Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).

Key facts

Study ID

NCT02443298

Run by

AbbVie

People needed

214

Starts

2015-06-23

Expected to finish

2018-02-02

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =40% and =85% of predicted normal.
• One year history of asthma diagnosed by a physician, and have FEV1 reversibility of =12% and an absolute change of at least 200 mL after administration of 400 µg salbutamol.
• Must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
• Must have documented history of two or more severe asthma exacerbations in the last 12 months.

You may not qualify if…

• Patients with a significant disease other than asthma.
• Patients who are not able to produce sputum or sputum samples of sufficient quality.
• Patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
• Patients diagnosed with any concurrent respiratory disease.
• Recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
• Patients who have undergone thoracotomy with pulmonary resection.
• Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
• Patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
• Pregnant or nursing women.
• Women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
• Clinically relevant acute infections or chronic infections.
• Have received any live bacterial or live viral vaccination in the last12 weeks.
• Have received Bacille Calmette-Guerin (BCG) vaccination in the last 12 months.
• Have received treatment with ustekinumab (Stelara®).
• Have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.

Where it is running

• El Camino Hospital — Mountain View, California, United States
• IMMUNOe Research Centers — Centennial, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Clinical Research Trials of Florida, Inc. — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• VA WNY Healthcare System — Buffalo, New York, United States
• American Health Research, Inc. — Charlotte, North Carolina, United States
• Coastal Carolina Health Care, P.A. — New Bern, North Carolina, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• Temple University School of Medicine — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Research Protocol Mgmt Spc — Pittsburgh, Pennsylvania, United States
• MedTrial, LLC — Columbia, South Carolina, United States
• VitaLink Research — Greenville, South Carolina, United States
• Respiratory and Sleep Disorders Specialists — The Woodlands, Texas, United States
• O and O Alpan, LLC — Fairfax, Virginia, United States
• ULB Hopital Erasme — Brussels, Belgium
• Brussels - UNIV St-Luc — Brussels, Belgium
• UZ Leuven — Leuven, Belgium
• Centre Hospitalier Universitaire de Liège — Liège, Belgium
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• WCCT Global, LLC — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

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