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

NCT ID: NCT01577550

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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Conditions

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Psoriasis

Keywords

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ABBV-066 BI 655066 risankizumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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i.v. BI 655066

A subject to receive a single i.v. dose of BI 655066

Group Type EXPERIMENTAL

BI 655066 (very high i.v. dose)

Intervention Type DRUG

Single very high i.v. dose BI 655066

BI 655066 (low i.v. dose)

Intervention Type DRUG

Single low i.v. dose BI 655066

BI 655066 (high medium i.v. dose)

Intervention Type DRUG

Single high medium i.v. dose BI 655066

BI 655066 (very low i.v. dose)

Intervention Type DRUG

Single very low i.v. dose BI 655066

BI 655066 (high i.v. dose)

Intervention Type DRUG

Single high i.v. dose BI 655066

BI 655066 (low medium i.v. dose)

Intervention Type DRUG

Single low medium i.v. dose BI 655066

i.v. placebo

A subject to receive a single i.v. dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo, i.v.

Intervention Type DRUG

Single i.v. administration of placebo

s.c. BI 655066

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

Group Type EXPERIMENTAL

BI 655066 (high s.c. dose)

Intervention Type DRUG

Single high s.c. dose BI 655066

BI 655066 (low s.c. dose)

Intervention Type DRUG

Single low s.c. dose BI 655066

s.c. placebo

A subject to receive a single s.c. dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo, s.c.

Intervention Type DRUG

Single s.c. administration of placebo

Interventions

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BI 655066 (very high i.v. dose)

Single very high i.v. dose BI 655066

Intervention Type DRUG

Placebo, i.v.

Single i.v. administration of placebo

Intervention Type DRUG

BI 655066 (high s.c. dose)

Single high s.c. dose BI 655066

Intervention Type DRUG

BI 655066 (low i.v. dose)

Single low i.v. dose BI 655066

Intervention Type DRUG

BI 655066 (high medium i.v. dose)

Single high medium i.v. dose BI 655066

Intervention Type DRUG

BI 655066 (very low i.v. dose)

Single very low i.v. dose BI 655066

Intervention Type DRUG

BI 655066 (low s.c. dose)

Single low s.c. dose BI 655066

Intervention Type DRUG

BI 655066 (high i.v. dose)

Single high i.v. dose BI 655066

Intervention Type DRUG

Placebo, s.c.

Single s.c. administration of placebo

Intervention Type DRUG

BI 655066 (low medium i.v. dose)

Single low medium i.v. dose BI 655066

Intervention Type DRUG

Other Intervention Names

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ABBV-066 risankizumab ABBV-066 risankizumab ABBV-066 risankizumab ABBV-066 risankizumab ABBV-066 risankizumab ABBV-066 risankizumab ABBV-066 risankizumab ABBV-066 risankizumab ABBV-066 risankizumab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc

Role: STUDY_CHAIR

AbbVie

Locations

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1311.1.0007 Boehringer Ingelheim Investigational Site

Burbank, California, United States

Site Status

1311.1.0008 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1311.1.0003 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Site Status

1311.1.0005 Boehringer Ingelheim Investigational Site

Normal, Illinois, United States

Site Status

1311.1.0006 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Site Status

1311.1.0004 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

1311.1.0002 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

1311.1.4901 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1311.1.0009 Boehringer Ingelheim Investigational Site

Leeds, , United Kingdom

Site Status

Countries

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United States Germany United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31054118 (View on PubMed)

Other Identifiers

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2012-000081-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1311.1

Identifier Type: -

Identifier Source: org_study_id