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CompletedNCT01577550Updated Nov 16, 2016

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

A Phase 1 interventional study of BI 655066 (very high i.v. dose) and Placebo, i.v. in Psoriasis, sponsored by AbbVie. Completed at 9 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-16.

Sponsored by AbbVie · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Psoriasis

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Keywords

  • ABBV-066
  • BI 655066
  • risankizumab
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 39 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
39 participants (actual)

Study arms

  • 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) · 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

    Drug: Placebo, i.v.

  • Experimental
    s.c. BI 655066

    A subject to receive a single s.c. dose of BI 655066

    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

    Drug: Placebo, s.c.

Interventions

  • DrugBI 655066 (very high i.v. dose)

    Single very high i.v. dose BI 655066

    Also known as: ABBV-066, risankizumab

  • DrugPlacebo, i.v.

    Single i.v. administration of placebo

  • DrugBI 655066 (high s.c. dose)

    Single high s.c. dose BI 655066

    Also known as: ABBV-066, risankizumab

  • DrugBI 655066 (low i.v. dose)

    Single low i.v. dose BI 655066

    Also known as: ABBV-066, risankizumab

  • DrugBI 655066 (high medium i.v. dose)

    Single high medium i.v. dose BI 655066

    Also known as: ABBV-066, risankizumab

  • DrugBI 655066 (very low i.v. dose)

    Single very low i.v. dose BI 655066

    Also known as: ABBV-066, risankizumab

  • DrugBI 655066 (low s.c. dose)

    Single low s.c. dose BI 655066

    Also known as: ABBV-066, risankizumab

  • DrugBI 655066 (high i.v. dose)

    Single high i.v. dose BI 655066

    Also known as: ABBV-066, risankizumab

  • DrugPlacebo, s.c.

    Single s.c. administration of placebo

    Also known as: ABBV-066, risankizumab

  • DrugBI 655066 (low medium i.v. dose)

    Single low medium i.v. dose BI 655066

    Also known as: ABBV-066, risankizumab

06

What researchers measure

Primary outcomes

  1. Number of patients with good and satisfactory assessment of global tolerability by investigator

    Time frame: 24 weeks

  2. 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

  3. Number of participants with adverse events

    Time frame: up to 24 weeks

  4. Number of participants with clinically relevant findings in vital signs

    Time frame: up to 24 weeks

  5. Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results

    Time frame: up to 24 weeks

  6. Number of participants with significant changes from baseline laboratory measurements

    Time frame: up to 24 weeks

Secondary outcomes

  1. Psoriasis Area and Severity Index (absolute score)

    Time frame: up to 24 weeks

  2. Percentage of participants with Static Physicians Global Assessment (clear and almost clear)

    Time frame: up to 24 weeks

  3. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 24 weeks

  4. tmax (time from dosing to maximum measured concentration)

    Time frame: up to 24 weeks

  5. 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

  6. Psoriasis Area and Severity Index (percentage change from baseline)

    Time frame: up to 24 weeks

07

Study locations

9 sites
  • 1311.1.0007 Boehringer Ingelheim Investigational Site
    Burbank, California, United States
  • 1311.1.0008 Boehringer Ingelheim Investigational Site
    Miami, Florida, United States
  • 1311.1.0003 Boehringer Ingelheim Investigational Site
    Port Orange, Florida, United States
  • 1311.1.0005 Boehringer Ingelheim Investigational Site
    Normal, Illinois, United States
  • 1311.1.0006 Boehringer Ingelheim Investigational Site
    Evansville, Indiana, 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
  • 1311.1.4901 Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • 1311.1.0009 Boehringer Ingelheim Investigational Site
    Leeds, United Kingdom
08

References and documents

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. PubMed 31054118 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01577550
Lead sponsor
AbbVie
Collaborators
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Apr 16, 2012
Start date
Apr 2012
Primary completion
Oct 2013
Completion
May 2014
Last update
Nov 16, 2016

Study contacts

AbbVie Inc
study chair · AbbVie
View the source record on ClinicalTrials.gov ↗

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