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

NCT02443298 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1311.142014-004932-20
• Study Type: interventional
• Target: 214
• Locations: 10 countries
• Sites: 65

Brief Summary

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).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Time to First Asthma Worsening During the Planned 24 Week Treatment Period

  Time to first asthma worsening during the planned 24 week treatment period: Asthma worsening was defined as the occurrence of any one of the following four criteria: a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.

  24 weeks

Secondary Outcomes (7)

• Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition

  24 weeks

• Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period

  24 weeks

• Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period

  24 weeks

• Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period

  24 weeks

• Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24

  Baseline and 24 weeks

Study Arms (2)

Risankizumab

EXPERIMENTAL

Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20).

Drug: risankizumab

Placebo

PLACEBO COMPARATOR

Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20).

Drug: placebo

Interventions

placebo DRUG

Matching placebo for risankizumab

Placebo

risankizumab DRUG

Monoclonal IgG antibody

Also known as: ABBV-066, BI 655066

Risankizumab

Eligibility Criteria

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

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.

Sponsors & Collaborators

• AbbVie: lead
• Boehringer Ingelheim: collaborator

Study Sites (65)

WCCT Global, LLC

Costa Mesa, California, 92626, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06504, United States

Location

Clinical Research Trials of Florida, Inc.

Tampa, Florida, 33607, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

VA WNY Healthcare System

Buffalo, New York, 14215, United States

Location

American Health Research, Inc.

Charlotte, North Carolina, 28207, United States

Location

Coastal Carolina Health Care, P.A.

New Bern, North Carolina, 28562, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27104, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Research Protocol Mgmt Spc

Pittsburgh, Pennsylvania, 15243, United States

Location

MedTrial, LLC

Columbia, South Carolina, 29204, United States

Location

VitaLink Research

Greenville, South Carolina, 29615, United States

Location

Respiratory and Sleep Disorders Specialists

The Woodlands, Texas, 77380, United States

Location

O and O Alpan, LLC

Fairfax, Virginia, 22030, United States

Location

ULB Hopital Erasme

Brussels, 1070, Belgium

Location

Brussels - UNIV St-Luc

Brussels, 1200, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Burlington Lung Clinic

Burlington, Ontario, L7N 3V2, Canada

Location

Airway Inflammometry Laboratory

Hamilton, Ontario, L8N 4A6, Canada

Location

HOP CHU de Grenoble

Grenoble, 38043, France

Location

HOP Nord

Marseille, 13915, France

Location

HOP Arnaud de Villeneuve

Montpellier, 34295, France

Location

HOP Nord Laënnec

Nantes, 44093, France

Location

HOP Bichat

Paris, 75018, France

Location

Praxis Dr. Linnhoff, Berlin

Berlin, 10717, Germany

Location

MECS Research GmbH, Berlin

Berlin, 12203, Germany

Location

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

Bochum, 44789, Germany

Location

Praxis Dr. med. Claus Keller

Frankfurt, 60389, Germany

Location

IKF Pneumologie GmbH & Co. KG

Frankfurt, 60596, Germany

Location

Medaimun GmbH

Frankfurt, 60596, Germany

Location

Hamburger Institut für Therapieforschung GmbH (HIT)

Hamburg, 20354, Germany

Location

Praxis Dr. Hoffmann, Hannover

Hanover, 30173, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, 66421, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

KPPK GmbH, Studienzentrum

Koblenz, 56068, Germany

Location

KLB Gesundheitsforschung Lübeck GmbH

Lübeck, 23552, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Institut für klinische Forschung GmbH

Neu-Isenburg, 63263, Germany

Location

IFG Institut für Gesundheitsförderung GmbH

Rüdersdorf, 15562, Germany

Location

Leids Universitair Medisch Centrum (LUMC)

Leiden, 2333 ZA, Netherlands

Location

HagaZiekenhuis

The Hague, 2545 CH, Netherlands

Location

Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat

Katowice, 40-752, Poland

Location

Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED

Krakow, 30033, Poland

Location

Univ. Hospital in Krakow,Pulmonology Clinical Dept

Krakow, 31066, Poland

Location

Barlicki University Hospital No. 1

Lodz, 90 141, Poland

Location

Barlicki University Hospital No. 1

Lodz, 90141, Poland

Location

Chungbuk National University Hospital

Cheongju-si, 361-771, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

The Catholic University of Korea, St.Paul's Hospital

Seoul, 130-709, South Korea

Location

Chang Gung Memorial Hospital Keelung

Keelung, 20401, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Celerion Inc

Belfast, BT9 6AD, United Kingdom

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

The Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Wishaw General Hospital

Wishaw, ML2 0DP, United Kingdom

Location

Related Publications (1)

• Brightling CE, Nair P, Cousins DJ, Louis R, Singh D. Risankizumab in Severe Asthma - A Phase 2a, Placebo-Controlled Trial. N Engl J Med. 2021 Oct 28;385(18):1669-1679. doi: 10.1056/NEJMoa2030880.

  PMID: 34706172 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

1-800-633-9110

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 13, 2015
• Study Start: June 23, 2015
• Primary Completion: October 13, 2017
• Study Completion: February 2, 2018
• Last Updated: April 10, 2019
• Results First Posted: April 10, 2019

Record last verified: 2019-03

Locations

NL (2); TW (2); GB (5); CA (3); FR (5); DE (15); PL (5); BE (4); US (20); KR (4)