search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
risankizumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =40% and =85% of predicted normal.
  2. 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.
  3. Must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
  4. Must have documented history of two or more severe asthma exacerbations in the last 12 months.

Exclusion criteria:

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

Sites / Locations

  • WCCT Global, LLC
  • El Camino Hospital
  • IMMUNOe Research Centers
  • Yale New Haven Hospital
  • Clinical Research Trials of Florida, Inc.
  • Northwestern University
  • Johns Hopkins Hospital
  • Brigham and Women's Hospital
  • Washington University School of Medicine
  • VA WNY Healthcare System
  • American Health Research, Inc.
  • Coastal Carolina Health Care, P.A.
  • Wake Forest School of Medicine
  • Temple University School of Medicine
  • University of Pittsburgh Medical Center
  • Research Protocol Mgmt Spc
  • MedTrial, LLC
  • VitaLink Research
  • Respiratory and Sleep Disorders Specialists
  • O and O Alpan, LLC
  • ULB Hopital Erasme
  • Brussels - UNIV St-Luc
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liège
  • Vancouver General Hospital
  • Burlington Lung Clinic
  • Airway Inflammometry Laboratory
  • HOP CHU de Grenoble
  • HOP Nord
  • HOP Arnaud de Villeneuve
  • HOP Nord Laënnec
  • HOP Bichat
  • Praxis Dr. Linnhoff, Berlin
  • MECS Research GmbH, Berlin
  • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
  • Praxis Dr. med. Claus Keller
  • IKF Pneumologie GmbH & Co. KG
  • Medaimun GmbH
  • Hamburger Institut für Therapieforschung GmbH (HIT)
  • Praxis Dr. Hoffmann, Hannover
  • Universitätsklinikum des Saarlandes
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • KPPK GmbH, Studienzentrum
  • KLB Gesundheitsforschung Lübeck GmbH
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Institut für klinische Forschung GmbH
  • IFG Institut für Gesundheitsförderung GmbH
  • Chungbuk National University Hospital
  • Chonnam National University Hospital
  • Korea University Guro Hospital
  • The Catholic University of Korea, St.Paul's Hospital
  • HagaZiekenhuis
  • Leids Universitair Medisch Centrum (LUMC)
  • Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat
  • Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED
  • Univ. Hospital in Krakow,Pulmonology Clinical Dept
  • Barlicki University Hospital No. 1
  • Barlicki University Hospital No. 1
  • Chang Gung Memorial Hospital Keelung
  • China Medical University Hospital
  • Celerion Inc
  • Bradford Royal Infirmary
  • Glenfield Hospital
  • The Medicines Evaluation Unit
  • Wishaw General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Risankizumab

Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition
Time to first asthma worsening during the planned 24 week treatment period according to alternative definition: 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 ≥0.5 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.
Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period
Annualized rate of 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. Mean is Annualized rate.
Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period
Time to first severe asthma exacerbation during the planned 24 week treatment period. Severe asthma exacerbation was 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.
Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period
Annualized rate of severe asthma exacerbation during the planned 24-week treatment period. Severe asthma exacerbation was 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. Mean is Annualized rate.
Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Trough forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Post-bronchodilator forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Weekly Asthma Control Questionaire Score at Week 24
The score at week 24 is the average of the responses to the five ACQ5 questions for the week preceding the Week 24 visit. The ACQ5 asks patients to rate the severity of their asthma symptoms and the degree to which asthma affected their sleep and other daily activities. The scale for all five ACQ5 questions range from the best possible answer of 0 (No symptoms, None, Never) to the worst possible answer of 6 (very severe, unable to sleep, totally limited). The ACQ5 score can range from 0.0 (best) to 6.0 (worst).

