomes:
measure: Number of patients with good and satisfactory assessment of global tolerability by investigator
timeFrame: 24 weeks
measure: Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator
timeFrame: up to 1 week
measure: Number of participants with adverse events
timeFrame: up to 24 weeks
measure: Number of participants with clinically relevant findings in vital signs
timeFrame: up to 24 weeks
measure: Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results
timeFrame: up to 24 weeks
measure: Number of participants with significant changes from baseline laboratory measurements
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Psoriasis Area and Severity Index (absolute score)
timeFrame: up to 24 weeks
measure: Percentage of participants with Static Physicians Global Assessment (clear and almost clear)
timeFrame: up to 24 weeks
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 24 weeks
measure: tmax (time from dosing to maximum measured concentration)
timeFrame: up to 24 weeks
measure: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: 24 weeks
measure: Psoriasis Area and Severity Index (percentage change from baseline)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Burbank
country: United States
facility: 1311.1.0007 Boehringer Ingelheim Investigational Site
state: California
city: Miami
country: United States
facility: 1311.1.0008 Boehringer Ingelheim Investigational Site
state: Florida
city: Port Orange
country: United States
facility: 1311.1.0003 Boehringer Ingelheim Investigational Site
state: Florida
city: Normal
country: United States
facility: 1311.1.0005 Boehringer Ingelheim Investigational Site
state: Illinois
city: Evansville
country: United States
facility: 1311.1.0006 Boehringer Ingelheim Investigational Site
state: Indiana
city: North Dartmouth
country: United States
facility: 1311.1.0004 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Pittsburgh
country: United States
facility: 1311.1.0002 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Berlin
country: Germany
facility: 1311.1.4901 Boehringer Ingelheim Investigational Site
city: Leeds
country: United Kingdom
facility: 1311.1.0009 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_CHAIR
References:
citation: Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.