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

April 10, 2012
April 2, 2014
April 2012
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Number of patients with ¿good¿ and ¿satisfactory¿ assessment of global tolerability by investigator [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • 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: Yes ]
  • Number of participants with adverse events [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with clinically relevant findings in vital signs [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01577550 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Psoriasis Area and Severity Index (absolute score) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with Static Physicians Global Assessment (clear and almost clear) [ Time Frame: 12 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: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Psoriasis
  • Drug: BI 655066 (very high i.v. dose)
    Single very high i.v. dose BI 655066
  • Drug: Placebo, i.v.
    Single i.v. administration of placebo
  • Drug: BI 655066 (high s.c. dose)
    Single high s.c. 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 (low s.c. dose)
    Single low s.c. dose BI 655066
  • Drug: BI 655066 (high i.v. dose)
    Single high i.v. dose BI 655066
  • Drug: Placebo, s.c.
    Single s.c. administration of placebo
  • Drug: BI 655066 (low medium i.v. dose)
    Single low medium i.v. dose BI 655066
  • Experimental: i.v. BI 655066
    A subject to receive a single i.v. dose of BI 655066
    Interventions:
    • 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)
  • Placebo Comparator: i.v. placebo
    A subject to receive a single i.v. dose of placebo
    Intervention: Drug: Placebo, i.v.
  • Experimental: s.c. BI 655066
    A subject to receive a single s.c. dose of BI 655066
    Interventions:
    • Drug: BI 655066 (high s.c. dose)
    • Drug: BI 655066 (low s.c. dose)
  • Placebo Comparator: s.c. placebo
    A subject to receive a single s.c. dose of placebo
    Intervention: Drug: Placebo, s.c.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
39
May 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   United Kingdom
 
NCT01577550
1311.1, 2012-000081-37
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP