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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01577550
First received: April 10, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Psoriasis
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)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of patients with good and satisfactory assessment of global tolerability by investigator [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant findings in vital signs [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psoriasis Area and Severity Index (absolute score) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with Static Physicians Global Assessment (clear and almost clear) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index (percentage change from baseline) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: April 2012
Estimated Study Completion Date: May 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: BI 655066 (low i.v. dose)
Single low i.v. dose BI 655066
Drug: BI 655066 (high medium i.v. dose)
Single high medium i.v. dose BI 655066
Drug: BI 655066 (very low i.v. dose)
Single very low i.v. dose BI 655066
Drug: BI 655066 (high i.v. dose)
Single high i.v. dose BI 655066
Drug: BI 655066 (low medium i.v. dose)
Single low medium i.v. dose BI 655066
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
Drug: BI 655066 (low s.c. dose)
Single low s.c. dose BI 655066
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577550

Locations
United States, California
1311.1.0007 Boehringer Ingelheim Investigational Site
Burbank, California, United States
United States, Florida
1311.1.0008 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1311.1.0003 Boehringer Ingelheim Investigational Site
Port Orange, Florida, United States
United States, Illinois
1311.1.0005 Boehringer Ingelheim Investigational Site
Normal, Illinois, United States
United States, Indiana
1311.1.0006 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
United States, Massachusetts
1311.1.0004 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
United States, Pennsylvania
1311.1.0002 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
Germany
1311.1.4901 Boehringer Ingelheim Investigational Site
Berlin, Germany
United Kingdom
1311.1.0009 Boehringer Ingelheim Investigational Site
Leeds, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01577550     History of Changes
Other Study ID Numbers: 1311.1, 2012-000081-37
Study First Received: April 10, 2012
Last Updated: April 2, 2014
Health Authority: Germany: Paul-Ehrlich-Institute
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 14, 2014