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

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)

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: BI 655066 (very high i.v. 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 (high i.v. dose); Drug: BI 655066 (low medium i.v. dose); Drug: Placebo, i.v.; Drug: BI 655066 (high s.c. dose); Drug: BI 655066 (low s.c. dose); Drug: Placebo, s.c.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • 1311.1.4901 Boehringer Ingelheim Investigational Site
• United Kingdom
  • Leeds, United Kingdom
    • 1311.1.0009 Boehringer Ingelheim Investigational Site
• United States
  • California
    • Burbank, California, United States
      • 1311.1.0007 Boehringer Ingelheim Investigational Site
  • Florida
    • Miami, Florida, United States
      • 1311.1.0008 Boehringer Ingelheim Investigational Site
    • Port Orange, Florida, United States
      • 1311.1.0003 Boehringer Ingelheim Investigational Site
  • Illinois
    • Normal, Illinois, United States
      • 1311.1.0005 Boehringer Ingelheim Investigational Site
  • Indiana
    • Evansville, Indiana, United States
      • 1311.1.0006 Boehringer Ingelheim Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States
      • 1311.1.0004 Boehringer Ingelheim Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
      • 1311.1.0002 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: i.v. BI 655066; A subject to receive a single i.v. dose of BI 655066	Drug: BI 655066 (very high i.v. dose); Single very high i.v. dose BI 655066; Other Names: ABBV-066; risankizumab; Drug: BI 655066 (low i.v. dose); Single low i.v. dose BI 655066; Other Names: ABBV-066; risankizumab; Drug: BI 655066 (high medium i.v. dose); Single high medium i.v. dose BI 655066; Other Names: ABBV-066; risankizumab; Drug: BI 655066 (very low i.v. dose); Single very low i.v. dose BI 655066; Other Names: ABBV-066; risankizumab; Drug: BI 655066 (high i.v. dose); Single high i.v. dose BI 655066; Other Names: ABBV-066; risankizumab; Drug: BI 655066 (low medium i.v. dose); Single low medium i.v. dose BI 655066; Other Names: ABBV-066; risankizumab
Placebo Comparator: i.v. placebo; A subject to receive a single i.v. dose of placebo	Drug: Placebo, i.v.; Single i.v. administration of placebo
Experimental: s.c. BI 655066; A subject to receive a single s.c. dose of BI 655066	Drug: BI 655066 (high s.c. dose); Single high s.c. dose BI 655066; Other Names: ABBV-066; risankizumab; Drug: BI 655066 (low s.c. dose); Single low s.c. dose BI 655066; Other Names: ABBV-066; risankizumab
Placebo Comparator: s.c. placebo; A subject to receive a single s.c. dose of placebo	Drug: Placebo, s.c.; Single s.c. administration of placebo; Other Names: ABBV-066; risankizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Boehringer Ingelheim
• Investigators: Study Chair: AbbVie Inc, AbbVie

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (Estimate): April 16, 2012

Study Record Updates

• Last Update Posted (Estimate): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 15, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: ABBV-066; BI 655066; risankizumab
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: 1311.1; 2012-000081-37 (EudraCT Number: EudraCT)