Full Information

First Posted
May 11, 2015
Last Updated
March 18, 2019
Sponsor
AbbVie
Collaborators
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT02443298
Brief Title
Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
Official Title
Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Subcutaneously Administered BI 655066/ABBV-066 (Risankizumab) as add-on Therapy Over 24 Weeks in Patients With Severe Persistent Asthma.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 23, 2015 (Actual)
Primary Completion Date
October 13, 2017 (Actual)
Study Completion Date
February 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risankizumab
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Matching placebo for risankizumab
Intervention Type
Drug
Intervention Name(s)
risankizumab
Other Intervention Name(s)
ABBV-066, BI 655066
Intervention Description
Monoclonal IgG antibody
Primary Outcome Measure Information:
Title
Time to First Asthma Worsening During the Planned 24 Week Treatment Period
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition
Description
Time to first asthma worsening during the planned 24 week treatment period according to alternative definition: 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 ≥0.5 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.
Time Frame
24 weeks
Title
Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period
Description
Annualized rate of 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. Mean is Annualized rate.
Time Frame
24 weeks
Title
Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period
Description
Time to first severe asthma exacerbation during the planned 24 week treatment period. Severe asthma exacerbation was 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.
Time Frame
24 weeks
Title
Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period
Description
Annualized rate of severe asthma exacerbation during the planned 24-week treatment period. Severe asthma exacerbation was 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. Mean is Annualized rate.
Time Frame
24 weeks
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Description
Trough forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Time Frame
Baseline and 24 weeks
Title
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Description
Post-bronchodilator forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Time Frame
Baseline and 24 weeks
Title
Weekly Asthma Control Questionaire Score at Week 24
Description
The score at week 24 is the average of the responses to the five ACQ5 questions for the week preceding the Week 24 visit. The ACQ5 asks patients to rate the severity of their asthma symptoms and the degree to which asthma affected their sleep and other daily activities. The scale for all five ACQ5 questions range from the best possible answer of 0 (No symptoms, None, Never) to the worst possible answer of 6 (very severe, unable to sleep, totally limited). The ACQ5 score can range from 0.0 (best) to 6.0 (worst).
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
WCCT Global, LLC
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
VA WNY Healthcare System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
American Health Research, Inc.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Coastal Carolina Health Care, P.A.
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Temple University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Research Protocol Mgmt Spc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
MedTrial, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
VitaLink Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Respiratory and Sleep Disorders Specialists
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
O and O Alpan, LLC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
ULB Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Brussels - UNIV St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Burlington Lung Clinic
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Airway Inflammometry Laboratory
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
HOP CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
HOP Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
HOP Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
HOP Nord Laënnec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
HOP Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Praxis Dr. Linnhoff, Berlin
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
MECS Research GmbH, Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Praxis Dr. med. Claus Keller
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
IKF Pneumologie GmbH & Co. KG
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Medaimun GmbH
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Hamburger Institut für Therapieforschung GmbH (HIT)
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Praxis Dr. Hoffmann, Hannover
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
KPPK GmbH, Studienzentrum
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
KLB Gesundheitsforschung Lübeck GmbH
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Institut für klinische Forschung GmbH
City
Neu-Isenburg
ZIP/Postal Code
63263
Country
Germany
Facility Name
IFG Institut für Gesundheitsförderung GmbH
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
361-771
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St.Paul's Hospital
City
Seoul
ZIP/Postal Code
130-709
Country
Korea, Republic of
Facility Name
HagaZiekenhuis
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum (LUMC)
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED
City
Krakow
ZIP/Postal Code
30033
Country
Poland
Facility Name
Univ. Hospital in Krakow,Pulmonology Clinical Dept
City
Krakow
ZIP/Postal Code
31066
Country
Poland
Facility Name
Barlicki University Hospital No. 1
City
Lodz
ZIP/Postal Code
90 141
Country
Poland
Facility Name
Barlicki University Hospital No. 1
City
Lodz
ZIP/Postal Code
90141
Country
Poland
Facility Name
Chang Gung Memorial Hospital Keelung
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Celerion Inc
City
Belfast
ZIP/Postal Code
BT9 6AD
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
The Medicines Evaluation Unit
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Facility Name
Wishaw General Hospital
City
Wishaw
ZIP/Postal Code
ML2 0DP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34706172
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs