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

Psoriasis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577550
• Other study ID #: 1311.1
• Secondary ID: 2012-000081-37
• Status: Completed
• Phase: Phase 1
• First received: April 10, 2012
• Last updated: November 15, 2016
• Start date: April 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstituteUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BI 655066 (very high i.v. dose)
Single very high i.v. dose BI 655066
• Placebo, i.v.
Single i.v. administration of placebo
• BI 655066 (high s.c. dose)
Single high s.c. dose BI 655066
• BI 655066 (low i.v. dose)
Single low i.v. dose BI 655066
• BI 655066 (high medium i.v. dose)
Single high medium i.v. dose BI 655066
• BI 655066 (very low i.v. dose)
Single very low i.v. dose BI 655066
• BI 655066 (low s.c. dose)
Single low s.c. dose BI 655066
• BI 655066 (high i.v. dose)
Single high i.v. dose BI 655066
• Placebo, s.c.
Single s.c. administration of placebo
• BI 655066 (low medium i.v. dose)
Single low medium i.v. dose BI 655066

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with good and satisfactory assessment of global tolerability by investigator		24 weeks	No
Primary	Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator		up to 1 week	No
Primary	Number of participants with adverse events		up to 24 weeks	No
Primary	Number of participants with clinically relevant findings in vital signs		up to 24 weeks	No
Primary	Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results		up to 24 weeks	No
Primary	Number of participants with significant changes from baseline laboratory measurements		up to 24 weeks	No
Secondary	Psoriasis Area and Severity Index (absolute score)		up to 24 weeks	No
Secondary	Percentage of participants with Static Physicians Global Assessment (clear and almost clear)		up to 24 weeks	No
Secondary	Cmax (maximum measured concentration of the analyte in plasma)		up to 24 weeks	No
Secondary	tmax (time from dosing to maximum measured concentration)		up to 24 weeks	No
Secondary	AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)		24 weeks	No
Secondary	Psoriasis Area and Severity Index (percentage change from baseline)		up to 24 weeks	No