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

NCT01577550 | Completed Phase 1

• 2 other identifiers: 1311.12012-000081-37
• Study Type: interventional
• Target: 39
• Locations: 3 countries
• Sites: 9

Brief Summary

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

Conditions

Psoriasis

Keywords

ABBV-066; BI 655066; risankizumab

Outcome Measures

Primary Outcomes (6)

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

  24 weeks

• Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator

  up to 1 week

• Number of participants with adverse events

  up to 24 weeks

• Number of participants with clinically relevant findings in vital signs

  up to 24 weeks

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

  up to 24 weeks

• Number of participants with significant changes from baseline laboratory measurements

  up to 24 weeks

Secondary Outcomes (6)

• Psoriasis Area and Severity Index (absolute score)

  up to 24 weeks

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

  up to 24 weeks

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 24 weeks

• tmax (time from dosing to maximum measured concentration)

  up to 24 weeks

• AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  24 weeks

Study Arms (4)

i.v. BI 655066

EXPERIMENTAL

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)

i.v. placebo

PLACEBO COMPARATOR

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

Drug: Placebo, i.v.

s.c. BI 655066

EXPERIMENTAL

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)

s.c. placebo

PLACEBO COMPARATOR

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

Drug: Placebo, s.c.

Interventions

BI 655066 (very high i.v. dose) DRUG

Single very high i.v. dose BI 655066

Also known as: ABBV-066, risankizumab

i.v. BI 655066

Placebo, i.v. DRUG

Single i.v. administration of placebo

i.v. placebo

BI 655066 (high s.c. dose) DRUG

Single high s.c. dose BI 655066

Also known as: ABBV-066, risankizumab

s.c. BI 655066

BI 655066 (low i.v. dose) DRUG

Single low i.v. dose BI 655066

Also known as: ABBV-066, risankizumab

i.v. BI 655066

BI 655066 (high medium i.v. dose) DRUG

Single high medium i.v. dose BI 655066

Also known as: ABBV-066, risankizumab

i.v. BI 655066

BI 655066 (very low i.v. dose) DRUG

Single very low i.v. dose BI 655066

Also known as: ABBV-066, risankizumab

i.v. BI 655066

BI 655066 (low s.c. dose) DRUG

Single low s.c. dose BI 655066

Also known as: ABBV-066, risankizumab

s.c. BI 655066

BI 655066 (high i.v. dose) DRUG

Single high i.v. dose BI 655066

Also known as: ABBV-066, risankizumab

i.v. BI 655066

Placebo, s.c. DRUG

Single s.c. administration of placebo

Also known as: ABBV-066, risankizumab

s.c. placebo

BI 655066 (low medium i.v. dose) DRUG

Single low medium i.v. dose BI 655066

Also known as: ABBV-066, risankizumab

i.v. BI 655066

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18-75 years (inclusive)
• 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
• Body Mass Index (BMI) =\>18.5 and \<40 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
• 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.

You may not qualify if:

• 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
• History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
• 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
• Use of ustekinumab within 24 weeks prior to Visit 2
• Had a prior treatment of psoriasis with biologics with inadequate clinical response to therapy as assessed by a dermatologist or the investigator
• Intake of restricted medications or drugs considered likely to interfere with the safe conduct of the study
• 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
• Participation in another trial with an investigational drug within 4 weeks or 5 half-lives (whichever is greater) preceding Visit 2
• History of alcohol abuse within last 12 months (intake of more than 30 g/day)
• History of drug abuse within last 12 months or positive drug screen at screening or Visit 2
• Any blood donation or significant blood loss within 4 weeks prior to Visit 2
• Unwilling or not capable to abstain from alcoholic beverages one day prior and two days after Visit 2
• Excessive physical activities (within 1 week prior to Visit 2)
• Any laboratory value at the screening visit outside the reference range that is of clinical relevance based on physician investigator judgement

Sponsors & Collaborators

• AbbVie: lead
• Boehringer Ingelheim: collaborator

Study Sites (9)

1311.1.0007 Boehringer Ingelheim Investigational Site

Burbank, California, United States

Location

1311.1.0008 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1311.1.0003 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Location

1311.1.0005 Boehringer Ingelheim Investigational Site

Normal, Illinois, United States

Location

1311.1.0006 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

1311.1.0004 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1311.1.0002 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1311.1.4901 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1311.1.0009 Boehringer Ingelheim Investigational Site

Leeds, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31054118 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• AbbVie Inc

  AbbVie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 16, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: May 1, 2014
• Last Updated: November 16, 2016

Record last verified: 2016-11

Locations

DE (1); GB (1); US (7)